Clinical trial NCT02419573: Pragmatic Airway Resuscitation Trial
Official title: Pragmatic Trial of Airway Management in Out-of-Hospital Cardiac Arrest
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiac Arrest
Keywords: cardiac arrest
cardiopulmonary resuscitation
laryngeal tube
endotracheal intubation
non-traumatic Out of Hospital Cardiac Arrest (OOHCA)
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
name: American Heart Association
name: The University of Texas Health Science Center, Houston
First posted: 2015-04-17
Enrollment: 3004
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Number of Patients Alive at 72 Hours After Episode.
timeFrame: 72 hours
Secondary outcomes:
measure: Return of Spontaneous Circulation (ROSC)
timeFrame: 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.
measure: Number of Patients Alive at Hospital Discharge
timeFrame: From enrollment through end of hospital course. Maximum time interval not specified. Maximum time interval observed in study was 138 days.
measure: Number of Patients With Favorable Neurologic Status on Hospital Discharge
timeFrame: From enrollment through end of hospital course.
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Alabama Resuscitation Center
state: Alabama
city: Portland
country: United States
facility: Portland Resuscitation Outcomes Consortium, Oregon Health & Sciences University
state: Oregon
city: Pittsburgh
country: United States
facility: The Pittsburgh Resuscitation Network, University of Pittsburgh
state: Pennsylvania
city: Dallas
country: United States
facility: Dallas Center for Resuscitation Research, University of Texas Southwestern Medical Cente
state: Texas
city: Seattle
country: United States
facility: University of Washington (Data Coordinating Center)
state: Washington
city: Milwaukee
country: United States
facility: Milwaukee Resuscitation Network, Medical College of Wisconsin
state: Wisconsin
Study officials:
affiliation: University of Alabama, University of Texas Health Science Center at Houston
name: Henry E Wang, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Wang HE, Humbert A, Nichol G, Carlson JN, Daya MR, Radecki RP, Hansen M, Callaway CW, Pedroza C. Bayesian Analysis of the Pragmatic Airway Resuscitation Trial. Ann Emerg Med. 2019 Dec;74(6):809-817. doi: 10.1016/j.annemergmed.2019.05.009. Epub 2019 Jul 2.
citation: Wang HE, Schmicker RH, Daya MR, Stephens SW, Idris AH, Carlson JN, Colella MR, Herren H, Hansen M, Richmond NJ, Puyana JCJ, Aufderheide TP, Gray RE, Gray PC, Verkest M, Owens PC, Brienza AM, Sternig KJ, May SJ, Sopko GR, Weisfeldt ML, Nichol G. Effect of a Strategy of Initial Laryngeal Tube Insertion vs Endotracheal Intubation on 72-Hour Survival in Adults With Out-of-Hospital Cardiac Arrest: A Randomized Clinical Trial. JAMA. 2018 Aug 28;320(8):769-778. doi: 10.1001/jama.2018.7044.