ABSTRACT
Objective: This study involving automated external defibrillators (AEDs) in early treatment of refibrillation aims to evaluate the performance of a new shock advisory system (SAS) during chest compressions (CC) in out-of-hospital cardiac arrest (OHCA) patients. Methods: This work focuses on AED SAS performance as a secondary outcome of DEFI 2022 clinical prospective study, which included first-analysis shockable OHCA patients. SAS employs the Analyze Whilst Compressing (AWC) algorithm to interact with both cardiopulmonary resuscitation (CPR) and shock advice by conditional operation of two-stage ECG analysis in presence or absence of chest compressions. AWC is triggered by the first-shock recommendation. Then, after 1 min of CPR, ECG analysis during CC decides between two treatment scenarios. For patients with refibrillation, CPR is paused for immediate confirmation analysis and shock advice. For patients with non-shockable rhythms, CPR is continued for 2 min until standard analysis. Results: Clinical data from 285 OHCA patients with shock recommendation at the first-analysis by AEDs (DEFIGARD TOUCH7, Schiller Médical) consisted of 576 standard analyses, 2011 analyses during CC, 577 confirmation analyses in absence of CC. Global AED SAS performance meets the standard recommendations for arrhythmia analysis sensitivity (94.9%) and specificity (>99.3%). AWC provided innovative treatment of shockable rhythms by stopping CPR earlier than 2 min in most ventricular fibrillations (92.9%), while most non-shockable patients (86.5-95.2%) benefitted from continuous CPR for at least 2 min. Conclusion: This study provides positive evidence for routine use of AEDs with AWC-integrated algorithm for ECG analysis during CPR by first-responders in early OHCA treatment.Clinical Trial Registration: Registration number: NCT04691089, trial register: ClinicalTrials.gov.
ABSTRACT
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.