TY - JOUR
T1 - Effect of a strategy of initial laryngeal tube insertion vs endotracheal intubation on 72-hour survival in adults with out-of-hospital cardiac arrest a randomized clinical trial
AU - Wang, Henry E.
AU - Schmicker, Robert H.
AU - Daya, Mohamud R.
AU - Stephens, Shannon W.
AU - Idris, Ahamed H.
AU - Carlson, Jestin N.
AU - Riccardo Colella, M.
AU - Herren, Heather
AU - Hansen, Matthew
AU - Richmond, Neal J.
AU - Puyana, Juan Carlos J.
AU - Aufderheide, Tom P.
AU - Gray, Randal E.
AU - Gray, Pamela C.
AU - Verkest, Mike
AU - Owens, Pamela C.
AU - Brienza, Ashley M.
AU - Sternig, Kenneth J.
AU - May, Susanne J.
AU - Sopko, George R.
AU - Weisfeldt, Myron L.
AU - Nichol, Graham
N1 - Funding Information:
completed and submitted the ICMJE Form for Disclosure of Potential Conflicts of Interest. Dr Wang reported receiving grants from the National Institutes of Health (NIH)/National Heart, Lung, and Blood Institute (NHLBI) and providing research consultation for Shire Inc. Mr Schmicker; Drs Daya, Aufderheide, and May; and Mrs Herren reported receiving grants from the NHLBI. Dr Idris reported receiving grants from the NIH, University of Alabama, and HeartSine Inc and being an uncompensated member of HeartSine Inc’s scientific advisory board. Dr Carlson reported receiving grants from the NHLBI and American Heart Association for intubation research. Dr Sopko reported being an employee of the NIH. Dr Nichol reported receiving salary support from Medic One Foundation; grants from NIH, Agency for Healthcare Research and Quality, and US Food and Drug Administration; and contracts from Abiomed, GE Healthcare, and ZOLL Medical Corp, and providing consultancy to ZOLL Circulation. No other disclosures were reported.
Funding Information:
Funding/Support: This study was supported by award UH2/UH3-HL125163 from the NHLBI. The Resuscitation Outcomes Consortium institutions participating in the trial were supported by a series of cooperative agreements from the NHLBI, including 5U01 HL077863 (University of Washington Data Coordinating Center), HL077866 (Medical College of Wisconsin), HL077871 (University of Pittsburgh), HL077873 (Oregon Health and Science University), HL077881 (University of Alabama at Birmingham), and HL077887 (University of Texas Southwestern Medical Center/Dallas). Ambu Inc provided laryngeal tube airways to replace equipment used by emergency medical services (EMS) agencies during the trial.
Funding Information:
This study was supported by award UH2/UH3-HL125163 from the NHLBI. The Resuscitation Outcomes Consortium institutions participating in the trial were supported by a series of cooperative agreements from the NHLBI, including 5U01 HL077863 (University of Washington Data Coordinating Center), HL077866 (Medical College of Wisconsin), HL077871 (University of Pittsburgh), HL077873 (Oregon Health and Science University), HL077881 (University of Alabama at Birmingham), and HL077887 (University of Texas Southwestern Medical Center/Dallas). Ambu Inc provided laryngeal tube airways to replace equipment used by emergency medical services (EMS) agencies during the trial.
Publisher Copyright:
© 2018 American Medical Association. All rights reserved.
PY - 2018/8/28
Y1 - 2018/8/28
N2 - 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 3), 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.
AB - 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 3), 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.
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U2 - 10.1001/jama.2018.7044
DO - 10.1001/jama.2018.7044
M3 - Article
C2 - 30167699
AN - SCOPUS:85052581464
SN - 0098-7484
VL - 320
SP - 769
EP - 778
JO - JAMA - Journal of the American Medical Association
JF - JAMA - Journal of the American Medical Association
IS - 8
ER -