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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

Tracking Information
First Submitted Date  ICMJE February 25, 2015
First Posted Date  ICMJE April 17, 2015
Results First Submitted Date  ICMJE October 2, 2018
Results First Posted Date  ICMJE December 12, 2018
Last Update Posted Date January 14, 2019
Actual Study Start Date  ICMJE December 1, 2015
Actual Primary Completion Date December 1, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 17, 2018)
Number of Patients Alive at 72 Hours After Episode. [ Time Frame: 72 hours ]
Number of patient alive at 72 hours after episode.
Original Primary Outcome Measures  ICMJE
 (submitted: April 16, 2015)
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.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 26, 2018)
  • 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].
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: April 16, 2015)
  • 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 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Pragmatic Airway Resuscitation Trial
Official Title  ICMJE Pragmatic Trial of Airway Management in Out-of-Hospital Cardiac Arrest
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.
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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Cardiac Arrest
Intervention  ICMJE
  • 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)
Study Arms  ICMJE
  • 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)
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 17, 2018)
3004
Original Estimated Enrollment  ICMJE
 (submitted: April 16, 2015)
3000
Actual Study Completion Date  ICMJE December 1, 2017
Actual Primary Completion Date December 1, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02419573
Other Study ID Numbers  ICMJE HL077863-PART
5U01HL077863 ( U.S. NIH Grant/Contract )
UH2HL125163 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Henry E. Wang, MD, MS, University of Alabama at Birmingham
Study Sponsor  ICMJE University of Alabama at Birmingham
Collaborators  ICMJE
  • National Heart, Lung, and Blood Institute (NHLBI)
  • American Heart Association
  • The University of Texas Health Science Center, Houston
Investigators  ICMJE
Principal Investigator: Henry E Wang, MD University of Alabama, University of Texas Health Science Center at Houston
PRS Account University of Alabama at Birmingham
Verification Date December 2018

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