Comprehensive analysis of coagulation factor delivery strategies in a cohort of trauma patients.

PURPOSE: The 5th edition of The European recommendations for the management of major bleeding and coagulopathy following trauma leaves room for various coagulation factor administration strategies. The present study examines these strategies reporting prevalence and timing of administration, quantity dispensed, and transfusion ratios in French trauma centers and their compliance with recommendations alongside associated mortality data. METHODS: All adult patients, admitted directly to participating centers between 2011 and 2019, were extracted from a trauma registry. Two subpopulations were studied: severe hemorrhage (SH) and massive transfusion (MT) groups. RESULTS: A total of 19,396 patients were included, among whom 8.4% (1630) experienced SH and 3% (579) received MT. Within the first 24 hours, 10% received fresh frozen plasma (FFP), rising to 93% and 99% in the subgroups of patients experiencing SH and MT respectively. Only, 8% received fibrinogen concentrate (FC), increasing to 75% and 92% in subgroups SH and MT respectively. Co-administration of FFP and FC became the dominant strategy with 68% of patients at 6 h and 72% at 24 h in SH subgroup. In unadjusted data, mortality was systematically lower in groups that complied with recommendations, a lower mortality than expected was mostly observed in contrast to non-compliant subgroups. The per-patient compliance to studied recommendations was 21% and 22% in SH and MT subgroups. CONCLUSION: The main hemostatic strategy for major bleeding combined the administration of both FFP and FC, favoring an early additional supply of fibrinogen. Compliance with the recommendations was low in SH and MT subgroups.

In-hospital cardiac arrest rhythm analysis by anesthesiologists: a diagnostic performance study.

PURPOSE: In-hospital cardiac arrest is associated with high morbidity and mortality, with an overall survival rate at one year of approximately 13%. The first cardiac rhythm is often analyzed by anesthesiologist-intensivists. We aimed to determine the diagnostic performance of anesthesiologist-intensivists when distinguishing between shockable and nonshockable rhythms. METHODS: We conducted a simulation-based, multicentre, prospective, observational study between May 2019 and March 2020. The responses of the participants were used to calculate individual sensitivity (defined as the proportion of decisions to shock for shockable rhythms) and individual specificity (defined as the proportion of decisions not to shock for nonshockable rhythms). The main outcome measure was the overall diagnostic performance, defined as the overall sensitivity and specificity. Secondary outcome measures were the sensitivity and specificity of participants' decisions for each type of cardiac arrest rhythm and their decision-making times. RESULTS: Among the 267 physicians contacted, 179 (67%) completed the test. The median [interquartile range (IQR)] overall sensitivity was 88 [79-95]% and the median overall specificity was 86 [77-92]%. Among shockable rhythms, the median [IQR] sensitivity was 100 [100-100]% for ventricular tachycardia (VT), 100 [100-100]% for coarse ventricular fibrillation (VF), and 60 [20-100]% for fine VF. The median [IQR] specificities for nonshockable rhythms were 93 [86-100]% for asystole and 83 [72-86]% for pulseless electrical activity. The median decision times ranged from 2.0 to 3.5 sec. CONCLUSION: Anesthesiologist-intensivists were quickly and effectively able to analyze rhythms in this simulation-based study. Participants' sensitivity in deciding to deliver shocks for VT and coarse VF was excellent, while specificity of their decisions for pulseless electrical activity was insufficient.

RéSUMé: OBJECTIF: L'arrêt cardiaque intra-hospitalier est associé à une morbidité et mortalité élevées, associées à un taux de survie global à un an d'environ 13 %. Le premier rythme cardiaque est souvent analysé par des anesthésiologistes-intensivistes. Nous avons cherché à déterminer la performance diagnostique des anesthésiologistes-intensivistes à distinguer un rythme choquable d'un rythme non choquable. MéTHODE: Nous avons effectué une étude observationnelle prospective, multicentrique basée sur la simulation entre mai 2019 et mars 2020. Les réponses des participants ont été utilisées pour calculer la sensibilité individuelle (définie comme étant la proportion de décisions de choquer pour les rythmes choquables) et la spécificité individuelle (définie comme la proportion de décisions de ne pas choquer pour les rythmes non choquables). Le critère d'évaluation principal était la performance diagnostique globale, définie comme étant la sensibilité et la spécificité globales. Les critères d'évaluation secondaires étaient la sensibilité et la spécificité des décisions des participants pour chaque type de rythme d'arrêt cardiaque, ainsi que le temps de prise de décision. RéSULTATS: Parmi les 267 médecins contactés, 179 (67 %) ont complété le test. La sensibilité globale médiane [écart interquartile (ÉIQ)] était de 88 [79-95] % et la spécificité globale médiane était de 86 [77-92] %. Parmi les rythmes choquables, la sensibilité médiane [ÉIQ] était de 100 [100-100] % pour la tachycardie ventriculaire (TV), de 100 [100-100] % pour la fibrillation ventriculaire (FV) large et de 60 [20-100] % pour la FV fine. Les spécificités médianes [ÉIQ] pour les rythmes non choquables étaient de 93 [86-100] % pour l'asystolie et de 83 [72-86] % pour l'activité électrique sans pouls. Les temps de décision médians variaient de 2,0 à 3,5 secondes. CONCLUSION: Les anesthésiologistes-intensivistes ont été rapidement et efficacement en mesure d'analyser les rythmes dans cette étude basée sur la simulation. La sensibilité de prendre la décision d'administrer un choc pour une TV ou une FV était excellente pour les participants, tandis que la spécificité de cette décision pour l'activité électrique sans pouls était insuffisante.

Prehospital Lyophilized Plasma Transfusion for Trauma-Induced Coagulopathy in Patients at Risk for Hemorrhagic Shock: A Randomized Clinical Trial.

Importance: Blood transfusion is a mainstay of therapy for trauma-induced coagulopathy, but the optimal modalities for plasma transfusion in the prehospital setting remain to be defined. Objective: To determine whether lyophilized plasma transfusion can reduce the incidence of trauma-induced coagulopathy compared with standard care consisting of normal saline infusion. Design, Setting, and Participants: This randomized clinical trial was performed at multiple centers in France involving prehospital medical teams. Participants included 150 adults with trauma who were at risk for hemorrhagic shock and associated coagulopathy between April 1, 2016, and September 30, 2019, with a 28-day follow-up. Data were analyzed from November 1, 2019, to July 1, 2020. Intervention: Patients were randomized in a 1:1 ratio to receive either plasma or standard care with normal saline infusion (control). Main Outcomes and Measures: The primary outcome was the international normalized ratio (INR) on arrival at the hospital. Secondary outcomes included the need for massive transfusion and 30-day survival. As a safety outcome, prespecified adverse events included thrombosis, transfusion-related acute lung injury, and transfusion-associated circulatory overload. Results: Among 150 randomized patients, 134 were included in the analysis (median age, 34 [IQR, 26-49] years; 110 men [82.1%]), with 68 in the plasma group and 66 in the control group. Median INR values were 1.21 (IQR, 1.12-1.49) in the plasma group and 1.20 (IQR, 1.10-1.39) in the control group (median difference, -0.01 [IQR, -0.09 to 0.08]; P = .88). The groups did not differ significantly in the need for massive transfusion (7 [10.3%] vs 4 [6.1%]; relative risk, 1.78 [95% CI, 0.42-8.68]; P = .37) or 30-day survival (hazard ratio for death, 1.07 [95% CI, 0.44-2.61]; P = .89). In the full intention-to-treat population (n = 150), the groups did not differ in the rates of any of the prespecified adverse events. Conclusions and Relevance: In this randomized clinical trial including severely injured patients at risk for hemorrhagic shock and associated coagulopathy, prehospital transfusion of lyophilized plasma was not associated with significant differences in INR values vs standard care with normal saline infusion. Nevertheless, these findings show that lyophilized plasma transfusion is a feasible and safe procedure for this patient population. Trial Registration: ClinicalTrials.gov Identifier: NCT02736812.

Assessment of emergency physicians' performance in identifying shockable rhythm in out-of-hospital cardiac arrest: an observational simulation study.

BACKGROUND: Emergency physicians can use a manual or an automated defibrillator to provide defibrillation of patients who had out-of-hospital cardiac arrest (OHCA). Performance of emergency physicians in identifying shockable rhythm with a manual defibrillator has been poorly explored whereas that of automated defibrillators is well known (sensitivity 0.91-1.00, specificity 0.96-0.99). We conducted this study to estimate the sensitivity/specificity and speed of shock/no-shock decision-making by prehospital emergency physicians for shockable or non-shockable rhythm, and their preference for manual versus automated defibrillation. METHODS: We developed a web application that simulates a manual defibrillator (https://simul-shock.firebaseapp.com/). In 2019, all (262) emergency physicians of six French emergency medical services were invited to participate in a study in which 60 ECG rhythms from real OHCA recordings were successively presented to the physicians for determination of whether they would or would not administer a shock. Time to decision was recorded. Answers were compared with a gold standard (concordant answers of three experts). We report sensitivity for shockable rhythms (decision to shock) and specificity for non-shockable rhythms (decision not to shock). Physicians were also asked whether they preferred manual or automated defibrillation. RESULTS: Among 215 respondents, we were able to analyse results for 190 physicians. 57% of emergency physicians preferred manual defibrillation. Median (IQR) sensitivity for a shock delivery for shockable rhythm was 0.91 (0.81-1.00); median specificity for no-shock delivery for non-shockable rhythms was 0.91 (0.80-0.96). More precisely, sensitivities for shock delivery for ventricular tachycardia (VT) and coarse ventricular fibrillation (VF) were both 1.0 (1.0-1.0); sensitivity for fine VF was 0.6 (0.2-1). Specificity for not shocking a pulseless electrical activity (PEA) was 0.83 (0.72-0.86), and for asystole, specificity was 0.93 (0.86-1). Median speed of decision-making (in seconds) were: VT 2.0 (1.6-2.7), coarse VF 2.1 (1.7-2.9), asystole 2.4 (1.8-3.5), PEA 2.8 (2.0-4.2) and fine VF 2.8 (2.1-4.3). CONCLUSIONS: Global sensitivity and specificity were comparable with published automated external defibrillator studies. Shockable rhythms with the best clinical prognoses (VT and coarse VF) were very rapidly recognised with very good sensitivity. The decision-making for fine VF or asystole and PEA was less accurate.

Important Issues to Severe Trauma Survivors: A Qualitative Study.

OBJECTIVE: Identify issues that are important to severe trauma survivors up to 3 years after the trauma. BACKGROUND: Severe trauma is the first cause of disability-adjusted life years worldwide, yet most attention has focused on acute care and the impact on long-term health is poorly evaluated. METHOD: We conducted a large-scale qualitative study based on semi-structured phone interviews. Qualitative research methods involve the systematic collection, organization, and interpretation of conversations or textual data with patients to explore the meaning of a phenomenon experienced by individuals themselves. We randomly selected severe trauma survivors (abbreviated injury score ≥3 in at least 1 body region) who were receiving care in 6 urban academic level-I trauma centers in France between March 2015 and March 2018. We conducted double independent thematic analysis. Issues reported by patients were grouped into overarching domains by a panel of 5 experts in trauma care. Point of data saturation was estimated with a mathematical model. RESULTS: We included 340 participants from 3 months to 3 years after the trauma [median age: 41 years (Q1-Q3 24-54), median injury severity score: 17 (Q1-Q3 11-22)]. We identified 97 common issues that we grouped into 5 overarching domains: body and neurological issues (29 issues elicited by 277 participants), biographical disruption (23 issues, 210 participants), psychological and personality issues (21 issues, 147 participants), burden of treatment (14 issues, 145 participants), and altered relationships (10 issues, 87 participants). Time elapsed because the trauma, injury location, or in-hospital trauma severity did not affect the distribution of these domains across participants' answers. CONCLUSIONS: This qualitative study explored trauma survivors' experiences of the long-term effect of their injury and allowed for identifying a set of issues that they consider important, including dimensions that seem overlooked in trauma research. Our findings confirm that trauma is a chronic medical condition that demands new approaches to post-discharge and long-term care.

IMPACT OF DIFFERENT VENTILATION STRATEGIES ON GAS EXCHANGES AND CIRCULATION DURING PROLONGED MECHANICAL CARDIO-PULMONARY RESUSCITATION IN A PORCINE MODEL.

ABSTRACT: Background: Optimal ventilation during cardio-pulmonary resuscitation (CPR) is still controversial. Ventilation is expected to provide sufficient arterial oxygen content and adequate carbon dioxide removal, while minimizing the risk of circulatory impairment. The objective of the present study was to compare three ventilation strategies in a porcine model during mechanical continuous chest compressions (CCC) according to arterial oxygenation and hemodynamic impact. Method: Ventricular fibrillation was induced and followed by five no-flow minutes and thirty low-flow minutes resuscitation with mechanical-CCC without vasopressive drugs administration. Three groups of eight Landras pig were randomized according to the ventilation strategy: 1. Standard nonsynchronized volume-control mode (SD-group); 2. synchronized bilevel pressure-controlled ventilation (CPV-group); 3. continuous insufflation with Boussignac Cardiac-Arrest Device (BC-group). We assessed 1. arterial blood gases, 2. macro hemodynamics, 3. tissular cerebral macro and micro-circulation and 4. airway pressure, minute ventilation at baseline and every 5 minutes during the protocol. Results: Arterial PaO2 level was higher at each measurement time in SD-group (>200 mm Hg) compare to CPV-group and BC-group ( P < 0.01). In BC-group, arterial PaCO2 level was significantly higher (>90mm Hg) than in SD and CPV groups ( P < 0.01). There was no difference between groups concerning hemodynamic parameters, cerebral perfusion and microcirculation. Conclusion: Ventilation modalities in this porcine model of prolonged CPR influence oxygenation and decarboxylation without impairing circulation and cerebral perfusion. Synchronized bi-level pressure-controlled ventilation' use avoid hyperoxia and was as efficient as asynchronized volume ventilation to maintain alveolar ventilation and systemic perfusion during prolonged CPR.

Automatic external defibrillator provided by unmanned aerial vehicle (drone) in Greater Paris: A real world-based simulation.

AIM: To reduce the delay in defibrillation of out-of-hospital cardiac arrest (OHCA) patients, recent publications have shown that drones equipped with an automatic external defibrillator (AED) appear to be effective in sparsely populated areas. To study the effectiveness of AED-drones in high-density urban areas, we developed an algorithm based on emergency dispatch parameters for the rate and detection speed of cardiac arrests and technical and meteorological parameters. METHODS: We ran a numerical simulation to compare the actual time required by the Basic Life Support team (BLSt) for OHCA patients in Greater Paris in 2017 to the time required by an AED-drone. Endpoints were the proportion of patients with "AED-drone first" and the defibrillation time gained. We built an open-source website (https://airborne-aed.org/) to allow modelling by modifying one or more parameters and to help other teams model their own OHCA data. RESULTS: Of 3014 OHCA patients, 72.2 ±â€¯0.7% were in the "no drone flight" group, 25.8 ±â€¯0.2% in the "AED-drone first" group, and 2.1 ±â€¯0.2% in the "BLSt-drone first" group. When a drone flight was authorized, it arrived an average 190 s before BLSt in 93% of cases. The possibility of flying the drone during the aeronautical night improved the results of the "AED-drone first" group the most (+60%). CONCLUSIONS: In our very high-density urban model, at most 26% of OHCA patients received an AED from an AED-drone before BLSt. The flexible parameters of our website model allows evaluation of the impact of each choice and concrete implementation of the AED-drone.

Insufficient quality of public automated external defibrillator recordings in the greater Paris area, a descriptive study.

BACKGROUND: Western countries report a significant increase in the proportion of patients who experience out-of-hospital cardiac arrests (OHCAs) and benefit from a public automated external defibrillator (pAED) before the arrival of rescue teams. However, recordings of devices recovered after resuscitation are of variable quality. Analysis of these data may inform decisions of whether to implement an internal defibrillator for survivors, and provide useful information about the performance of pAED algorithms and the actions of bystanders. OBJECTIVE: To investigate the quality of the information recorded by pAEDs during OHCAs in the Paris area. METHODS: pAED files used for some of the 8629 OHCAs that occurred in the greater Paris area between 1 January 2017 and 31 April 2019 on the day of the arrest were collected. The presence and accuracy of 23 factors required to interpret the recording was noted, including readability of the ECG, the presence of an impedance curve and the accuracy of the date and time. The recordings were analysed to assess the diagnostic and therapeutic performance of the pAEDs used. RESULTS: A total of 258 patients with an OHCA received assistance from a pAED, and 182 recordings were recovered. The pAEDs were made by 12 different manufacturers. Data extraction required eight different transmission modes and 16 software programmes; recordings were of highly heterogeneous quality. Two per cent of the recordings were of such poor quality that they were not interpretable. Among the 98% remaining, only 43% included a thoracic impedance curve, 34% the intensity of the shocks delivered and 8% the patient name. The date and time were accurate in 68% and 48% of recordings, respectively. The pAEDs had 87.6% (95% CI 83.7% to 91.0%) sensitivity and 99.5% (99.5% to 99.5%) specificity for defibrillating shockable rhythms (positive predictive value 98.2% (96.4% to 99.0%), negative predictive value 96.4% (95.3% to 96.8%)). The absence of important variables prevented the analysis of approximately half of the inappropriate decisions made by pAEDs. CONCLUSION: Collection of pAED recordings is a major challenge. Their analysis is compromised by heterogeneity and poor quality (incomplete maintenance records, patient details and logs). AED recordings are currently the most relevant resource to track pAED performance and bystander practices. The quality of these recordings needs to improve.

Mobile Smartphone Technology Is Associated With Out-of-hospital Cardiac Arrest Survival Improvement: The First Year "Greater Paris Fire Brigade" Experience.

BACKGROUND: Out-of-hospital cardiac arrest (OHCA) remains associated with very high mortality. Accelerating the initiation of efficient cardiopulmonary resuscitation (CPR) is widely perceived as key to improving outcomes. The main goal was to determine whether identification and activation of nearby first responders through a smartphone application named Staying Alive (SA) can improve survival following OHCA in a large urban area (Paris). METHODS: We conducted a nonrandomized cohort study of all adults with OHCA managed by the Greater Paris Fire Brigade during 2018, irrespective of mobile application usage. We compared survival data in cases where SA did or did not lead to the activation of nearby first responders. During dispatch, calls for OHCA were managed with or without SA. The intervention group included all cases where nearby first responders were successfully identified by SA and actively contributed to CPR. The control group included all other cases. We compared survival at hospital discharge between the intervention and control groups. We analyzed patient data, CPR metrics, and first responders' characteristics. RESULTS: Approximately 4,107 OHCA cases were recorded in 2018. Among those, 320 patients were in the control group, whereas 46 patients, in the intervention group, received first responder-initiated CPR. After adjustment for confounders, survival at hospital discharge was significantly improved for patients in the intervention group (35% vs. 16%, adjusted odds ratio = 5.9, 95% confidence interval = 2.1 to 16.5, p < 0.001). All CPR metrics were improved in the intervention group. CONCLUSIONS: We report that mobile smartphone technology was associated with OHCA survival through accelerated initiation of efficient CPR by first responders in a large urban area.

French lyophilized plasma versus normal saline for post-traumatic coagulopathy prevention and correction: PREHO-PLYO protocol for a multicenter randomized controlled clinical trial.

BACKGROUND: Post-trauma bleeding induces an acute deficiency in clotting factors, which promotes bleeding and hemorrhagic shock. However, early plasma administration may reduce the severity of trauma-induced coagulopathy (TIC). Unlike fresh frozen plasma, which requires specific hospital logistics, French lyophilized plasma (FLYP) is storable at room temperature and compatible with all blood types, supporting its use in prehospital emergency care. We aim to test the hypothesis that by attenuating TIC, FLYP administered by prehospital emergency physicians would benefit the severely injured civilian patient at risk for hemorrhagic shock. METHODS/DESIGN: This multicenter randomized clinical trial will include adults severely injured and at risk for hemorrhagic shock, with a systolic blood pressure < 70 mmHg or a Shock Index > 1.1. Two parallel groups of 70 patients will receive either FLYP or normal saline in addition to usual treatment. The primary endpoint is the International Normalized Ratio (INR) at hospital admission. Secondary endpoints are transfusion requirement, length of stay in the intensive care unit, survival rate at day 30, usability and safety related to FLYP use, and other biological coagulation parameters. CONCLUSION: With this trial, we aim to confirm the efficacy of FLYP in TIC and its safety in civilian prehospital care. The study results will contribute to optimizing guidelines for treating hemorrhagic shock in civilian settings. TRIAL REGISTRATION: ClinicalTrials.gov, NCT02736812. Registered on 13 April 2016. The trial protocol has been approved by the French ethics committee (CPP 3342) and the French Agency for the Safety of Medicines and Health Products (IDRCB 2015-A00866-43).

Improving emergency call detection of Out-of-Hospital Cardiac Arrests in the Greater Paris area: Efficiency of a global system with a new method of detection.

AIM: The detection of cardiac arrests by dispatchers allows telephone-assisted cardiopulmonary resuscitation (t-CPR) and improves Out-of-Hospital Cardiac Arrest (OHCA) survival. To enhance the OHCA detection rate, in 2012, the Paris Fire Brigade dispatch center created an original technique called "Hand On Belly" (HoB). The new algorithm that resulted has become a central point in a broader program for dispatch-assisted cardiac arrests. METHODS: This is a repeated cross-sectional study with retrospective data of four 15-day call samples recorded from 2012 to 2018. We included all calls from OHCAs cared for by Basic Life Support (BLS) teams and excluded calls where the dispatcher was not in contact directly with a witness. The primary endpoint was the successful detection of an OHCA by the dispatcher; the secondary endpoints were successful t-CPR and measurements of the different time intervals related to the call. Logistic regressions were performed to assess parameters associated with detecting OHCAs and initiating t-CPR. RESULTS: From 2012 to 2018, among the detectable OCHAs, the proportion correctly identified increased from 54% to 93%; the rate of t-CPRs from 51% to 84%. OHCA detection and t-CPR initiation were both associated with HoB breathing assessments (adjustedOR: 89, 95%CI: 31-299, and adjustedOR: 11.2, 95%CI: 1.4-149, respectively). Over the study period, the times to answering calls and the time to sending BLS teams were shorter than those recommended by international guidelines; however, the times to OHCA recognition and starting t-CPR delivery were longer. CONCLUSIONS: The HoB effectively facilitated OHCA detection in our system, which has achieved very high performance levels.

Association of Early, High Plasma-to-Red Blood Cell Transfusion Ratio With Mortality in Adults With Severe Bleeding After Trauma.

Importance: Optimal transfusion management is crucial when treating patients with trauma. However, the association of an early, high transfusion ratio of fresh frozen plasma (FFP) to packed red blood cells (PRBC) with survival remains uncertain. Objective: To study the association of an early, high FFP-to-PRBC ratio with all-cause 30-day mortality in patients with severe bleeding after trauma. Design, Setting, and Participants: This cohort study analyzes the data included in a multicenter national French trauma registry, Traumabase, from January 2012 to July 2017. Traumabase is a prospective, active, multicenter adult trauma registry that includes all consecutive patients with trauma treated at 15 trauma centers in France. Overall, 897 patients with severe bleeding after trauma were identified using the following criteria: (1) received 4 or more units of PRBC during the first 6 hours or (2) died from hemorrhagic shock before receiving 4 units of PRBC. Exposures: Eligible patients were divided into a high-ratio group, defined as an FFP-to-PRBC ratio more than 1:1.5, and a low-ratio group, defined as an FFP-to-PRBC ratio of 1:1.5 or less. The ratio was calculated using the cumulative units of FFP and PRBC received during the first 6 hours of management. Main Outcomes and Measures: A Cox regression model was used to analyze 30-day survival with the transfusion ratio as a time-dependent variable to account for survivorship bias. Results: Of the 12 217 patients included in the registry, 897 (7.3%) were analyzed (median [interquartile range] age, 38 (29-54) years; 639 [71.2%] men). The median (interquartile range) injury severity score was 34 (22-48), and the overall 30-day mortality rate was 33.6% (301 patients). A total of 506 patients (56.4%) underwent transfusion with a high ratio and 391 (43.6%) with a low ratio. A high transfusion ratio was associated with a significant reduction in 30-day mortality (hazard ratio, 0.74; 95% CI, 0.58-0.94; P = .01). When only analyzing patients who had complete data, a high transfusion ratio continued to be associated with a reduction in 30-day mortality (hazard ratio, 0.57; 95% CI, 0.33-0.97; P = .04). Conclusions and Relevance: In this analysis of the Traumabase registry, an early FFP-to-PRBC ratio of more than 1:1.5 was associated with increased 30-day survival among patients with severe bleeding after trauma. This result supports the use of early, high FFP-to-PRBC transfusion ratios in patients with severe trauma.

Measurement of Oxygen Consumption Variations in Critically Ill Burns Patients: Are the Fick Method and Indirect Calorimetry Interchangeable?

OBJECTIVES: To evaluate the interchangeability of oxygen consumption variations measured with the Fick equation (ΔVO2Fick) and indirect calorimetry (ΔVO2Haldane) in critically ill burns patients. METHODS: Prospective observational single-center study conducted in a university hospital. Twenty-two consecutive burns patients with circulatory insufficiency and hyperlactatemia (>2 mmol/L) who required a fluid challenge (FC) were included. All patients had cardiac output monitoring (transpulmonary thermodilution technique) and were ventilated and sedated. Simultaneous measurements of VO2Fick and VO2Haldane were performed before and immediately after the FC, at rest, and in hemodynamic conditions stabilized for at least 1 h. VO2Fick and VO2Haldane were measured, respectively, with the standard formulae (using arterial and central venous saturation measured with a blood gas analyzer) and with a metabolic monitor. RESULTS: Forty-four paired measurements of VO2 were obtained. At each timepoint, the median (interquartile range, 25-75) VO2Haldane values were significantly higher than the median VO2Fick values (126 (103-192) vs. 90 (66-149) mL O2/min/m (P = 0.004) before FC and 129 (105-189) vs. 80 (54-119) mL O2/min/m (P = 0.001) after FC). Correlation between the ΔVO2Fick and the ΔVO2Haldane (%) measurements was poor, with an r = 0.06, (P = 0.77). The mean bias was 8.6% [limits of agreement (LOA): -75.7%, 92.9%]. CONCLUSIONS: Analysis of agreement showed poor concordance for the ΔVO2Haldane and the ΔVO2Fick (%) with a low mean bias but large and clinically unacceptable LOA. ΔVO2Haldane and ΔVO2Fick (%) are not interchangeable in these conditions.

Patients aged over 75 years enrolled in Phase I clinical trials: the Gustave Roussy experience.

Although a third of all cancers are diagnosed after the age of 75, only 9% of elderly people are recruited in clinical trials, because of fear of the risk of toxicity. The aim of this study was to compare the tolerance and efficacy observed in Phase I trials among patients aged over 75 years with that observed in younger patients. Patients treated from 2007 to 2012 at Institut Gustave Roussy in Phase I trials were included. The conditional Cox proportional hazards model was used to compare the occurrence of AE and overall survival in a subpopulation of elderly people (EP, aged >75 years) matched with patients aged <75 years (YP) according to the same Phase I protocol and the same Royal Marsden Hospital (RMH) prognostic score. Among the 32 EP and the 158 YP, 63% and 61% experienced Grade 3-4 AEs and dose-limiting toxicities occurred in 6% and 11% in each group respectively. Age over 75 years was neither associated with a greater risk of high toxicity (HR=0.90 [CI95%, 0.47-1.70], p = 0.74) nor of death (HR=0.86; CI95%: 0.38-1.93; p = 0.71). Age over 75 years had no impact on the occurrence of either high toxicity or of death.

Percutaneous bone biopsies: comparison between flat-panel cone-beam CT and CT-scan guidance.

PURPOSE: This study was designed to compare the accuracy of targeting and the radiation dose of bone biopsies performed either under fluoroscopic guidance using a cone-beam CT with real-time 3D image fusion software (FP-CBCT-guidance) or under conventional computed tomography guidance (CT-guidance). METHODS: Sixty-eight consecutive patients with a bone lesion were prospectively included. The bone biopsies were scheduled under FP-CBCT-guidance or under CT-guidance according to operating room availability. Thirty-four patients underwent a bone biopsy under FP-CBCT and 34 under CT-guidance. We prospectively compared the two guidance modalities for their technical success, accuracy, puncture time, and pathological success rate. Patient and physician radiation doses also were compared. RESULTS: All biopsies were technically successful, with both guidance modalities. Accuracy was significantly better using FP-CBCT-guidance (3 and 5 mm respectively: p = 0.003). There was no significant difference in puncture time (32 and 31 min respectively, p = 0.51) nor in pathological results (88 and 88 % of pathological success respectively, p = 1). Patient radiation doses were significantly lower with FP-CBCT (45 vs. 136 mSv, p < 0.0001). The percentage of operators who received a dose higher than 0.001 mSv (dosimeter detection dose threshold) was lower with FP-CBCT than CT-guidance (27 vs. 59 %, p = 0.01). CONCLUSIONS: FP-CBCT-guidance for bone biopsy is accurate and reduces patient and operator radiation doses compared with CT-guidance.