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
|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 :||3004 participants|
|Intervention Model:||Parallel 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.
- Number of Patients Alive at 72 Hours After Episode. [ Time Frame: 72 hours ]Number of patient alive at 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. ]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.
- - No significant disability. Able to carry out all usual activities, despite some symptoms.
- - Slight disability. Able to look after own affairs without assistance, but unable to carry out all previous activities.
- - Moderate disability. Requires some help, but able to walk unassisted.
- - Moderately severe disability. Unable to attend to own bodily needs without assistance, and unable to walk unassisted.
- - Severe disability. Requires constant nursing care and attention, bedridden, incontinent.
- - Dead.
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|