Pragmatic Airway Resuscitation Trial

N/ACompletedNCT02419573

University of Alabama at Birmingham3,004 enrolled

Overview

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

3,004

Conditions

Cardiac Arrest

Interventions

Endotracheal IntubationDEVICE

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.

Laryngeal Tube (King)DEVICE

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (6)

Alabama Resuscitation Center

Birmingham, Alabama, United States

Portland Resuscitation Outcomes Consortium, Oregon Health & Sciences University

Portland, Oregon, United States

The Pittsburgh Resuscitation Network, University of Pittsburgh

Pittsburgh, Pennsylvania, United States

Dallas Center for Resuscitation Research, University of Texas Southwestern Medical Cente

Outcomes

Primary Outcomes

Number of Patients Alive at 72 Hours After Episode.

Number of patient alive at 72 hours after episode.

Time frame: 72 hours

Secondary Outcomes

Return of Spontaneous Circulation (ROSC)

Presence of palpable pulses on Emergency Department arrival. Patients pronounced dead in the field coded as ROSC=\[none\].

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.

Number of Patients Alive at Hospital Discharge

Number of patients alive at time 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 With Favorable Neurologic Status on Hospital Discharge

Number of patients with favorable neurologic status, defined as Modified Rankin Scale (MRS) \<=3. MRS values for neurologic outcome include: 0 - No symptoms. 1. \- No significant disability. Able to carry out all usual activities, despite some symptoms. 2. \- Slight disability. Able to look after own affairs without assistance, but unable to carry out all previous activities. 3. \- Moderate disability. Requires some help, but able to walk unassisted. 4. \- Moderately severe disability. Unable to attend to own bodily needs without assistance, and unable to walk unassisted. 5. \- Severe disability. Requires constant nursing care and attention, bedridden, incontinent. 6. \- Dead.

Time frame: From enrollment through end of hospital course.

Data from ClinicalTrials.gov

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