Pragmatic Airway Resuscitation Trial (PART)

The University of Alabama at Birmingham

Status: Completed

Conditions: Cardiac Arrest

Treatments: Device: Endotracheal Intubation; Device: Laryngeal Tube (King)

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT02419573

HL077863-PART

UH2HL125163 (U.S. NIH Grant/Contract)

5U01HL077863 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 3,004 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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3,004 participants in 2 patient groups

Endotracheal Intubation

Active Comparator group

Description:

The insertion of a plastic breathing tube through the mouth and into the trachea.

Treatment:

Device: Endotracheal Intubation

Laryngeal Tube (King)

Active Comparator group

Description:

Insertion of a supraglottic airway (SGA)

Treatment:

Device: Laryngeal Tube (King)