Pragmatic Airway Resuscitation Trial

NCT02419573 | Completed Results DMC

• 3 other identifiers: HL077863-PART5U01HL077863UH2HL125163
• Study Type: interventional
• Target: 3,004
• Locations: 1 country
• Sites: 6

Brief Summary

The primary objective of the trial is to determine if 72-hour survival after out-of-hospital cardiac arrest (OHCA) is improved with initial endotracheal intubation (ETI) over initial laryngeal tube (LT) airway management strategies.

Conditions

Cardiac Arrest

Keywords

cardiac arrest; cardiopulmonary resuscitation; laryngeal tube; endotracheal intubation; non-traumatic Out of Hospital Cardiac Arrest (OOHCA)

Outcome Measures

Primary Outcomes (1)

• Number of Patients Alive at 72 Hours After Episode.

  Number of patient alive at 72 hours after episode.

  72 hours

Secondary Outcomes (3)

• Return of Spontaneous Circulation (ROSC)

  Patients will be followed from the time of the CA until death or ROSC whichever occurs first. The time frame for this secondary outcome may vary from minutes to hours, but is not expected to last longer than 12 hours.

• Number of Patients Alive at Hospital Discharge

  From enrollment through end of hospital course. Maximum time interval not specified. Maximum time interval observed in study was 138 days.

• Number of Patients With Favorable Neurologic Status on Hospital Discharge

  From enrollment through end of hospital course.

Study Arms (2)

Endotracheal Intubation

ACTIVE COMPARATOR

The insertion of a plastic breathing tube through the mouth and into the trachea.

Device: Endotracheal Intubation

Laryngeal Tube (King)

ACTIVE COMPARATOR

Insertion of a supraglottic airway (SGA)

Device: Laryngeal Tube (King)

Interventions

Endotracheal Intubation DEVICE

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.

Endotracheal Intubation

Laryngeal Tube (King) DEVICE

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.

Also known as: King (LT-D), King (LTS-D), King (LT)

Laryngeal Tube (King)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Out-of-hospital cardiac arrest (OHCA)
• 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.)

You may not qualify if:

• Known pregnant women
• 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

Sponsors & Collaborators

• University of Alabama at Birmingham: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator
• American Heart Association: collaborator
• The University of Texas Health Science Center, Houston: collaborator

Study Sites (6)

Alabama Resuscitation Center

Birmingham, Alabama, 35294, United States

Location

Portland Resuscitation Outcomes Consortium, Oregon Health & Sciences University

Portland, Oregon, 92739, United States

Location

The Pittsburgh Resuscitation Network, University of Pittsburgh

Pittsburgh, Pennsylvania, 15261, United States

Location

Dallas Center for Resuscitation Research, University of Texas Southwestern Medical Cente

Dallas, Texas, 75390, United States

Location

University of Washington (Data Coordinating Center)

Seattle, Washington, 98115, United States

Location

Milwaukee Resuscitation Network, Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States

Location

Related Publications (3)

• 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.

  PMID: 38967927 DERIVED

• 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.

  PMID: 31272823 DERIVED

• 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.

  PMID: 30167699 DERIVED

Related Links

• Resuscitation Outcomes Consortium (ROC) Public Homepage

MeSH Terms

Conditions

Heart Arrest

Interventions

Intubation, Intratracheal

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Airway Management; Therapeutics; Intubation; Investigative Techniques

Results Point of Contact

• Title: Henry E. Wang, MD, MS
• Organization: Unviersity of Texas Health Science Center at Houston

henry.e.wang@uth.tmc.edu

713-500-7878

Study Officials

• Henry E Wang, MD

  University of Alabama, University of Texas Health Science Center at Houston

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 25, 2015
• First Posted: April 17, 2015
• Study Start: December 1, 2015
• Primary Completion: December 1, 2017
• Study Completion: December 1, 2017
• Last Updated: January 14, 2019
• Results First Posted: December 12, 2018

Record last verified: 2018-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (6)