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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
Last Update Posted : March 22, 2018
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

February 25, 2015
April 17, 2015
March 22, 2018
December 1, 2015
December 1, 2017   (Final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT02419573 on ClinicalTrials.gov Archive Site
  • 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 ]
  • 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 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. ]
    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 ]
Not Provided
Not Provided
 
Pragmatic Airway Resuscitation Trial
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.

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.

Interventional
Not Applicable
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Cardiac Arrest
  • 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.
  • 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)
  • Active Comparator: Endotracheal Intubation
    The insertion of a plastic breathing tube through the mouth and into the trachea.
    Intervention: Device: Endotracheal Intubation
  • Active Comparator: Laryngeal Tube (King)
    Insertion of a supraglottic airway (SGA)
    Intervention: Device: Laryngeal Tube (King)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
3005
3000
December 1, 2017
December 1, 2017   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT02419573
HL077863-PART
5U01HL077863 ( U.S. NIH Grant/Contract )
UH2HL125163 ( U.S. NIH Grant/Contract )
Yes
Not Provided
Plan to Share IPD: No
Henry E. Wang, MD, MS, University of Alabama at Birmingham
University of Alabama at Birmingham
  • National Heart, Lung, and Blood Institute (NHLBI)
  • American Heart Association
  • The University of Texas Health Science Center, Houston
Principal Investigator: Henry E Wang, MD University of Alabama, University of Texas Health Science Center at Houston
University of Alabama at Birmingham
March 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP