Pragmatic Airway Resuscitation Trial (PART)

Study Description

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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.

Condition or disease	Intervention/treatment	Phase
Cardiac Arrest	Device: Endotracheal Intubation; Device: Laryngeal Tube (King)	Not Applicable

Detailed Description:

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.

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.

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	3005 participants
Allocation:	Randomized
Intervention Model:	Crossover Assignment
Masking:	None (Open Label)
Primary Purpose:	Treatment
Official Title:	Pragmatic Trial of Airway Management in Out-of-Hospital Cardiac Arrest
Actual Study Start Date :	December 1, 2015
Actual Primary Completion Date :	December 1, 2017
Actual Study Completion Date :	December 1, 2017

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm	Intervention/treatment
Active Comparator: Endotracheal Intubation; The insertion of a plastic breathing tube through the mouth and into the trachea.	Device: 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.
Active Comparator: Laryngeal Tube (King); Insertion of a supraglottic airway (SGA)	Device: 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 Names: King (LT-D); King (LTS-D); King (LT)

Outcome Measures

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Primary Outcome Measures :

1. 72-hour survival [ Time Frame: 72 hours ]
   Patients will be followed from the time of the CA until death in the field or 72 hours after episode.

Secondary Outcome Measures :

1. Return of Spontaneous Circulation (ROSC) [ Time Frame: 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. ]
   ROSC is defined as the presence of palpable pulses
2. Airway Management Clinical Course [ Time Frame: Patients will be followed from the time of the CA until death in the field, ED (Emergency Dept) or hospital, or hospital discharge, whichever occurs first.The longest estimated period for this assessment is 6 months from the date of the CA. ]
   Airway management clinical course includes sequence of airway insertion types, airway insertion success and time, number of airway insertion attempts, and change of airway devices
3. Adverse Events [ Time Frame: Patients will be followed from the time of the CA until death in the field, ED or hospital, or hospital discharge, whichever occurs first. The longest estimated period for the outcome measure assessment is 6 months from the date of the event CA ]

Eligibility Criteria

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Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

• 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.)

Exclusion Criteria:

• 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

Contacts and Locations

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Locations

United States, Alabama
Alabama Resuscitation Center
Birmingham, Alabama, United States, 35294
United States, Oregon
Portland Resuscitation Outcomes Consortium, Oregon Health & Sciences University
Portland, Oregon, United States, 92739
United States, Pennsylvania
The Pittsburgh Resuscitation Network, University of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15261
United States, Texas
Dallas Center for Resuscitation Research, University of Texas Southwestern Medical Cente
Dallas, Texas, United States, 75390
United States, Washington
University of Washington (Data Coordinating Center)
Seattle, Washington, United States, 98115
United States, Wisconsin
Milwaukee Resuscitation Network, Medical College of Wisconsin
Milwaukee, Wisconsin, United States, 53226

Sponsors and Collaborators

University of Alabama at Birmingham

National Heart, Lung, and Blood Institute (NHLBI)

American Heart Association

The University of Texas Health Science Center, Houston

Investigators

Principal Investigator:	Henry E Wang, MD	University of Alabama, University of Texas Health Science Center at Houston

  Study Documents (Full-Text)

Documents provided by Henry E. Wang, MD, MS, University of Alabama at Birmingham:

Study Protocol and Statistical Analysis Plan  [PDF] November 29, 2016

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Additional Information:

Resuscitation Outcomes Consortium (ROC) Public Homepage 

Responsible Party:	Henry E. Wang, MD, MS, Principal Investigator, University of Alabama at Birmingham
ClinicalTrials.gov Identifier:	NCT02419573 History of Changes
Other Study ID Numbers:	HL077863-PART; 5U01HL077863 ( U.S. NIH Grant/Contract ); UH2HL125163 ( U.S. NIH Grant/Contract )
First Posted:	April 17, 2015
Last Update Posted:	March 22, 2018
Last Verified:	March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:	No

Keywords provided by Henry E. Wang, MD, MS, University of Alabama at Birmingham:

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

Additional relevant MeSH terms:

Heart Arrest; Out-of-Hospital Cardiac Arrest; Heart Diseases; Cardiovascular Diseases