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Pragmatic Airway Resuscitation Trial (PART)

This study is currently recruiting participants.
See Contacts and Locations
Verified March 2017 by Henry E. Wang, MD, MS, University of Alabama at Birmingham
Sponsor:
Collaborators:
National Heart, Lung, and Blood Institute (NHLBI)
American Heart Association
Information provided by (Responsible Party):
Henry E. Wang, MD, MS, University of Alabama at Birmingham
ClinicalTrials.gov Identifier:
NCT02419573
First received: February 25, 2015
Last updated: March 30, 2017
Last verified: March 2017
  Purpose
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 Intervention
Cardiac Arrest Device: Endotracheal Intubation Device: Laryngeal Tube (King)

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Henry E. Wang, MD, MS, University of Alabama at Birmingham:

Primary Outcome Measures:
  • 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:
  • 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

  • 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

  • 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 ]

Estimated Enrollment: 3000
Study Start Date: December 2015
Estimated Study Completion Date: November 2020
Estimated Primary Completion Date: September 2020 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)

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.

  Eligibility

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.d 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02419573

Contacts
Contact: Karen N Brown, MSHA 205-975-2393 karenbrown@uabmc.edu
Contact: Judy Powell 800-332-0586 jlpowell@uw.edu

Locations
United States, Alabama
Alabama Resuscitation Center Recruiting
Birmingham, Alabama, United States, 35294
Contact: Henry Wang, MD       hwang@uabmc.edu   
United States, Oregon
Portland Resuscitation Outcomes Consortium, Oregon Health & Sciences University Recruiting
Portland, Oregon, United States, 92739
Contact: Mohamud Daya, MD       dayam@ohsu.edu   
United States, Pennsylvania
The Pittsburgh Resuscitation Network, University of Pittsburgh Recruiting
Pittsburgh, Pennsylvania, United States, 15261
Contact: Clif Callaway, MD    412-647-9047    callawaycw@upmc.edu   
United States, Texas
Dallas Center for Resuscitation Research, University of Texas Southwestern Medical Cente Recruiting
Dallas, Texas, United States, 75390
Contact: Ahamed Idris, MD       aidris@sbcglobal.net   
United States, Wisconsin
Milwaukee Resuscitation Network, Medical College of Wisconsin Recruiting
Milwaukee, Wisconsin, United States, 53226
Contact: Tom Aufderheide, MD    414-805-6452    taufderh@mcw.edu   
Sponsors and Collaborators
University of Alabama at Birmingham
National Heart, Lung, and Blood Institute (NHLBI)
American Heart Association
Investigators
Principal Investigator: Henry E Wang, MD University of Alabama at Birmingham
  More Information

Additional Information:
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 )
Study First Received: February 25, 2015
Last Updated: March 30, 2017
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

ClinicalTrials.gov processed this record on August 23, 2017