Pragmatic Airway Resuscitation Trial (PART)

December 26, 2018 updated by: Henry E. Wang, MD, MS, University of Alabama at Birmingham

Pragmatic Trial of Airway Management in Out-of-Hospital Cardiac Arrest

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

3004

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Patients Alive at 72 Hours After Episode.
Time Frame: 72 hours
Number of patient alive at 72 hours after episode.
72 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Presence of palpable pulses on Emergency Department arrival. Patients pronounced dead in the field coded as ROSC=[none].
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
Time Frame: From enrollment through end of hospital course. Maximum time interval not specified. Maximum time interval observed in study was 138 days.
Number of patients alive at time 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
Time Frame: From enrollment through end of hospital course.

Number of patients with favorable neurologic status, defined as Modified Rankin Scale (MRS) <=3.

MRS values for neurologic outcome include:

0 - No symptoms.

  1. - No significant disability. Able to carry out all usual activities, despite some symptoms.
  2. - Slight disability. Able to look after own affairs without assistance, but unable to carry out all previous activities.
  3. - Moderate disability. Requires some help, but able to walk unassisted.
  4. - Moderately severe disability. Unable to attend to own bodily needs without assistance, and unable to walk unassisted.
  5. - Severe disability. Requires constant nursing care and attention, bedridden, incontinent.
  6. - Dead.
From enrollment through end of hospital course.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Alabama at Birmingham

Collaborators

The University of Texas Health Science Center, Houston
National Heart, Lung, and Blood Institute (NHLBI)
American Heart Association

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2015

Primary Completion (Actual)

December 1, 2017

Study Completion (Actual)

December 1, 2017

Study Registration Dates

First Submitted

February 25, 2015

First Submitted That Met QC Criteria

April 16, 2015

First Posted (Estimate)

April 17, 2015

Study Record Updates

Last Update Posted (Actual)

January 14, 2019

Last Update Submitted That Met QC Criteria

December 26, 2018

Last Verified

December 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HL077863-PART
  • 5U01HL077863 (U.S. NIH Grant/Contract)
  • UH2HL125163 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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