Pragmatic Airway Resuscitation Trial (PART)
|Study Design:||Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: No masking
Primary Purpose: Treatment
|Official Title:||Pragmatic Trial of Airway Management in Out-of-Hospital Cardiac Arrest|
- 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.
- 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 ]
|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)|
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.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT02419573
|Contact: Karen N Brown, MSHAfirstname.lastname@example.org|
|Contact: Judy Powellemail@example.com|
|United States, Alabama|
|Alabama Resuscitation Center||Recruiting|
|Birmingham, Alabama, United States, 35294|
|Contact: Henry Wang, MD firstname.lastname@example.org|
|United States, Oregon|
|Portland Resuscitation Outcomes Consortium, Oregon Health & Sciences University||Recruiting|
|Portland, Oregon, United States, 92739|
|Contact: Mohamud Daya, MD email@example.com|
|United States, Pennsylvania|
|The Pittsburgh Resuscitation Network, University of Pittsburgh||Recruiting|
|Pittsburgh, Pennsylvania, United States, 15261|
|Contact: Clif Callaway, MD 412-647-9047 firstname.lastname@example.org|
|United States, Texas|
|Dallas Center for Resuscitation Research, University of Texas Southwestern Medical Cente||Recruiting|
|Dallas, Texas, United States, 75390|
|Contact: Ahamed Idris, MD email@example.com|
|United States, Wisconsin|
|Milwaukee Resuscitation Network, Medical College of Wisconsin||Recruiting|
|Milwaukee, Wisconsin, United States, 53226|
|Contact: Tom Aufderheide, MD 414-805-6452 firstname.lastname@example.org|
|Principal Investigator:||Henry E Wang, MD||University of Alabama at Birmingham|