Pragmatic Trial of Airway Management in Out-of-Hospital Cardiac Arrest
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Cardiac Arrest
- Sponsor
- University of Alabama at Birmingham
- Enrollment
- 3004
- Locations
- 6
- Primary Endpoint
- Number of Patients Alive at 72 Hours After Episode.
- Status
- Completed
- Last Updated
- 7 years ago
Overview
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.
Investigators
Henry E. Wang, MD, MS
Principal Investigator
University of Alabama at Birmingham
Eligibility Criteria
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
Outcomes
Primary Outcomes
Number of Patients Alive at 72 Hours After Episode.
Time Frame: 72 hours
Number of patient alive at 72 hours after episode.
Secondary Outcomes
- Return of Spontaneous Circulation (ROSC)(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.)
- Number of Patients Alive at Hospital Discharge(From enrollment through end of hospital course. Maximum time interval not specified. Maximum time interval observed in study was 138 days.)
- Number of Patients With Favorable Neurologic Status on Hospital Discharge(From enrollment through end of hospital course.)