Study Results
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View full resultsBasic Information
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COMPLETED
NA
3004 participants
INTERVENTIONAL
2015-12-01
2017-12-01
Brief Summary
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Detailed Description
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The null hypothesis is that 72-hour survival is similar between primary Laryngeal Tube (LT) SGA and primary ETI airway management strategies.
Evaluated secondary outcomes will include return of spontaneous circulation, survival to hospital discharge, neurologically intact survival at hospital discharge, airway management performance, and clinical adverse events.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Endotracheal Intubation
The insertion of a plastic breathing tube through the mouth and into the trachea.
Endotracheal Intubation
In this traditional model of OHCA airway management, advanced-level Emergency Medical Services (EMS) personnel will use ETI as the primary (initial) airway management intervention. If the EMS agency is assigned to this arm, basic-level EMS personnel will use bag-valve-mask ventilation only even if they would normally use an LT.
Laryngeal Tube (King)
Insertion of a supraglottic airway (SGA)
Laryngeal Tube (King)
In this test model of OHCA airway management, advanced-level Emergency Medical Services (EMS) personnel will use LT as the primary (initial) airway management intervention. Basic-level EMS personnel will use bag-valve-mask ventilation. If trained to use LT, basic-level EMS personnel may perform LT insertion.
Interventions
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Endotracheal Intubation
In this traditional model of OHCA airway management, advanced-level Emergency Medical Services (EMS) personnel will use ETI as the primary (initial) airway management intervention. If the EMS agency is assigned to this arm, basic-level EMS personnel will use bag-valve-mask ventilation only even if they would normally use an LT.
Laryngeal Tube (King)
In this test model of OHCA airway management, advanced-level Emergency Medical Services (EMS) personnel will use LT as the primary (initial) airway management intervention. Basic-level EMS personnel will use bag-valve-mask ventilation. If trained to use LT, basic-level EMS personnel may perform LT insertion.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Adult (age ≥18 years or per local interpretation)
* Non-traumatic etiology
* Initiation of ventilatory support (e.g., bag-valve-mask device, non-rebreather mas, etc.)
Exclusion Criteria
* Known prisoners
* Major facial trauma (visible major deformity, copious oral bleeding, etc)
* Major bleeding or exsanguination (e.g., major upper or lower GI bleed, visceral perforation, major uncontrolled bleeding from laceration or injury)
* Patient receiving initial care by a non-PART participating EMS agency capable of performing ETI, LT, or other advanced airway management
* Patients with ET tube, LT or other advanced airway device inserted prior to participating EMS agency arrival (e.g., inserted by healthcare facility personnel)
* Patients with a pre-existing tracheostomy
* Obvious asphyxial cardiac arrest (e.g., choking, foreign body aspiration, angioedema, epiglottitis, trauma to mouth and face, etc.)
* Patients with a left ventricular assist device (LVAD) or total artificial heart (TAH)
* Patients with pre-existing written "do-not-attempt-resuscitation" (DNAR) orders
* Inter-facility transports
* Patients with a "do not enroll" bracelet
18 Years
ALL
No
Sponsors
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National Heart, Lung, and Blood Institute (NHLBI)
NIH
American Heart Association
OTHER
The University of Texas Health Science Center, Houston
OTHER
University of Alabama at Birmingham
OTHER
Responsible Party
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Henry E. Wang, MD, MS
Principal Investigator
Principal Investigators
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Henry E Wang, MD
Role: PRINCIPAL_INVESTIGATOR
University of Alabama, University of Texas Health Science Center at Houston
Locations
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Alabama Resuscitation Center
Birmingham, Alabama, United States
Portland Resuscitation Outcomes Consortium, Oregon Health & Sciences University
Portland, Oregon, United States
The Pittsburgh Resuscitation Network, University of Pittsburgh
Pittsburgh, Pennsylvania, United States
Dallas Center for Resuscitation Research, University of Texas Southwestern Medical Cente
Dallas, Texas, United States
University of Washington (Data Coordinating Center)
Seattle, Washington, United States
Milwaukee Resuscitation Network, Medical College of Wisconsin
Milwaukee, Wisconsin, United States
Countries
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References
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Nassal MMJ, Elola A, Aramendi E, Jaureguibeitia X, Powell JR, Idris A, Raya Krishnamoorthy BP, Daya MR, Aufderheide TP, Carlson JN, Stephens SW, Panchal AR, Wang HE. Temporal Trends in End-Tidal Capnography and Outcomes in Out-of-Hospital Cardiac Arrest: A Secondary Analysis of a Randomized Clinical Trial. JAMA Netw Open. 2024 Jul 1;7(7):e2419274. doi: 10.1001/jamanetworkopen.2024.19274.
Wang HE, Humbert A, Nichol G, Carlson JN, Daya MR, Radecki RP, Hansen M, Callaway CW, Pedroza C. Bayesian Analysis of the Pragmatic Airway Resuscitation Trial. Ann Emerg Med. 2019 Dec;74(6):809-817. doi: 10.1016/j.annemergmed.2019.05.009. Epub 2019 Jul 2.
Wang HE, Schmicker RH, Daya MR, Stephens SW, Idris AH, Carlson JN, Colella MR, Herren H, Hansen M, Richmond NJ, Puyana JCJ, Aufderheide TP, Gray RE, Gray PC, Verkest M, Owens PC, Brienza AM, Sternig KJ, May SJ, Sopko GR, Weisfeldt ML, Nichol G. 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. JAMA. 2018 Aug 28;320(8):769-778. doi: 10.1001/jama.2018.7044.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Related Links
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Resuscitation Outcomes Consortium (ROC) Public Homepage
Other Identifiers
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