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1.
Crit Care Med ; 52(7): e411-e412, 2024 Jul 01.
Article in English | MEDLINE | ID: mdl-38869402
2.
Transpl Int ; 37: 12791, 2024.
Article in English | MEDLINE | ID: mdl-38681973

ABSTRACT

Intensive Care to facilitate Organ Donation (ICOD) consists of the initiation or continuation of intensive care measures in patients with a devastating brain injury (DBI) in whom curative treatment is deemed futile and death by neurological criteria (DNC) is foreseen, to incorporate organ donation into their end-of-life plans. In this study we evaluate the outcomes of patients subject to ICOD and identify radiological and clinical factors associated with progression to DNC. In this first prospective multicenter study we tested by multivariate regression the association of clinical and radiological severity features with progression to DNC. Of the 194 patients, 144 (74.2%) patients fulfilled DNC after a median of 25 h (95% IQR: 17-44) from ICOD onset. Two patients (1%) shifted from ICOD to curative treatment, both were alive at discharge. Factors associated with progression to DNC included: age below 70 years, clinical score consistent with severe brain injury, instability, intracranial hemorrhage, midline shift ≥5 mm and certain types of brain herniation. Overall 151 (77.8%) patients progressed to organ donation. Based on these results, we conclude that ICOD is a beneficial and efficient practice that can contribute to the pool of deceased donors.


Subject(s)
Critical Care , Tissue and Organ Procurement , Humans , Prospective Studies , Male , Female , Tissue and Organ Procurement/methods , Middle Aged , Aged , Spain , Adult , Brain Injuries , Brain Death , Intensive Care Units
3.
Crit Care Med ; 52(5): 786-797, 2024 05 01.
Article in English | MEDLINE | ID: mdl-38259143

ABSTRACT

OBJECTIVES: Our aims were to explore current intubation practices in Spanish ICUs to determine the incidence and risk factors of peri-intubation complications (primary outcome measure: major adverse events), the rate and factors associated with first-pass success, and their impact on mortality as well as the changes of the intubation procedure observed in the COVID-19 pandemic. DESIGN: Prospective, observational, and cohort study. SETTING: Forty-three Spanish ICU. PATIENTS: A total of 1837 critically ill adult patients undergoing tracheal intubation. The enrollment period was six months (selected by each center from April 16, 2019, to October 31, 2020). INTERVENTIONS: None. MEASUREMENT AND MAIN RESULTS: At least one major adverse peri-intubation event occurred in 40.4 % of the patients (973 major adverse events were registered) the most frequent being hemodynamic instability (26.5%) and severe hypoxemia (20.3%). The multivariate analysis identified seven variables independently associated with a major adverse event whereas the use of neuromuscular blocking agents (NMBAs) was associated with reduced odds of major adverse events. Intubation on the first attempt was achieved in 70.8% of the patients. The use of videolaryngoscopy at the first attempt was the only protective factor (odds ratio 0.43; 95% CI, 0.28-0.66; p < 0.001) for first-attempt intubation failure. During the COVID-19 pandemic, the use of videolaryngoscopy and NMBAs increased significantly. The occurrence of a major peri-intubation event was an independent risk factor for 28-day mortality. Cardiovascular collapse also posed a serious threat, constituting an independent predictor of death. CONCLUSIONS: A major adverse event occurred in up to 40% of the adults intubated in the ICU. Peri-intubation hemodynamic instability but not severe hypoxemia was identified as an independent predictor of death. The use of NMBAs was a protective factor for major adverse events, whereas the use of videolaringoscopy increases the first-pass success rate of intubation. Intubation practices changed during the COVID-19 pandemic.


Subject(s)
COVID-19 , Vascular Diseases , Adult , Humans , Prospective Studies , Cohort Studies , Critical Illness/therapy , Spain/epidemiology , Pandemics , Intubation, Intratracheal/adverse effects , Intubation, Intratracheal/methods , Hypoxia/epidemiology , Hypoxia/etiology , Vascular Diseases/etiology
4.
Arch Bronconeumol ; 59(4): 205-215, 2023 Apr.
Article in English, Spanish | MEDLINE | ID: mdl-36690515

ABSTRACT

INTRODUCTION: Critical COVID-19 survivors have a high risk of respiratory sequelae. Therefore, we aimed to identify key factors associated with altered lung function and CT scan abnormalities at a follow-up visit in a cohort of critical COVID-19 survivors. METHODS: Multicenter ambispective observational study in 52 Spanish intensive care units. Up to 1327 PCR-confirmed critical COVID-19 patients had sociodemographic, anthropometric, comorbidity and lifestyle characteristics collected at hospital admission; clinical and biological parameters throughout hospital stay; and, lung function and CT scan at a follow-up visit. RESULTS: The median [p25-p75] time from discharge to follow-up was 3.57 [2.77-4.92] months. Median age was 60 [53-67] years, 27.8% women. The mean (SD) percentage of predicted diffusing lung capacity for carbon monoxide (DLCO) at follow-up was 72.02 (18.33)% predicted, with 66% of patients having DLCO<80% and 24% having DLCO<60%. CT scan showed persistent pulmonary infiltrates, fibrotic lesions, and emphysema in 33%, 25% and 6% of patients, respectively. Key variables associated with DLCO<60% were chronic lung disease (CLD) (OR: 1.86 (1.18-2.92)), duration of invasive mechanical ventilation (IMV) (OR: 1.56 (1.37-1.77)), age (OR [per-1-SD] (95%CI): 1.39 (1.18-1.63)), urea (OR: 1.16 (0.97-1.39)) and estimated glomerular filtration rate at ICU admission (OR: 0.88 (0.73-1.06)). Bacterial pneumonia (1.62 (1.11-2.35)) and duration of ventilation (NIMV (1.23 (1.06-1.42), IMV (1.21 (1.01-1.45)) and prone positioning (1.17 (0.98-1.39)) were associated with fibrotic lesions. CONCLUSION: Age and CLD, reflecting patients' baseline vulnerability, and markers of COVID-19 severity, such as duration of IMV and renal failure, were key factors associated with impaired DLCO and CT abnormalities.


Subject(s)
COVID-19 , Pulmonary Emphysema , Humans , Female , Middle Aged , Male , Critical Illness , Follow-Up Studies , COVID-19/complications , Disease Progression , Lung/diagnostic imaging
5.
Eur Respir J ; 61(3)2023 03.
Article in English | MEDLINE | ID: mdl-36396142

ABSTRACT

BACKGROUND: The primary aim of our study was to investigate the association between intubation timing and hospital mortality in critically ill patients with coronavirus disease 2019 (COVID-19)-associated respiratory failure. We also analysed both the impact of such timing throughout the first four pandemic waves and the influence of prior noninvasive respiratory support on outcomes. METHODS: This is a secondary analysis of a multicentre, observational and prospective cohort study that included all consecutive patients undergoing invasive mechanical ventilation due to COVID-19 from across 58 Spanish intensive care units (ICUs) participating in the CIBERESUCICOVID project. The study period was between 29 February 2020 and 31 August 2021. Early intubation was defined as that occurring within the first 24 h of ICU admission. Propensity score matching was used to achieve a balance across baseline variables between the early intubation cohort and those patients who were intubated after the first 24 h of ICU admission. Differences in outcomes between early and delayed intubation were also assessed. We performed sensitivity analyses to consider a different time-point (48 h from ICU admission) for early and delayed intubation. RESULTS: Of the 2725 patients who received invasive mechanical ventilation, a total of 614 matched patients were included in the analysis (307 for each group). In the unmatched population, there were no differences in mortality between the early and delayed groups. After propensity score matching, patients with delayed intubation presented higher hospital mortality (27.3% versus 37.1%; p=0.01), ICU mortality (25.7% versus 36.1%; p=0.007) and 90-day mortality (30.9% versus 40.2%; p=0.02) compared with the early intubation group. Very similar findings were observed when we used a 48-h time-point for early or delayed intubation. The use of early intubation decreased after the first wave of the pandemic (72%, 49%, 46% and 45% in the first, second, third and fourth waves, respectively; first versus second, third and fourth waves p<0.001). In both the main and sensitivity analyses, hospital mortality was lower in patients receiving high-flow nasal cannula (HFNC) (n=294) who were intubated earlier. The subgroup of patients undergoing noninvasive ventilation (n=214) before intubation showed higher mortality when delayed intubation was set as that occurring after 48 h from ICU admission, but not when after 24 h. CONCLUSIONS: In patients with COVID-19 requiring invasive mechanical ventilation, delayed intubation was associated with a higher risk of hospital mortality. The use of early intubation significantly decreased throughout the course of the pandemic. Benefits of such an approach occurred more notably in patients who had received HFNC.


Subject(s)
COVID-19 , Noninvasive Ventilation , Respiratory Insufficiency , Humans , Prospective Studies , Pandemics , Intubation, Intratracheal/adverse effects , Respiration, Artificial/adverse effects , Respiratory Insufficiency/therapy , Respiratory Insufficiency/etiology , Intensive Care Units
6.
Crit Care ; 26(1): 302, 2022 10 03.
Article in English | MEDLINE | ID: mdl-36192781

ABSTRACT

BACKGROUND: The incidence of sepsis can be estimated between 250 and 500 cases/100.000 people per year and is responsible for up to 6% of total hospital admissions. Identified as one of the most relevant global health problems, sepsis is the condition that generates the highest costs in the healthcare system. Important changes in the management of septic patients have been included in recent years; however, there is no information about how changes in the management of sepsis-associated organ failure have contributed to reduce mortality. METHODS: A retrospective analysis was conducted from hospital discharge records from the Minimum Basic Data Set Acute-Care Hospitals (CMBD-HA in Catalan language) for the Catalan Health System (CatSalut). CMBD-HA is a mandatory population-based register of admissions to all public and private acute-care hospitals in Catalonia. Sepsis was defined by the presence of infection and at least one organ dysfunction. Patients hospitalized with sepsis were detected, according ICD-9-CM (since 2005 to 2017) and ICD-10-CM (2018 and 2019) codes used to identify acute organ dysfunction and infectious processes. RESULTS: Of 11.916.974 discharges from all acute-care hospitals during the study period (2005-2019), 296.554 had sepsis (2.49%). The mean annual sepsis incidence in the population was 264.1 per 100.000 inhabitants/year, and it increased every year, going from 144.5 in 2005 to 410.1 in 2019. Multiorgan failure was present in 21.9% and bacteremia in 26.3% of cases. Renal was the most frequent organ failure (56.8%), followed by cardiovascular (24.2%). Hospital mortality during the study period was 19.5%, but decreases continuously from 25.7% in 2005 to 17.9% in 2019 (p < 0.0001). The most important reduction in mortality was observed in cases with cardiovascular failure (from 47.3% in 2005 to 31.2% in 2019) (p < 0.0001). In the same way, mean mortality related to renal and respiratory failure in sepsis was decreased in last years (p < 0.0001). CONCLUSIONS: The incidence of sepsis has been increasing in recent years in our country. However, hospital mortality has been significantly reduced. In septic patients, all organ failures except liver have shown a statistically significant reduction on associated mortality, with cardiovascular failure as the most relevant.


Subject(s)
Sepsis , Shock, Septic , Hospital Mortality , Humans , Multiple Organ Failure , Retrospective Studies , Sepsis/complications
7.
Int J Qual Health Care ; 34(1)2022 Mar 28.
Article in English | MEDLINE | ID: mdl-35289365

ABSTRACT

BACKGROUND: The overburdening of the healthcare system during the coronavirus disease 19 (COVID-19) pandemic is driving the need to create new tools to improve the management of inter-hospital transport for patients with a severe COVID-19 infection. OBJECTIVE: The aim of this study was to analyse the usefulness of the application of a prioritization score (IHTCOVID-19) for inter-hospital transfer of patients with COVID-19 infection. METHODS: The study has a quasi-experimental design and was conducted on the Medical Emergency System, the pre-hospital emergency department of the public company belonging to the Autonomous Government of Catalonia that manages urgent healthcare in the region. Patients with a severe COVID-19 infection requiring inter-hospital transport were consecutively included. The pre-intervention period was from 1 to 31 March 2020, and the intervention period with the IHTCOVID-19 score was from 1 to 30 April 2020 (from 8 am to 8 pm). The prioritization score comprises four priority categories, with Priority 0 being the highest and Priority 3 being the lowest. Inter-hospital transfer (IHT) management times (alert-assignment time, resource management time and total central management time) and their variability were evaluated according to whether or not the IHTCOVID-19 score was applied. RESULTS: A total of 344 IHTs were included: 189 (54.9%) in the pre-intervention period and 155 (45.1%) in the post-intervention period. The majority of patients were male and the most frequent age range was between 50 and 70 years. According to the IHTCOVID-19 score, 12 (3.5%) transfers were classified as Priority 0, 66 (19.4%) as Priority 1, 247 (71.8%) as Priority 2 and 19 (5.6%) as Priority 3. Overall, with the application of the IHTCOVID-19 score, there was a significant reduction in total central management time [from 112.4 (inter-quartile range (IQR) 281.3) to 89.8 min (IQR 154.9); P = 0.012]. This significant reduction was observed in Priority 0 patients [286.2 (IQR 218.5) to 42.0 min (IQR 58); P = 0.018] and Priority 1 patients [130.3 (IQR 297.3) to 75.4 min (IQR 91.1); P = 0.034]. After applying the IHTCOVID-19 score, the average time of the process decreased by 22.6 min, and variability was reduced from 618.1 to 324.0 min. CONCLUSION: The application of the IHTCOVID-19 score in patients with a severe COVID-19 infection reduces IHT management times and variability.


Subject(s)
COVID-19 , Aged , COVID-19/epidemiology , Female , Hospitals , Humans , Male , Middle Aged , Time Management
8.
Crit Care ; 26(1): 37, 2022 02 08.
Article in English | MEDLINE | ID: mdl-35135588

ABSTRACT

BACKGROUND: Non-invasive oxygenation strategies have a prominent role in the treatment of acute hypoxemic respiratory failure during the coronavirus disease 2019 (COVID-19). While the efficacy of these therapies has been studied in hospitalized patients with COVID-19, the clinical outcomes associated with oxygen masks, high-flow oxygen therapy by nasal cannula and non-invasive mechanical ventilation in critically ill intensive care unit (ICU) patients remain unclear. METHODS: In this retrospective study, we used the best of nine covariate balancing algorithms on all baseline covariates in critically ill COVID-19 patients supported with > 10 L of supplemental oxygen at one of the 26 participating ICUs in Catalonia, Spain, between March 14 and April 15, 2020. RESULTS: Of the 1093 non-invasively oxygenated patients at ICU admission treated with one of the three stand-alone non-invasive oxygenation strategies, 897 (82%) required endotracheal intubation and 310 (28%) died during the ICU stay. High-flow oxygen therapy by nasal cannula (n = 439) and non-invasive mechanical ventilation (n = 101) were associated with a lower rate of endotracheal intubation (70% and 88%, respectively) than oxygen masks (n = 553 and 91% intubated), p < 0.001. Compared to oxygen masks, high-flow oxygen therapy by nasal cannula was associated with lower ICU mortality (hazard ratio 0.75 [95% CI 0.58-0.98), and the hazard ratio for ICU mortality was 1.21 [95% CI 0.80-1.83] for non-invasive mechanical ventilation. CONCLUSION: In critically ill COVID-19 ICU patients and, in the absence of conclusive data, high-flow oxygen therapy by nasal cannula may be the approach of choice as the primary non-invasive oxygenation support strategy.


Subject(s)
COVID-19 , Noninvasive Ventilation , Respiratory Insufficiency , COVID-19/therapy , Cannula , Humans , Intensive Care Units , Intubation, Intratracheal , Oxygen Inhalation Therapy , Respiratory Insufficiency/therapy , Retrospective Studies , SARS-CoV-2 , Spain
9.
Emergencias ; 34(1): 29-37, 2022 02.
Article in English, Spanish | MEDLINE | ID: mdl-35103441

ABSTRACT

OBJECTIVES: To develop and validate a triage scale (Spanish acronym, TIHCOVID) to assign priority by predicting critical events in patients with severe COVID-19 who are candidates for interhospital transfer. MATERIAL AND METHODS: Prospective cohort study in 2 periods for internal (February-April 2020) and external (October-December 2020) validation. We included consecutive patients with severe COVID-19 who were transported by the emergency medical service of Catalonia. A risk model was developed to predict mortality based on variables recorded on first contact between the regional emergency coordination center and the transferring hospital. The model's performance was evaluated by means of calibration and discrimination, and the results for the first and second periods were compared. RESULTS: Nine hundred patients were included, 450 in each period. In-hospital mortality was 33.8%. The 7 predictors included in the final model were age, comorbidity, need for prone positioning, renal insufficiency, use of high-flow nasal oxygen prior to mechanical ventilation, and a ratio of PaO2 to inspired oxygen fraction of less than 50. The performance of the model was good (Brier score, 0.172), and calibration and discrimination were consistent. We found no significant differences between the internal and external validation steps with respect to either the calibration slopes (0.92 [95% CI, 0.91-0.93] vs 1.12 [95% CI, 0.6-1.17], respectively; P = .150) or discrimination (area under the curve, 0.81 [95% CI, 0.75-0.84] vs 0.85 [95% CI, 0.81-0.89]; P = .121). CONCLUSION: The TIHCOVID tool may be useful for triage when assigning priority for patients with severe COVID-19 who require transfer between hospitals.


OBJETIVO: Desarrollar y validar una escala predictiva de eventos críticos en pacientes con infección grave por COVID-19 candidatos a traslado interhospitalario (TIH) que facilite el triaje y la priorización del transporte sanitario. METODO: Estudio de cohortes prospectivo divido en dos periodos: validación interna (febrero-abril 2020) y validación externa (octubre-diciembre 2020). Se incluyeron consecutivamente los pacientes con infección grave por COVID-19 trasladados por el Sistema de Emergencias Médicas de Cataluña. Se construyó un modelo predictivo de las variables asociadas a la mortalidad recogidas en el momento del primer contacto entre el hospital emisor y el centro de coordinación. Se calculó el rendimiento del modelo y se comparó la validación interna y externa, evaluando la calibración y la discriminación. RESULTADOS: Se incluyeron 900 pacientes, 450 pacientes en cada periodo de estudio. La mortalidad durante el ingreso fue del 33,8%. Las 7 variables predictoras incluidas en el modelo final fueron edad, comorbilidad, pronación, insuficiencia renal aguda, uso de oxigenoterapia de alto flujo previa a la ventilación mecánica invasiva, tabaquismo activo y un valor de PaO2/FiO2 50. El modelo mostró un buen rendimiento (Brier = 0,172) y consistencia en la calibración y discriminación. No se objetivaron diferencias en la pendiente de calibración [0,92 (IC 95%: 0,91-0,93) vs 1,12 (IC 95%: 0,6-1,17); p = 0,150] ni en la capacidad discriminativa [ABC 0,81 (IC 95%: 0,75-0,84) vs ABC de 0,85 (IC 95%: 0,81-0,89), p = 0,121] entre la validación interna y externa. CONCLUSIONES: La escala TIHCOVID puede ser de ayuda para el triaje de pacientes con infección COVID-19 grave que precisan traslado interhospitalario.


Subject(s)
COVID-19 , Emergency Medical Services , Humans , Prospective Studies , SARS-CoV-2 , Triage
10.
Emergencias (Sant Vicenç dels Horts) ; 34(1): 29-37, feb. 2022. ilus, tab, graf
Article in Spanish | IBECS | ID: ibc-203339

ABSTRACT

Objetivo. Desarrollar y validar una escala predictiva de eventos críticos en pacientes con infección grave por COVID-19 candidatos a traslado interhospitalario (TIH) que facilite el triaje y la priorización del transporte sanitario. Método. Estudio de cohortes prospectivo divido en dos periodos: validación interna (febrero-abril 2020) y validación externa (octubre-diciembre 2020). Se incluyeron consecutivamente los pacientes con infección grave por COVID-19 trasladados por el Sistema de Emergencias Médicas de Cataluña. Se construyó un modelo predictivo de las variables asociadas a la mortalidad recogidas en el momento del primer contacto entre el hospital emisor y el centro de coordinación. Se calculó el rendimiento del modelo y se comparó la validación interna y externa, evaluando la calibración y la discriminación. Resultados. Se incluyeron 900 pacientes, 450 pacientes en cada periodo de estudio. La mortalidad durante el ingreso fue del 33,8%. Las 7 variables predictoras incluidas en el modelo final fueron edad, comorbilidad, pronación, insuficiencia renal aguda, uso de oxigenoterapia de alto flujo previa a la ventilación mecánica invasiva, tabaquismo activo y un valor de PaO2/FiO2 < 50. El modelo mostró un buen rendimiento (Brier = 0,172) y consistencia en la calibración y discriminación. No se objetivaron diferencias en la pendiente de calibración [0,92 (IC 95%: 0,91-0,93) vs 1,12 (IC 95%: 0,6-1,17); p = 0,150] ni en la capacidad discriminativa [ABC 0,81 (IC 95%: 0,75-0,84) vs ABC de 0,85 (IC 95%: 0,81-0,89), p = 0,121] entre la validación interna y externa. Conclusiones. La escala TIHCOVID puede ser de ayuda para el triaje de pacientes con infección COVID-19 grave que precisan traslado interhospitalario.


Objectives. To develop and validate a triage scale (Spanish acronym, TIHCOVID) to assign priority by predicting critical events in patients with severe COVID-19 who are candidates for interhospital transfer. Methods. Prospective cohort study in 2 periods for internal (February–April 2020) and external (October–December 2020) validation. We included consecutive patients with severe COVID-19 who were transported by the emergency medical service of Catalonia. A risk model was developed to predict mortality based on variables recorded on first contact between the regional emergency coordination center and the transferring hospital. The model’s performance was evaluated by means of calibration and discrimination, and the results for the first and second periods were compared. Results. Nine hundred patients were included, 450 in each period. In-hospital mortality was 33.8%. The 7 predictors included in the final model were age, comorbidity, need for prone positioning, renal insufficiency, use of high-flow nasal oxygen prior to mechanical ventilation, and a ratio of PaO2 to inspired oxygen fraction of less than 50. The performance of the model was good (Brier score, 0.172), and calibration and discrimination were consistent. We found no significant differences between the internal and external validation steps with respect to either the calibration slopes (0.92 [95% CI, 0.91–0.93] vs 1.12 [95% CI, 0.6–1.17], respectively; P = .150) or discrimination (area under the curve, 0.81 [95% CI, 0.75–0.84] vs 0.85 [95% CI, 0.81–0.89]; P = .121). Conclusion. The TIHCOVID tool may be useful for triage when assigning priority for patients with severe COVID-19 who require transfer between hospitals.


Subject(s)
Humans , Health Sciences , Severe acute respiratory syndrome-related coronavirus , Emergency Medical Services , Emergencies , Prospective Studies , Triage , Critical Care , Regional Medical Programs
11.
Lancet Infect Dis ; 21(9): 1313-1323, 2021 09.
Article in English | MEDLINE | ID: mdl-33894131

ABSTRACT

BACKGROUND: Staphylococcus aureus remains a common cause of ventilator-associated pneumonia, with little change in incidence over the past 15 years. We aimed to evaluate the efficacy of suvratoxumab, a monoclonal antibody targeting the α toxin, in reducing the incidence of S aureus pneumonia in patients in the intensive care unit (ICU) who are on mechanical ventilation. METHODS: We did a multicentre, randomised, double-blind, placebo-controlled, parallel-group, phase 2 pilot trial at 31 hospitals in Belgium, the Czech Republic, France, Germany, Greece, Hungary, Portugal, Spain, and Switzerland. Eligible patients were in the ICU, aged ≥18 years, were intubated and on mechanical ventilation, were positive for S aureus colonisation of the lower respiratory tract, as assessed by quantitative PCR (qPCR) analysis of endotracheal aspirate, and had not been diagnosed with new-onset pneumonia. Patients were excluded if they had confirmed or suspected acute ongoing staphylococcal disease; had received antibiotics for S aureus infection for more than 48 h within 72 h of randomisation; had a Clinical Pulmonary Infection Score of 6 or higher; had an acute physiology and chronic health evaluation II score of 25 or higher with a Glasgow coma scale (GCS) score of more than 5, or an acute physiology and chronic health evaluation II score of at least 30 with a GCS score of 5 or less; had a Sequential Organ Failure Assessment score of 9 or higher; or had active pulmonary disease that would impair the ability to diagnose pneumonia. Colonised patients were randomly assigned (1:1:1), by use of an interactive voice or web response system, to receive either a single intravenous infusion of suvratoxumab 2000 mg, suvratoxumab 5000 mg, or placebo. Randomisation was done in blocks of size four, stratified by country and by whether patients had received systemic antibiotics for S aureus infection. Patients, investigators, and study staff involved in the treatment or clinical evaluation of patients were masked to patient assignment. The primary efficacy endpoint was the incidence of S aureus pneumonia at 30 days, as determined by a masked independent endpoint adjudication committee, in all patients who received their assigned treatment (modified intention-to-treat [ITT] population). Primary safety endpoints were the incidence of treatment-emergent adverse events at 30 days, 90 days, and 190 days after treatment, and the incidence of treatment-emergent serious adverse events, adverse events of special interest, and new-onset chronic disease at 190 days after treatment. All primary safety endpoints were assessed in the modified ITT population. This trial is registered with ClinicalTrials.gov (NCT02296320) and the EudraCT database (2014-001097-34). FINDINGS: Between Oct 10, 2014, and April 1, 2018, 767 patients were screened, of whom 213 patients with confirmed S aureus colonisation of the lower respiratory tract were randomly assigned to the suvratoxumab 2000 mg group (n=15), the suvratoxumab 5000 mg group (n=96), or the placebo group (n=102). Two patients in the placebo group did not receive treatment after randomisation because their clinical conditions changed and they no longer met the eligibility criteria for dosing. As adjudicated by the data monitoring committee at an interim analysis, the suvratoxumab 2000 mg group was discontinued on the basis of predefined pharmacokinetic criteria. At 30 days after treatment, 17 (18%) of 96 patients in the suvratoxumab 5000 mg group and 26 (26%) of 100 patients in the placebo group had developed S aureus pneumonia (relative risk reduction 31·9% [90% CI -7·5 to 56·8], p=0·17). The incidence of treatment-emergent adverse events at 30 days were similar between the suvratoxumab 5000 mg group (87 [91%]) and the placebo group (90 [90%]). The incidence of treatment-emergent serious adverse events at 30 days were also similar between the suvratoxumab 5000 mg group (36 [38%]) and the placebo group (32 [32%]). No significant difference in the incidence of treatment-emergent adverse events between the two groups at 90 days (89 [93%] in the suvratoxumab 5000 mg group vs 92 [92%] in the placebo group) and at 190 days (93 [94%] vs 93 [93%]) was observed. 40 (40%) patients in the placebo group and 50 (52%) in the suvratoxumab 5000 mg group had a serious adverse event at 190 days. In the suvratoxumab 5000 mg group, one (1%) patient reported at least one treatment-emergent serious adverse event related to treatment, two (2%) patients reported an adverse event of special interest, and two (2%) reported a new-onset chronic disease. INTERPRETATION: In patients in the ICU receiving mechanical ventilation with qPCR-confirmed S aureus colonisation of the lower respiratory tract, the incidence of S aureus pneumonia at 30 days was not significantly lower following treatment with 5000 mg suvratoxumab than with placebo. Despite these negative results, monoclonal antibodies still represent one promising therapeutic option to reduce antibiotic consumption that require further exploration and studies. FUNDING: AstraZeneca, with support from the Innovative Medicines Initiative Joint Undertaking.


Subject(s)
Antibodies, Monoclonal, Humanized/therapeutic use , Broadly Neutralizing Antibodies/therapeutic use , Pneumonia, Ventilator-Associated/prevention & control , Staphylococcal Infections/prevention & control , Staphylococcus aureus/drug effects , Adolescent , Adult , Aged , Antibodies, Monoclonal, Humanized/administration & dosage , Belgium , Broadly Neutralizing Antibodies/administration & dosage , Czech Republic , Double-Blind Method , Female , France , Germany , Greece , Humans , Hungary , Lung , Male , Middle Aged , Pilot Projects , Portugal , Respiration, Artificial , Spain , Switzerland , Treatment Outcome , Young Adult
12.
Medicine (Baltimore) ; 96(13): e6515, 2017 Mar.
Article in English | MEDLINE | ID: mdl-28353609

ABSTRACT

This paper aims to analyze agreement in the assessment of external chest compressions (ECC) by 3 human raters and dedicated feedback software.While 54 volunteer health workers (medical transport technicians), trained and experienced in cardiopulmonary resuscitation (CPR), performed a complete sequence of basic CPR maneuvers on a manikin incorporating feedback software (Laerdal PC v 4.2.1 Skill Reporting Software) (L), 3 expert CPR instructors (A, B, and C) visually assessed ECC, evaluating hand placement, compression depth, chest decompression, and rate. We analyzed the concordance among the raters (A, B, and C) and between the raters and L with Cohen's kappa coefficient (K), intraclass correlation coefficients (ICC), Bland-Altman plots, and survival-agreement plots.The agreement (expressed as Cohen's K and ICC) was ≥0.54 in only 3 instances and was ≤0.45 in more than half. Bland-Altman plots showed significant dispersion of the data. The survival-agreement plot showed a high degree of discordance between pairs of raters (A-L, B-L, and C-L) when the level of tolerance was set low.In visual assessment of ECC, there is a significant lack of agreement among accredited raters and significant dispersion and inconsistency in data, bringing into question the reliability and validity of this method of measurement.


Subject(s)
Cardiopulmonary Resuscitation/standards , Manikins , Process Assessment, Health Care/methods , Adult , Clinical Competence , Female , Humans , Male , Software
13.
J Crit Care ; 30(4): 711-4, 2015 Aug.
Article in English | MEDLINE | ID: mdl-25797396

ABSTRACT

BACKGROUND: We aimed to analyze compliance with 2010 European guidelines' quality criteria for external chest compressions (ECC) during 2 minutes of uninterrupted cardiopulmonary resuscitation. METHODS: Seventy-two healthy nurses and physicians trained in advanced cardiopulmonary resuscitation performed 2 uninterrupted minutes of ECC on a training manikin (Resusci Anne Advanced SkillTrainer; Laerdal Medical AS, Stavanger, Norway) that enabled us to measure the depth and rate of ECC. When professionals agreed to participate in the study, we recorded their age, body mass index (BMI), smoking habit, and their own subjective estimation of their physical fitness. To measure fatigue, we analyzed participants' heart rates, percentage of maximum tolerated heart rate (MHR), and subjective perception of their fatigue on a visual analog scale. RESULTS: Nearly half (48.6%) the rescuers failed to achieve a minimum average ECC depth of 50 mm. Only 48.1% of ECCs fulfilled the 2010 guidelines' quality criteria; quality deteriorated mainly after the first minute. Poor ECC quality and deteriorating quality after the first minute were associated with BMI < 23 kg/m(2). Rescuers with BMI ≥ 23 kg/m(2) fulfilled the quality criteria throughout the 2 minutes, whereas those with BMI < 23 kg/m(2) fulfilled them for 80% of ECCs during the first minute, but for only 30% at the end of the 2 minutes. CONCLUSIONS: Compliance with the 2010 guidelines' quality criteria is often poor, mainly due to lack of proper depth. The greater depth recommended in the 2010 guidelines with respect to previous guidelines requires greater force, so BMI < 23 kg/m(2) could hinder compliance. Limiting each rescuer's uninterrupted time doing ECC to 1 minute could help ensure compliance.


Subject(s)
Cardiopulmonary Resuscitation/standards , Guideline Adherence/statistics & numerical data , Heart Massage/standards , Manikins , Nurses , Physicians , Practice Guidelines as Topic , Adult , Body Mass Index , Cardiopulmonary Resuscitation/methods , Fatigue , Female , Heart Massage/methods , Heart Rate/physiology , Humans , Male , Physical Fitness , Pressure , Time Factors , Young Adult
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