IMPORTANCE Emergency medical services (EMS) commonly perform endotracheal intubation (ETI) or insertion of supraglottic airways, such as the laryngeal tube (LT), on patients with out-of-hospital cardiac arrest (OHCA). The optimal method for OHCA advanced airway management is unknown. OBJECTIVE To compare the effectiveness of a strategy of initial LT insertion vs initial ETI in adults with OHCA. DESIGN, SETTING, AND PARTICIPANTS Multicenter pragmatic cluster-crossover clinical trial involving EMS agencies from the Resuscitation Outcomes Consortium. The trial included 3004 adults with OHCA and anticipated need for advanced airway management who were enrolled from December 1, 2015, to November 4, 2017. The final date of follow-up was November 10, 2017. INTERVENTIONS Twenty-seven EMS agencies were randomized in 13 clusters to initial airway management strategy with LT (n = 1505 patients) or ETI (n = 1499 patients), with crossover to the alternate strategy at 3-to 5-month intervals. MAIN OUTCOMES AND MEASURES The primary outcome was 72-hour survival. Secondary outcomes included return of spontaneous circulation, survival to hospital discharge, favorable neurological status at hospital discharge (Modified Rankin Scale score Յ3), and key adverse events. RESULTS Among 3004 enrolled patients (median [interquartile range] age, 64 [53-76] years, 1829 [60.9%] men), 3000 were included in the primary analysis. Rates of initial airway success were 90.3% with LT and 51.6% with ETI. Seventy-two hour survival was 18.3% in the LT group vs 15.4% in the ETI group (adjusted difference, 2.9% [95% CI, 0.2%-5.6%]; P = .04). Secondary outcomes in the LT group vs ETI group were return of spontaneous circulation (27.9% vs 24.3%; adjusted difference, 3.6% [95% CI, 0.3%-6.8%]; P = .03); hospital survival (10.8% vs 8.1%; adjusted difference, 2.7% [95% CI, 0.6%-4.8%]; P = .01); and favorable neurological status at discharge (7.1% vs 5.0%; adjusted difference, 2.1% [95% CI, 0.3%-3.8%]; P = .02). There were no significant differences in oropharyngeal or hypopharyngeal injury (0.2% vs 0.3%), airway swelling (1.1% vs 1.0%), or pneumonia or pneumonitis (26.1% vs 22.3%). CONCLUSIONS AND RELEVANCE Among adults with OHCA, a strategy of initial LT insertion was associated with significantly greater 72-hour survival compared with a strategy of initial ETI. These findings suggest that LT insertion may be considered as an initial airway management strategy in patients with OHCA, but limitations of the pragmatic design, practice setting, and ETI performance characteristics suggest that further research is warranted.
Airway management is an important component of resuscitation from out-of-hospital cardiac arrest (OHCA). The optimal approach to advanced airway management is unknown. The Pragmatic Airway Resuscitation Trial (PART) will compare the effectiveness of endotracheal intubation (ETI) and Laryngeal Tube (LT) insertion upon 72-hour survival in adult OHCA. Encompassing United States Emergency Medical Services agencies affiliated with the Resuscitation Outcomes Consortium (ROC), PART will use a cluster-crossover randomized design. Participating subjects will include adult, non-traumatic OHCA requiring bag-valve-mask ventilation. Trial interventions will include 1) initial airway management with ETI and 2) initial airway management with LT. The primary and secondary trial outcomes are 72-hour survival and return of spontaneous circulation. Additional clinical outcomes will include airway management process and adverse events. The trial will enroll a total of 3,000 subjects. Results of PART may guide the selection of advanced airway management strategies in OHCA.
Objectives: Exception from informed consent (EFIC) for research in emergency settings requires investigators to notify enrolled subjects, family members, or legally authorized representatives about inclusion in the study. We examined the success rate of a notification strategy including mail services for subjects enrolled in EFIC trials. Methods:We describe notification attempts for subjects in three out-of-hospital cardiac arrest clinical trials in both urban and rural areas around Pittsburgh, Pennsylvania, between the years 2000 and 2014. We examined the time required to notify subjects and the success of contacting subjects or their representatives when notified in person (if alive), by mail (if alive and unable to reach in person), or by mail (if the subject was deceased). We characterized comments received from subjects or their representatives as positive, neutral, or negative.Results: We attempted notification on a total of 1,912 subjects, 1,762 by mail, and 163 in person. Of these, 1,767 (92%) notification forms were successfully delivered, and 431 (24%) were signed and returned. Only 16 subjects or representatives (0.91%) requested to withdraw from the study. In-person notifications were more likely to be signed than mailed notifications (69% vs. 20%; p < 0.001). A total of 3.2% of recipients contacted investigators by phone or letter in response to notifications, but only five recipients expressed negative attitudes toward the trial. Ninety percent of subjects were notified within 35 days of the incident. Time to notification was shorter for in person (median = 5 days, interquartile range [IQR] = 2 to 10 days) than for deceased and mailed (11 days, IQR = 8 to 14 days) or alive and mailed (20 days, IQR = 14 to 29 days). Conclusions:It is possible to successfully notify recipients of enrollment in a study using EFIC over 90% of the time within 35 days, although only 24% of recipients will sign and return a form. Fewer than 1% of subjects withdraw from the study, and fewer than 5% contact investigators, usually for neutral reasons. ACADEMIC EMERGENCY MEDICINE2016;23:772-775
Purpose/Objective: The role of perceived social support from specific sources (e.g., families, friends, and significant others) on the development of postinjury posttraumatic stress disorder (PTSD) and associated psychological symptoms (e.g., depression and anxiety) remains relatively unexplored. We examined the predictive role of social support from specific sources on psychological symptoms among emergency department (ED) patients following motor vehicle crash (MVC). Research Methods/Design: Sixty-three injured patients (63.5% female; 37 years old on average) with moderately painful complaints were recruited in the EDs of two Level-1 trauma centers within 24 hr post-MVC. In the ED, participants completed surveys of baseline psychological symptoms and perceived social support; follow-up surveys were completed at 90 days postinjury. Results: Most of the sample (84.1%) was discharged home from the ED with predominantly mild injuries and did not require hospitalization. After adjusting for race, sex, age, and baseline symptoms, hierarchical regression analyses demonstrated that lower perceived social support in the ED predicted higher PTSD symptoms and depressive symptoms (but not anxiety) at 90 days. This effect seemed to be specific to significant others and friends but not family. Conclusions/Implications: MVC-related injuries are robust contributors to psychological sequelae. These findings extend prior work by highlighting that perceived social support, particularly from significant others and friends, provides unique information regarding the development of psychological symptoms following predominantly mild MVC-related injuries. This data may serve to inform recovery expectations. Impact and ImplicationsMotor-vehicle-crash-related injuries are robust contributors to postinjury psychological sequelae; the identification of mitigating factors for postinjury comorbidities is critical to improve recovery and functional outcomes. Low perceived social support, as measured in the emergency department within 24 hr of the injury, generally predicts higher symptoms of posttraumatic stress disorder and depression at 90 days postinjury. Findings from this study suggest that it is important to differentiate between interpersonal domains of social support as social support from significant others and friends uniquely predicts postinjury posttraumatic stress disorder and depressive symptoms. Additional research is warranted to determine whether these findings have clinical utility and to clarify and specify the sources of support and their relation to the injured patient.
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