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Pragmatic Airway Resuscitation Trial (PART)

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ClinicalTrials.gov Identifier: NCT02419573
Recruitment Status : Completed
First Posted : April 17, 2015
Results First Posted : December 12, 2018
Last Update Posted : January 14, 2019
Sponsor:
Collaborators:
National Heart, Lung, and Blood Institute (NHLBI)
American Heart Association
The University of Texas Health Science Center, Houston
Information provided by (Responsible Party):
Henry E. Wang, MD, MS, University of Alabama at Birmingham

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 : 3004 participants
Allocation: Randomized
Intervention Model: Parallel 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

Resource links provided by the National Library of Medicine


Arms and Interventions
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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. Number of Patients Alive at 72 Hours After Episode. [ Time Frame: 72 hours ]
    Number of patient alive at 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. ]
    Presence of palpable pulses on Emergency Department arrival. Patients pronounced dead in the field coded as ROSC=[none].

  2. 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.

  3. 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02419573


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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Additional Information:
Resuscitation Outcomes Consortium (ROC) Public Homepage  This link exits the ClinicalTrials.gov site

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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    Key Record Dates
Results First Posted: December 12, 2018
Last Update Posted: January 14, 2019
Last Verified: December 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