Early Cold Stored Platelet Transfusion Following Severe Injury: A Randomized Clinical Trial.

OBJECTIVE: To determine the feasibility, efficacy, and safety of early cold stored platelet transfusion compared with standard care resuscitation in patients with hemorrhagic shock. BACKGROUND: Data demonstrating the safety and efficacy of early cold stored platelet transfusion are lacking following severe injury. METHODS: A phase 2, multicenter, randomized, open label, clinical trial was performed at 5 US trauma centers. Injured patients at risk of large volume blood transfusion and the need for hemorrhage control procedures were enrolled and randomized. The intervention was the early transfusion of a single apheresis cold stored platelet unit, stored for up to 14 days versus standard care resuscitation. The primary outcome was feasibility and the principal clinical outcome for efficacy and safety was 24-hour mortality. RESULTS: Mortality at 24 hours was 5.9% in patients who were randomized to early cold stored platelet transfusion compared with 10.2% in the standard care arm (difference, -4.3%; 95% CI, -12.8% to 3.5%; P =0.26). No significant differences were found for any of the prespecified ancillary outcomes. Rates of arterial and/or venous thromboembolism and adverse events did not differ across treatment groups. CONCLUSIONS AND RELEVANCE: In severely injured patients, early cold stored platelet transfusion is feasible, safe and did not result in a significant lower rate of 24-hour mortality. Early cold stored platelet transfusion did not result in a higher incidence of arterial and/or venous thrombotic complications or adverse events. The storage age of the cold stored platelet product was not associated with significant outcome differences. TRIAL REGISTRATION: ClinicalTrials.gov identifier: NCT04667468.

Whole blood: Total blood product ratio impacts survival in injured children.

BACKGROUND: Some studies in both children and adults have shown a mortality benefit for the use of low titer group O whole blood (LTOWB) compared with component therapy for traumatic resuscitation. Although LTOWB is not widely available at pediatric trauma centers, its use is increasing. We hypothesized that in children who received whole blood after injury, the proportion of whole blood in relation to the total blood product resuscitation volume would impact survival. METHODS: The trauma database from a single academic pediatric Level I trauma center was queried for pediatric (age <18 years) recipients of LTOWB after injury (years 2015-2022). Weight-based blood product (LTOWB, red blood cells, plasma, and platelet) transfusion volumes during the first 24 hours of admission were recorded. The ratio of LTOWB to total transfusion volume was calculated. The primary outcome was in-hospital mortality. Multivariable logistic regression model adjusted for the following variables: age, sex, mechanism of injury, Injury Severity Score, shock index, and Glasgow Coma Scale score. Adjusted odds ratio representing the change in the odds of mortality by a 10% increase in the LTOWB/total transfusion volume ratio was reported. RESULTS: There were 95 pediatric LTOWB recipients included in the analysis, with median (interquartile range [IQR]) age of 10 years (5-14 years), 58% male, median (IQR) Injury Severity Score of 26 (17-35), 25% penetrating mechanism. The median (IQR) volume of LTOWB transfused was 17 mL/kg (15-35 mL/kg). Low titer group O whole blood comprised a median (IQR) of 59% (33-100%) of the total blood product resuscitation. Among patients who received LTOWB, there was a 38% decrease in in-hospital mortality for each 10% increase in the proportion of WB within total transfusion volume ( p < 0.001) after adjusting for age, sex, mechanism of injury, Injury Severity Score, shock index, and Glasgow Coma Scale score. CONCLUSION: Increased proportions of LTOWB within the total blood product resuscitation was independently associated with survival in injured children. Based on existing data that suggests safety and improved outcomes with whole blood, consideration may be given to increasing the use of LTOWB over CT resuscitation in pediatric trauma resuscitation. LEVEL OF EVIDENCE: Therapeutic/Care Management; Level III.

Vascular access complications associated with resuscitative endovascular balloon occlusion of the aorta in adult trauma patients: A systematic review and meta-analysis.

BACKGROUND: Resuscitative endovascular balloon occlusion of the aorta (REBOA) is gaining popularity worldwide for managing hypotensive trauma patients. Vascular access complications related to REBOA placement have been reported, with some cases resulting in permanent morbidity. We aim to capitalize on the increase in literature to further describe and estimate the incidence of REBOA-associated vascular access complications in adult trauma patients. METHODS: We searched Medline, EMBASE, Scopus, and CINAHL for studies reporting vascular access complications of REBOA in adult trauma patients from inception to October 14, 2021. Studies reporting data from adult trauma patients who underwent REBOA insertion were eligible. Exclusion criteria included patients 15 years and younger, nontrauma patients, non-REBOA use, non-vascular access complications and patient duplication. Study data was abstracted using the PRISMA checklist and verified independently by three reviewers. Meta-analysis of proportions was performed using a random effects model with Freeman-Turkey double-arcsine transformation. Post hoc meta-regression by year of publication, sheath-size, and geographic region was also performed. The incidence of vascular access complications from REBOA insertion was the primary outcome of interest. Subgroup analysis was performed by degree of bias, sheath size, technique of vascular access, provider specialty, geographical region, and publication year. RESULTS: Twenty-four articles were included in the systematic review and the meta-analysis, for a total of 675 trauma patients who underwent REBOA insertion. The incidence of vascular access complications was 8% (95% confidence interval, 5%-13%). In post hoc meta-regression adjusting for year of publication and geographic region, the use of a smaller (7-Fr) sheath was associated with a decreased incidence of vascular access complications (odds ratio, 0.87; 95% confidence interval, 0.75-0.99; p = 0.046; R 2 = 35%; I 2 = 48%). CONCLUSION: This study provides a benchmark for quality of care in terms of vascular access complications related to REBOA insertion in adult trauma patients. Smaller sheath size may be associated with a decrease in vascular access complications. LEVEL OF EVIDENCE: Systematic Review and Meta-Analysis; Level III.

Seguridad, efectividad y eficiencia del Catéter de Resucitación Endovascular para Oclusión de la Aorta (REBOA) / Safety, effectiveness and efficiency of Resuscitative Endovascular Ballon Occlusión of the Aorta (REBOA)

INTRODUCCIÓN: La patología traumática se encuentra entre las 5 principales causas de mortalidad, de ellas la hemorragia crítica traumática (HECTRA) es la principal causa de muerte evitable después de un traumatismo, suponiendo el 50% de las muertes en las primeras 24 horas. Según la base de datos RETRAUCI, aproximadamente un 6% de los pacientes ingresados en las UCI de Hospitales españoles por traumatismo presentan HECTRA, con una mortalidad hospitalaria del 35%. Teniendo en cuenta que esa mortalidad se refiere solo a los pacientes que ingresan en UCI, es muy probable que la mortalidad real de las HECTRA sea mucho mayor, si se incorporan los datos de muertes extrahospilatarias o en urgencias. El espectro de acretismo placentario (EAP) es una complicación obstétrica compleja asociada a una elevada morbilidad materna. Es un trastorno relativamente nuevo de la placentación, y es consecuencia de daños en la interfase endometrio-miometrio de la pared uterina. El EAP se produce en aproximadamente 1 de cada 1.000 partos. Estas cifras presentan variaciones importantes, probablemente debidas a la definición de la población de estudio, en función de la cual pueden oscilar entre el 0,04 al 0,9%. El EAP supone el 23% de las histerectomías periparto. El dispositivo REBOA (Balón endovascular resucitativo de oclusión aórtica) está compuesto por un catéter con un globo y la vaina de colocación. La colocación se realiza por inserción en arteria femoral. Una vez se ha inflado el globo del catéter REBOA de forma proximal a la lesión, se genera una obstrucción arterial que pretende evitar la hemorragia y mantener la irrigación mínima del cerebro, corazón y pulmones durante el tiempo necesario para que el paciente reciba atención sanitaria adecuada. Cuando REBOA es utilizada adecuadamente por profesionales con experiencia puede mejorar los resultados del subgrupo de pacientes con las lesiones más graves y las hemorragias más extensas. Los riesgos de REBOA incluyen la isquemia visceral total, la pérdida de miembros inferiores, la exacerbación de lesiones cerebrales traumáticas, la isquemia de la médula espinal, la pérdida rápida de sangre proximal y el efecto de lesión por reperfusión. En el caso del EAP, REBOA es una técnica preventiva alternativa y proporciona una oclusión más proximal. Esta técnica también se ha utilizado como complemento de la cirugía conservadora y tiene la ventaja de realizar un bloqueo adicional del riego de la placenta desde las arterias ilíacas externas, así como de detener el flujo en la arteria sacra media, lumbar baja y, en algunos casos, la arteria mesentérica inferior. REBOA se inserta con guía fluoroscópica antes del parto. Suele colocarse por debajo del origen de las arterias renales para evitar la isquemia de los riñones o las vísceras abdominales. El balón se inflaría tras el alumbramiento para prevenir la hemorragia. En España, la técnica REBOA se está utilizando cada vez más en hospitales especializados en cirugía traumática y en el tratamiento de pacientes con lesiones graves, del mismo modo que ha comenzado a utilizarse de modo preventivo en partos de mujeres con placenta acreta. OBJETIVO: Conocer la seguridad, efectividad y eficiencia de la técnica REBOA en pacientes con hemorragias abdominales, retroperitoneales y pélvicas o con espectro de acretismo placentario (EAP). METODOLOGÍA: Se ha realizado una revisión sistemática de la literatura científica disponible sobre efectividad, seguridad y eficiencia de REBOA en pacientes con hemorragia abdomino-pélvica traumática (REBOA terapéutica) o con EAP (REBOA preventiva). RESULTADOS: La RS llevada a cabo arrojó un resultado de 219 referencias de estudios, sin contar duplicados. De entre ellas se seleccionaron como fuente de partida 4 RS que permitieron restringir la búsqueda a aquellos estudios posteriores a las fechas de búsqueda de las mismas: febrero 2017 para REBOA preventiva en casos de EAP y mayo 2021 para REBOA terapéutica. Aplicando todos los criterios de cribado se seleccionaron, 6 estudios individuales posteriores a las revisiones mencionadas y uno más con análisis coste-utilidad. CONCLUSIONES: Reboa Terapéutica: La REBOA terapéutica resulta efectiva en la reducción de mortalidad a las 24 horas cuando se compara con toracotomía resucitativa (OR= 0,26; IC95%: 0,20 ­ 0,34). La certeza de la evidencia se valoró como baja. En general REBOA permite reducir la mortalidad hospitalaria respecto a cualquier comparador (OR= 0,90; IC95%: 0,81 ­ 0,99) (certeza de la evidencia muy baja). Especialmente en la comparación con TR (OR= 0,30; IC95%: 0,26 ­ 0,35), la certeza de la evidencia se valoró como moderada. REBOA también mejora la presión arterial sistólica tras la oclusión más que cualquier comparador (DM= 41,03 mmHg; IC95%: 36,77 ­ 45,29). La certeza de la evidencia se valoró como baja. REBOA es menos segura que sus comparadores en cuanto a amputación de extremidades inferiores, daño renal agudo, paraplejia, con una certeza de la evidencia baja y daño pulmonar agudo con una certeza de la evidencia calificada como muy baja. REBOA no resultaría eficiente según el único estudio identificado que se enmarca en el contexto del Reino Unido y que compara con toracotomía resucitativa. Reboa Preventiva: REBOA reduce el número de histerectomías cuando se utiliza como medida preventiva en partos de mujeres con espectro de acretismo placentario (EAP) (OR= 0,21; IC95%: 0,08 ­ 0,53). La certeza de la evidencia fue calificada como baja. La Reboa: preventiva también permite reducir el número de mujeres ingresadas en UCI (OR= 0,18; IC95%: 0,08 ­ 0,42) (certeza de la evidencia muy baja). Del mismo modo REBOA preventiva permite reducir las necesidades de transfusión y la duración de las intervenciones quirúrgicas de mujeres con EAP (certeza de la evidencia muy baja). REBOA preventiva no presenta más efectos adversos o complicaciones que sus comparadores (certeza de la evidencia muy baja).

INTRODUCTION: Traumatic pathology is among the 5 leading causes of mortality, of which traumatic critical haemorrhage (TCH) is the main cause of avoidable death after trauma, accounting for 50% of deaths in the first 24 hours. According to the RETRAUCI database, approximately 6% of the patients admitted to the ICU of Spanish hospitals for trauma present TCH, with a hospital mortality of 35%. Bearing in mind that this mortality refers only to patients admitted to the ICU, it is very likely that the real mortality of TCH is much higher if the data on deaths outside the hospital or in the emergency department are included. Placental accreta spectrum disorder (PAD) is a complex obstetric complication associated with high maternal morbidity. It is a relatively new disorder of placentation, resulting from damage to the endometrial-myometrial interface of the uterine wall. PAD occurs in approximately 1 in 1000 deliveries. These figures vary widely, probably due to the definition of the study population, depending on which may range from 0.04 to 0.9%. PAP accounts for 23% of peripartum hysterectomies. The REBOA device (Resuscitative Endovascular Balloon Aortic Occlusion) consists of a catheter with a balloon and delivery sheath. Placement is by insertion into the femoral artery. Once the balloon of the REBOA catheter is inflated proximal to the lesion, an arterial blockage is created to prevent bleeding and maintain minimal blood supply to the brain, heart and lungs for the time necessary for the patient to receive adequate care. When used properly by experienced professionals, REBOA can improve outcomes for the subgroup of patients with the most severe injuries and extensive bleeding. Risks of REBOA include total visceral ischaemia, lower limb loss, exacerbation of traumatic brain injury, spinal cord ischaemia, rapid proximal blood loss and reperfusion injury effect. In the case of PAD, REBOA is an alternative preventive technique and provides a more proximal occlusion. This technique has also been used as an adjunct to conservative surgery and has the advantage of additional blockage of the placental supply from the external iliac arteries, as well as stopping flow in the middle sacral, lower lumbar and, in some cases, the inferior mesenteric artery. REBOA is inserted under fluoroscopic guidance prior to delivery. It is usually placed below the origin of the renal arteries to avoid ischaemia of the kidneys or abdominal viscera. The balloon would be inflated after delivery to prevent haemorrhage. In Spain, the REBOA technique is increasingly being used in hospitals specialising in trauma surgery and in the treatment of patients with severe injuries, and has also begun to be used preventively in the delivery of women with PAD. OBJECTIVE: To determine the safety, effectiveness and efficiency of the REBOA technique in patients with abdominal, retroperitoneal and pelvic haemorrhage or with PAD. METHODOLOGY: A systematic review of the available scientific literature on the effectiveness, safety and cost-effectiveness of REBOA in patients with traumatic abdomino-pelvic haemorrhage (therapeutic REBOA) or with PAD (preventive REBOA) was carried out. RESULTS: The SR carried out yielded 219 study references, excluding duplicates. Of these, 4 SR were selected as a starting source, which allowed us to restrict the search to those studies after their search dates: February 2017 for preventive REBOA in cases of PAD and May 2021 for therapeutic REBOA. Applying all the screening criteria, 6 individual studies were selected after the aforementioned reviews and one more with cost-utility analysis. CONCLUSIONS: Therapeutic Reboa: Therapeutic REBOA is effective in reducing 24-hour mortality when compared to resuscitative thoracotomy (OR= 0.26; 95%CI: 0.20 ­ 0.34). The certainty of the evidence was assessed as low. Overall, REBOA reduces in-hospital mortality compared to any comparator (OR= 0.90; 95%CI: 0.81 ­ 0.99) (very low certainty of evidence). Especially in the comparison with TR (OR= 0.30; 95%CI: 0.26 ­ 0.35), the certainty of evidence was assessed as moderate. REBOA also improves systolic blood pressure after occlusion more than any comparator (MD= 41.03 mmHg; 95% CI: 36.77 ­ 45.29). The certainty of the evidence was assessed as low. REBOA is less safe than its comparators in terms of lower limb amputation, acute kidney damage, paraplegia with a certainty of evidence rated as low. and acute lung damage, with a certainty of evidence rated as very low. REBOA wouldn't be efficient according to the only identified study in the UK context comparing with TR. Preventive Reboa: REBOA reduces the number of hysterectomies when used as a preventive measure in deliveries of women with PAD (OR= 0.21; 95%CI: 0.08 ­ 0.53). Certainty of evidence rated as low. Preventive REBOA also reduces the number of women admitted to the ICU (OR= 0.18; 95%CI: 0.08 ­ 0.42) (certainty of evidence very low). Similarly, preventive REBOA reduces transfusion requirements and the duration of surgery for women with PAD (certainty of evidence very low). Preventive REBOA has no more adverse effects or complications than its comparators (certainty of evidence very low).

Influence of blood hemodynamics on the treatment outcomes of limited fluid resuscitation in emergency patients with traumatic hemorrhagic shock.

OBJECTIVES: Traumatic hemorrhagic shock is a major death-related factor contributing to mortality in emergencies and can be effectively handled by the Limited Fluid Resuscitation (LFR) method. In the current investigation, the authors analyzed the influence of different administrating blood pressure on the treatment outcomes of LFR. METHODS: 276 participants were enrolled in the current study retrospectively from January 2016 to December 2021 and were divided into three groups based on the administrating blood pressure of LFR. The difference among the three groups regarding serum levels of cytokines as well as blood hemodynamics parameters was analyzed. RESULTS: The results showed after the T2 stage treatment, cytokine levels in the three groups were all significantly influenced by different LFR strategies with medium MAP showing the strongest effects on the expression of all cytokine genes. Moreover, the MAP value was in positive correlation with IL-6, IL-10, and TNF-α levels, but showed no clear relation with IL-4 level in all three groups. Regarding the effects on hemodynamics parameters, the levels of CVP, CO, and CI were slightly increased by the different LFR administrating strategies, and the effect of medium and high MAP was statistically stronger than that of low MAP. CONCLUSION: The present results showed that LFR would influence serum inflammatory levels by improving blood hemodynamics parameters. Medium MAP showed the strongest improving effects with the least side effects, which can be employed as the optimal administrating strategy for LFR in the future.

Perspectives on peripheral perfusion assessment.

PURPOSE OF REVIEW: The ANDROMEDA-SHOCK trial positioned capillary refill time (CRT) assessment as a novel resuscitation target for septic shock.The purpose of this article is to summarize pathophysiological determinants of CRT, review new technical developments on peripheral perfusion assessment, and explore recent evidence on the role of CRT monitoring in septic shock and other critical conditions. RECENT FINDINGS: A growing body of evidence supports the role of peripheral perfusion assessment as a warning and prognostic signal in a variety of clinical conditions among severely ill patients. Recent physiological studies demonstrated a rapid improvement of CRT after a single fluid bolus or a passive leg raising maneuver, a fact which may have diagnostic and therapeutic implications. Moreover, a couple of posthoc analyses of ANDROMEDA-SHOCK trial, reinforce that a normal CRT at the start of septic shock resuscitation, or its rapid normalization, thereafter may be associated with significant better outcomes. SUMMARY: Recent data confirm the relevance of peripheral perfusion assessment in septic shock and other conditions in critically ill patients. Future studies should confirm these findings, and test the potential contribution of technological devices to assess peripheral perfusion.

Predictors of Massive Transfusion Protocol Initiation Among Trauma Patients Transported From the Scene Via Flight Emergency Management Services.

OBJECTIVE: Early identification of the subset of trauma patients with acute hemorrhage who require resuscitation via massive transfusion protocol (MTP) initiation is vital because such identification can ensure the availability of resuscitation products immediately upon hospital arrival and result in improved clinical outcomes, including reduced mortality. However, there are currently few studies on the predictors of MTP in the unique setting of flight transport. METHODS: This was a retrospective study of adult trauma patients transported from the scene via flight to 6 trauma centers between March 1, 2019, and January 21, 2021. Patients were included if they had emergency medical service vitals documented. The variables collected included demographics, comorbidities, cause of injury, body regions injured, in-flight treatments, and transport vitals. The primary outcome was MTP initiated by the receiving hospital. RESULTS: A total of 212 patients were included, of whom 16 (8%) had MTP initiated. During flight transport, 24 (11%) received whole blood, 9 (4%) received packed red blood cells, 11 (5%) had a tourniquet placed, and 5 (2%) received tranexamic acid. In adjusted analyses, receiving whole blood during transport (odds ratio [OR] = 8.52, P < .01), systolic blood pressure ≤ 90 mm Hg (OR = 8.07, P < .01), and a Glasgow Coma Scale score < 13 (OR = 8.38, P < .01) were independently associated with MTP. CONCLUSIONS: This retrospective cohort study showed that 3 factors readily available in the flight setting-receipt of whole blood, systolic blood pressure, and Glasgow Coma Scale score-are strong predictors of MTP at the receiving facility, particularly when considered in aggregate.

Effects of N-acetylcysteine on the inflammatory response and bacterial translocation in a model of intestinal obstruction and ischemia in rats.

PURPOSE: To evaluate effect of N-acetylcysteine (NAC) associated with Ringer lactate or hypertonic saline in inflammation and bacterial translocation on experimental intestinal obstruction (IO). METHODS: Wistar rats was subjected to IO. Six or 24 hours after, rats were subjected to enterectomy and fluid resuscitation: IO, RL (subjected to the same procedures but with fluid resuscitation using Ringer's lactate solution); RLNAC (added NAC to Ringer's solution); and HSNAC (surgical procedure + fluid reposition with 7.5% hypertonic saline and NAC). After 24 h, tissues were collected to cytokines, bacterial translocation, and histological assessments. RESULTS: In kidney, interleukin-1beta (IL-1beta) was lower in the groups with fluid resuscitation compared to IO group. The RLNAC showed lower levels compared to the RL. Interleukin-6 (IL-6), interleukin-10 (IL-10), tumor necrosis factor-alpha (TNF-alpha), and (IFN-gamma) were lower in the treatment groups than in IO. In lung, IL-1beta and IL-6 were lower in RLNAC compared to IO. IL-10 was lower in RL, RLNAC and HSNAC compared to IO. TNF-alpha was higher in HSNAC compared to both RL and RLNAC. Bacterial translocation was observed in all animals of IO group. In kidneys, inflammation and congestion degrees were lower in HSNAC compared to RL. In lungs, inflammation levels were higher in RLNAC compared with the sham group. CONCLUSIONS: The data indicates that NAC associated with RL can promote a decrease in the inflammatory process in the kidneys and lungs in rats, following intestinal obstruction and ischemia in rats.

Exploring the relationship between capillary refill time, skin blood flow and microcirculatory reactivity during early resuscitation of patients with septic shock: a pilot study.

Capillary refill time (CRT), a costless and widely available tool, has emerged as a promising target to guide septic shock resuscitation. However, it has yet to gain universal acceptance due to its potential inter-observer variability. Standardization of CRT assessment may minimize this problem, but few studies have compared this approach with techniques that directly assess skin blood flow (SBF). Our objective was to determine if an abnormal CRT is associated with impaired SBF and microvascular reactivity in early septic shock patients. Twelve septic shock patients were subjected to multimodal perfusion and hemodynamic monitoring for 24 h. Three time-points (0, 1, and 24 h) were registered for each patient. SBF was measured by laser doppler. We performed a baseline SBF measurement and two microvascular reactivity tests: one with a thermal challenge at 44 °C and other with a vascular occlusion test. Ten healthy volunteers were evaluated to obtain reference values. The patients (median age 70 years) exhibited a 28-day mortality of 50%. Baseline CRT was 3.3 [2.7-7.3] seconds. In pooled data analysis, abnormal CRT presented a significantly lower SBF when compared to normal CRT [44 (13.3-80.3) vs 193.2 (99.4-285) APU, p = 0.0001]. CRT was strongly associated with SBF (R2 0.76, p < 0.0001). An abnormal CRT also was associated with impaired thermal challenge and vascular occlusion tests. Abnormal CRT values observed during early septic shock resuscitation are associated with impaired skin blood flow, and abnormal skin microvascular reactivity. Future studies should confirm these results.

Resuscitation with Intact Cord Versus Clamped Cord in Late Preterm and Term Neonates: A Randomized Controlled Trial.

OBJECTIVE: To compare the effect of intact cord versus clamped cord resuscitation on the physiologic transition of neonates receiving positive-pressure ventilation (PPV) at birth. STUDY DESIGN: This open-label, parallel-group, randomized controlled superiority trial was conducted in a tertiary care hospital in India. Neonates born at ≥34 weeks of gestation after a complicated pregnancy or labor were randomized just before birth to receive resuscitation according to the Neonatal Resuscitation Program algorithm with either an intact cord (intact cord resuscitation group) or after early cord clamping (early cord clamping resuscitation group). The allocated study intervention was administered if the neonate needed PPV at birth. The primary outcome was expanded Apgar score at 5 minutes after birth. RESULTS: Birth weight, gestational age, and the incidence of pregnancy complications were similar in the 2 study groups. The proportion of neonates who received PPV was lower in the intact cord resuscitation group (28.7% vs 36.5%, P = .05; relative risk, 0.79; 95% CI, 0.61-1.01). Among neonates who received PPV, the expanded Apgar score at 5 minutes was significantly higher in the intact cord resuscitation group (median, 15 [IQR, 14-15] vs 14 [IQR, 13-15]; P < .001). The expanded Apgar score at 10 minutes, Apgar scores at 5 and 10 minutes, and oxygen saturation at 1, 5, and 10 minutes were also higher in the intact cord resuscitation group. CONCLUSION: In late preterm and term neonates, resuscitation with an intact cord results in better postnatal physiologic transition than the standard practice of resuscitation after immediate cord clamping. TRIAL REGISTRATION: Clinical Trial Registry of India (www.ctri.nic.in); trial registration no. CTRI/2020/02/023379.

Effect of the Helping Babies Breathe Program on Newborn Outcomes: Systematic Review and Meta-Analysis.

Background and objectives: In low- and middle-income countries, the leading cause of neonatal mortality is perinatal asphyxia. Training in neonatal resuscitation has been shown to decrease this cause of mortality. The program "Helping Babies Breathe" (HBB) is a program to teach basic neonatal resuscitation focused on countries and areas with limited economic resources. The aim of the study was to determine the effect of the implementation of the HBB program on newborn outcomes: mortality and morbidity. Material and Methods: A systematic review was carried out on observational studies and clinical trials that reported the effect of the implementation in low- and middle-income countries of the HBB program on neonatal mortality and morbidity. We carried out a meta-analysis of the extracted data. Random-effect models were used to evaluate heterogeneity, using the Cochrane Q and I2 tests, and stratified analyses were performed by age and type of outcome to determine the sources of heterogeneity. Results: Eleven studies were identified. The implementation of the program includes educational strategies focused on the training of doctors, nurses, midwives, and students of health professions. The poled results showed a decrease in overall mortality (OR 0.67; 95% CI 0.57, 0.80), intrapartum stillbirth mortality (OR 0.62; 95% CI 0.51, 0.75), and first-day mortality (OR 0.70; 95% IC 0.64, 0.77). High heterogeneity was found, which was partly explained by differences in the gestational age of the participants. Conclusions: The implementation of the program HBB in low- and medium-income countries has a significant impact on reducing early neonatal mortality.

Resuscitative endovascular balloon occlusion of the aorta in civilian pre-hospital care: a systematic review of the literature.

BACKGROUND: Resuscitative endovascular balloon occlusion of the aorta (REBOA) is a damage control tool with a potential role in the hemodynamic resuscitation of severely ill patients in the civilian pre-hospital setting. REBOA ensures blood flow to vital organs by early proximal control of the source of bleeding. However, there is no consensus on the use of REBOA in the pre-hospital setting. This article aims to perform a systematic review of the literature about the feasibility, survival, indications, complications, and potential candidates for civilian pre-hospital REBOA. METHODS: A literature search was conducted using Medline, EMBASE, LILACS and Web of Science databases. Primary outcome variables included overall survival and feasibility. Secondary outcome variables included complications and potential candidates for endovascular occlusion. RESULTS: The search identified 8 articles. Five studies described the use of REBOA in pre-hospital settings, reporting a total of 47 patients in whom the procedure was attempted. Pre-hospital REBOA was feasible in 68-100% of trauma patients and 100% of non-traumatic patients with cardiac arrest. Survival rates and complications varied widely. Pre-hospital REBOA requires a coordinated and integrated emergency health care system with a well-trained and equipped team. The remaining three studies performed a retrospective analysis identifying 784 potential REBOA candidates. CONCLUSIONS: Pre-hospital REBOA could be a feasible intervention for a significant portion of severely ill patients in the civilian setting. However, the evidence is limited. The impact of pre-hospital REBOA should be assessed in future studies.

Trauma video review outperforms prospective real-time data collection for study of resuscitative thoracotomy.

BACKGROUND: A major challenge in the study of high-impact, low-frequency procedures in trauma is the lack of accurate data for time-sensitive processes of care. Trauma video review offers a possible solution, allowing investigators to collect extremely granular time-stamped data. Using resuscitative thoracotomy as a model, we compared data collected using review of audiovisual recordings to data prospectively collected in real time with the hypothesis that data collected using video review would be subject to less missingness and bias. METHODS: We conducted a prospective cohort study of patients undergoing resuscitative thoracotomy at a single urban academic level 1 trauma center. Key data on the timing and completion of procedural milestones of resuscitative thoracotomy were collected using video review and prospective collection. We used McNemar's test to compare proportions of missing data between the 2 methods and calculated bias in time measurements for prospective collection with respect to video review. Statistical analyses were performed using Stata v. 15.0 (College Station, TX). RESULTS: We included 51 subjects (88% Black, 82% male, 90% injured by gunshot wounds) over the study period. Missingness in resuscitative thoracotomy procedural milestone time measurements ranged from 34% to 63% for prospective collection and 0 to 8% for video review and was less missing for video review for all key variables (P < .001). When not missing, bias in data collected by prospective collection was 10% to 43% compared with data collected by video review. CONCLUSIONS: The data collected using video review have less missingness and bias than prospective collection data collected by trained research assistants. Audiovisual recording should be the gold standard for data collection for the study of time-sensitive processes of care in resuscitation.

Hemodynamic phenotype-based, capillary refill time-targeted resuscitation in early septic shock: The ANDROMEDA-SHOCK-2 Randomized Clinical Trial study protocol. / Ressuscitação direcionada ao tempo de enchimento capilar baseada em fenótipo hemodinâmico no choque séptico precoce: protocolo de estudo do ensaio clínico randomizado ANDROMEDA-SHOCK-2.

BACKGROUND: Early reversion of sepsis-induced tissue hypoperfusion is essential for survival in septic shock. However, consensus regarding the best initial resuscitation strategy is lacking given that interventions designed for the entire population with septic shock might produce unnecessary fluid administration. This article reports the rationale, study design and analysis plan of the ANDROMEDA-2 study, which aims to determine whether a peripheral perfusion-guided strategy consisting of capillary refill time-targeted resuscitation based on clinical and hemodynamic phenotypes is associated with a decrease in a composite outcome of mortality, time to organ support cessation, and hospital length of stay compared to standard care in patients with early (< 4 hours of diagnosis) septic shock. METHODS: The ANDROMEDA-2 study is a multicenter, multinational randomized controlled trial. In the intervention group, capillary refill time will be measured hourly for 6 hours. If abnormal, patients will enter an algorithm starting with pulse pressure assessment. Patients with pulse pressure less than 40mmHg will be tested for fluid responsiveness and receive fluids accordingly. In patients with pulse pressure > 40mmHg, norepinephrine will be titrated to maintain diastolic arterial pressure > 50mmHg. Patients who fail to normalize capillary refill time after the previous steps will be subjected to critical care echocardiography for cardiac dysfunction evaluation and subsequent management. Finally, vasopressor and inodilator tests will be performed to further optimize perfusion. A sample size of 1,500 patients will provide 88% power to demonstrate superiority of the capillary refill time-targeted strategy. CONCLUSIONS: If hemodynamic phenotype-based, capillary refill time-targeted resuscitation demonstrates to be a superior strategy, care processes in septic shock resuscitation can be optimized with bedside tools.

INTRODUçÃO: A reversão precoce da hipoperfusão tecidual induzida é essencial para a sobrevida no choque séptico. No entanto, falta consenso sobre a melhor estratégia de ressuscitação inicial, uma vez que intervenções destinadas a toda a população com choque séptico podem produzir administração desnecessária de líquidos. Este artigo relata a justificativa, o delineamento e o plano de análise do estudo ANDROMEDA-2, que visa determinar se uma estratégia guiada por perfusão periférica, que consiste na ressuscitação guiada pelo tempo de enchimento capilar com base em fenótipos clínicos e hemodinâmicos, está associada a uma diminuição no desfecho composto de mortalidade, tempo até a interrupção ao suporte de órgãos e tempo de internação em comparação com o atendimento padrão em pacientes com choque séptico precoce (< 4 horas do diagnóstico). METÓDOS: O estudo ANDROMEDA-2 é um ensaio clínico randomizado controlado multinacional e multicêntrico. No grupo de intervenção, o tempo de enchimento capilar será medido a cada hora, durante 6 horas. Se estiver anormal, os pacientes serão alocados em um algoritmo, começando com a avaliação da pressão de pulso. Pacientes com pressão de pulso inferior a 40mmHg serão testados quanto à capacidade de resposta a líquidos e receberão líquidos de acordo. Em pacientes com pressão de pulso > 40mmHg, norepinefrina será titulada para manter a pressão arterial diastólica > 50mmHg. Os pacientes que não normalizarem o tempo de enchimento capilar após as etapas anteriores serão submetidos à ecocardiografia de cuidados intensivos para avaliação da disfunção cardíaca e posterior manejo. Por fim, serão realizados testes com vasopressores e inodilatadores para otimizar ainda mais a perfusão. Um tamanho de amostra de 1.500 pacientes fornecerá 88% de poder para demonstrar a superioridade da estratégia direcionada ao tempo de enchimento capilar. CONCLUSÃO: Se for demonstrado que o direcionamento ao tempo de enchimento capilar é uma estratégia melhor, os processos de atendimento na ressuscitação do choque séptico podem ser otimizados com ferramentas usadas à beira do leito.

Translating Neonatal Resuscitation Guidelines Into Practice in Brazil.

BACKGROUND AND OBJECTIVES: The Brazilian Neonatal Resuscitation Program releases guidelines based on local interpretation of international consensus on science and treatment recommendations. We aimed to analyze whether guidelines for preterm newborns were applied to practice in the 20 Brazilian Network on Neonatal Research centers of this middle-income country. METHODS: Prospectively collected data from 2014 to 2020 were analyzed for 8514 infants born at 230/7 to 316/7 weeks' gestation. The frequency of procedures was evaluated by gestational age (GA) category, including use of a thermal care bundle, positive pressure ventilation (PPV), PPV with a T-piece resuscitator, maximum fraction of inspired oxygen (Fio2) concentration during PPV, tracheal intubation, chest compressions and medications, and use of continuous positive airway pressure in the delivery room. Logistic regression, adjusted by center and year, was used to estimate the probability of receiving recommended treatment. RESULTS: For 3644 infants 23 to 27 weeks' GA and 4870 infants 28 to 31 weeks' GA, respectively, the probability of receiving care consistent with guidelines per year increased, including thermal care (odds ratio [OR], 1.52 [95% confidence interval (CI) 1.44-1.61] and 1.45 [1.38-1.52]) and PPV with a T-piece (OR, 1.45 [95% CI 1.37-1.55] and 1.41 [1.32-1.51]). The probability of receiving PPV with Fio2 1.00 decreased equally in both GA groups (OR, 0.89; 95% CI, 0.86-0.93). CONCLUSIONS: Between 2014 and 2020, the resuscitation guidelines for newborns <32 weeks' GA on thermal care, PPV with a T-piece resuscitator, and decreased use of Fio2 1.00 were translated into clinical practice.

Transfusion Ratios and Deficits in Injured Children With Life-Threatening Bleeding.

OBJECTIVES: To assess the impact of plasma and platelet ratios and deficits in injured children with life-threatening bleeding. DESIGN: Secondary analysis of the MAssive Transfusion epidemiology and outcomes In Children study dataset, a prospective observational study of children with life-threatening bleeding events. SETTING: Twenty-four childrens hospitals in the United States, Canada, and Italy. PATIENTS: Injured children 0-17 years old who received greater than 40 mL/kg total blood products over 6 hours or were transfused under activation of massive transfusion protocol. INTERVENTION/EXPOSURE: Weight-adjusted blood product volumes received during the bleeding event were recorded. Plasma:RBC ratio (plasma/RBC weight-adjusted volume in mL/kg) and platelet:RBC ratio (platelet/RBC weight-adjusted volume in mL/kg) were analyzed. Plasma deficit was calculated as RBC mL/kg - plasma mL/kg; platelet deficit was calculated as RBC mL/kg - platelet mL/kg. MEASUREMENTS AND MAIN RESULTS: Of 191 patients analyzed, median (interquartile range) age was 10 years (5-15 yr), 61% were male, 61% blunt mechanism, and median (interquartile range) Injury Severity Score was 29 (24-38). After adjusting for Pediatric Risk of Mortality score, cardiac arrest, use of vasoactive medications, and blunt mechanism, a high plasma:RBC ratio (> 1:2) was associated with improved 6-hour survival compared with a low plasma:RBC ratio (odds ratio [95% CI] = 0.12 [0.03-0.52]; p = 0.004). Platelet:RBC ratio was not associated with survival. After adjusting for age, Pediatric Risk of Mortality score, cardiac arrest, and mechanism of injury, 6-hour and 24-hour mortality were increased in children with greater plasma deficits (10% and 20% increased odds of mortality for every 10 mL/kg plasma deficit at 6 hr [p = 0.04] and 24 hr [p = 0.01], respectively); 24-hour mortality was increased in children with greater platelet deficits (10% increased odds of 24-hr mortality for every 10 mL/kg platelet deficit [p = 0.02)]). CONCLUSIONS: In injured children, balanced resuscitation may improve early survival according to this hypothesis generating study. Multicenter clinical trials are needed to assess whether clinicians should target ratios and deficits as optimal pediatric hemostatic resuscitation practice.

The role of direct peritoneal resuscitation in the treatment of hemorrhagic shock after trauma and in emergency acute care surgery: a systematic review.

PURPOSE: Direct peritoneal resuscitation (DPR) has been used to help preserve microcirculation by reversing vasoconstriction and hypoperfusion associated with the pathophysiological process of shock, which can occur despite appropriate intravenous resuscitation. This approach depends on infusing a hyperosmolar solution intraperitoneally via a percutaneous catheter with the tip ending near the pelvis or the root of the mesentery. The abdomen is usually left open with a negative pressure abdominal dressing to continuously evacuate the infused dialysate. Hypertonicity of the solution triggers visceral vasodilation to help maintain blood flow, even during shock, and is also associated with reduced local inflammatory cytokines and other mediators, preservation of endothelial cell function, and mitigation of organ edema and necrosis. It also has a direct effect on liver perfusion and edema, more rapidly corrects electrolyte abnormalities compared to intravenous resuscitation alone, and may requireless intravenous fluid to stabilize blood pressure, all of which shortens the time required to close patients' abdomen. METHODS: An online query using the search term "direct peritoneal resuscitation" was carried out in PubMed, MEDLINE and SciELO, limited to publications indexed from January 2014 to June 2020. Of the 20 articles returned, full text was able to be obtained for 19. A manual review of included articles' references was resulted in the addition of 1 article, for a total of 20 included articles. RESULTS: The 20 articles were comprised of 15 animal studies, 4 clinical studies,and 1 expert opinion. The benefits include both local and possibly systemic effects on perfusion, hypoxia, acidosis, and inflammation, and are associated with improved outcomes and reduced complications. CONCLUSION: DPR shows promise in patients with hemorrhagic shock, septic shock, and other conditions resulting in an open abdomen after damage control laparotomy.

Revisión sistemática y metaanálisis sobre eficacia de las drogas vasoactivas en el shock hemorrágico en animales / Systematic review and meta-analysis on the efficacy of vasoactive drugs in hemorrhagic shock in animals

The objective of this review was to evalúate the efficacy of the use of vasoactive drugs in the initial resuscitation of hemorrhagic shock in animals. The search was developed using the databases: Cochrane Central Register of Controlled Trials, PUBMED, MEDLINE, EMBASE, the database was also included: Clinical Trial.gov; no date restriction of publication or language. We included randomized controlled clinical trials in animals that compared the use of vasoactive drugs with any other resuscitation strategy for hemorrhagic shock. The analysis was developed using of review manager version 5.4, with the random effects model and the Mantel Haenszel method for dichotomous data. Statistical heterogeneity was evaluated with the statisgraph I. The strength of evidence was assessed for each outcome according to the statements of the working group for the classification of the quality of the evidence (GRADE). 18 trials (n = 533 participant) were included in this meta-analysis. Compared with control, vasopressors were associated with lower relative risk of mortality during initial resuscitation from hae- morrhagic shock, with an overall risk estimate of 0.53 (0.39, 0.71) 95% confidence interval. There is evidence of the efficacy of vasopressors in resuscitation hemorrhagic shock in animals, this is of moderate to low quality; Therefore, it is necessary to develop and implement randomized clinical trials that allow an evaluation of the efficacy and safety of these drugs in humans for their use systematically in patients with hemorrhagic shock.

El objetivo de esta revisión fue evaluar la eficacia del uso de drogas vasoactivas en la resucitación inicial del hemorrágico en animales. La búsqueda fue desarrollada usando las bases de datos: Cochrane Central Register of Controlled Trials, PUBMED, MEDLINE, EMBASE, fue incluida además la base de datos: Clinical Trial.gov; sin restricción por fecha de publicación o idioma. Se incluyeron ensayos clínicos controlados y aleatorizados en animales que compararon el uso de drogas vasoactivas con cualquier otra estrategia de resucitación del hemorrágico. El análisis fue desarrollado con el uso de review manager versión 5.4, con el modelo de efectos aleatorios y el método de Mantel Haenszel para datos dicotómicos. Heterogeneidad estadística fue evaluada con el estadígrafo I. La fuerza de la evidencia fue evaluada para cada resultado acorde a las declaraciones del grupo de trabajo para la clasificación de la calidad de la evidencia (GRADE). 18 ensayos (n = 533 participante) fueron incluidos en este metaanálisis. Comparado con el control, los vasopresores fueron asociados con menor riesgo relativo de mortalidad durante la reanimación inicial del hemorrágico, con una estimación global del riesgo de 0,53 (0,39, 0,71) intervalo de confianza de 95%. Existe evidencia de la eficacia de los vasopresores en la reanimación inicial del hemorrágico en animales, esta es de calidad moderada a baja; por lo que, es necesario desarrollar e implementar ensayos clínicos aleatorizados que permitan una evaluación de la eficacia y seguridad de estas drogas en humanos para su uso de manera sistemática en pacientes con hemorrágico.

Sustained Inflation Versus Intermittent Positive Pressure Ventilation for Preterm Infants at Birth: Respiratory Function and Vital Sign Measurements.

OBJECTIVE: To characterize respiratory function monitor (RFM) measurements of sustained inflations and intermittent positive pressure ventilation (IPPV) delivered noninvasively to infants in the Sustained Aeration of Infant Lungs (SAIL) trial and to compare vital sign measurements between treatment arms. STUDY DESIGN: We analyzed RFM data from SAIL participants at 5 trial sites. We assessed tidal volumes, rates of airway obstruction, and mask leak among infants allocated to sustained inflations and IPPV, and we compared pulse rate and oxygen saturation measurements between treatment groups. RESULTS: Among 70 SAIL participants (36 sustained inflations, 34 IPPV) with RFM measurements, 40 (57%) were spontaneously breathing prior to the randomized intervention. The median expiratory tidal volume of sustained inflations administered was 5.3 mL/kg (IQR 1.1-9.2). Significant mask leak occurred in 15% and airway obstruction occurred during 17% of sustained inflations. Among 34 control infants, the median expiratory tidal volume of IPPV inflations was 4.3 mL/kg (IQR 1.3-6.6). Mask leak was present in 3%, and airway obstruction was present in 17% of IPPV inflations. There were no significant differences in pulse rate or oxygen saturation measurements between groups at any point during resuscitation. CONCLUSION: Expiratory tidal volumes of sustained inflations and IPPV inflations administered in the SAIL trial were highly variable in both treatment arms. Vital sign values were similar between groups throughout resuscitation. Sustained inflation as operationalized in the SAIL trial was not superior to IPPV to promote lung aeration after birth in this study subgroup. TRIAL REGISTRATION: Clinicaltrials.gov: NCT02139800.

Implementación de balón de resucitación aórtico endovascular (REBOA) para el control de hemorragia no compresible de torso / Implementation of the resuscitative endovascular balloon occlusion of the aorta (REBOA) for the control of non-compressible torso hemorrhage

Resumen Introducción: La hemorragia no compresible de torso, actualmente tiene una alta morbimortalidad aún en los centros de referencia más especializados. El REBOA es una herramienta emergente que se utiliza como control hemostático precoz en este tipo de pacientes. Caso Clínico: Presentamos el caso de una paciente femenina de 25 años que sufre un trauma pélvico grave tras caer de altura. Ingresa hemodinámicamente inestable por lo cual se activa protocolo de transfusión masiva y realiza acceso arterial femoral común derecho. Al presentar una respuesta transitoria a la reanimación, se instala balón de REBOA en zona 3, logrando aumentar presión sistólica hasta 130 mmHg, trasladando posteriormente a quirófano. Se realiza packing pélvico preperitoneal y fijación externa, desinflando el balón después de 29 min en zona 3. La paciente sale a unidad de cuidados intensivos sin drogas vasoactivas, para completar cirugía a las 48 h y fijación definitiva 6 días después. La paciente evoluciona en buenas condiciones generales.

Introduction: Non-compressible torso hemorrhage currently has a high morbidity and mortality even in the most specialized referral centers. REBOA is an emerging tool that is used as early hemostatic control in this type of patient. Clinical Case: We present the case of a 25-year-old female patient who suffers severe pelvic trauma after falling from a height. He was admitted hemodynamically unstable, for which a massive transfusion protocol was activated and a right common femoral arterial access was performed. After presenting a transient response to resuscitation, a REBOA balloon was installed in zone 3, increasing systolic pressure up to 130 mmHg, later transferring to the operating room. Preperitoneal pelvic packing and external fixation were performed, deflating the balloon after 29 minutes in zone 3. The patient left the intensive care unit without vasoactive drugs, to complete surgery 48 hours later and definitive fixation 6 days later. The patient evolves in good general condition.