N/A
N=3,004
Pragmatic Airway Resuscitation Trial
Cardiac Arrest
Bottom Line
View on ClinicalTrials.gov: NCT02419573 ↗Enrolled (actual)
3,004
Serious AEs
0.0%
Results posted
Dec 2018
Primary outcome: Primary: Number of Patients Alive at 72 Hours After Episode. — 230; 275 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Endotracheal Intubation (Device); Laryngeal Tube (King) (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Alabama at Birmingham
- Primary completion
- Dec 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Patients Alive at 72 Hours After Episode. |
230; 275 | — |
| SECONDARY Return of Spontaneous Circulation (ROSC) |
361; 420 | — |
| SECONDARY Number of Patients Alive at Hospital Discharge |
121; 163 | — |
| SECONDARY Number of Patients With Favorable Neurologic Status on Hospital Discharge |
75; 107 | — |
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.
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
- Inter-facility transports
- Patients with a "do not enroll" bracelet
Data sourced from ClinicalTrials.gov (NCT02419573). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.