Pragmatic Airway Resuscitation Trial (PART)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02419573|
Recruitment Status : Completed
First Posted : April 17, 2015
Last Update Posted : March 22, 2018
|Condition or disease||Intervention/treatment||Phase|
|Cardiac Arrest||Device: Endotracheal Intubation Device: Laryngeal Tube (King)||Not Applicable|
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 (Clinical Trial)|
|Actual Enrollment :||3005 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||None (Open Label)|
|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|
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.
- 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 ]
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
|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|
|Principal Investigator:||Henry E Wang, MD||University of Alabama, University of Texas Health Science Center at Houston|