Pragmatic Airway Resuscitation Trial

Not Applicable

Completed

• Conditions: Cardiac Arrest
• Interventions: Device: Laryngeal Tube (King); Device: Endotracheal Intubation

• Registration Number: NCT02419573
• Lead Sponsor: University of Alabama at Birmingham

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2015-02-25
• Study First Submitted QC: 2015-04-16
• Study First Posted: 2015-04-17
• Study Start: 2015-12-01
• Primary Completion: 2017-12-01
• Study Completion: 2017-12-01
• Results First Submitted: 2018-10-02
• Results First Submitted QC: 2018-11-17
• Status Verified: 2018-12
• Results First Posted: 2018-12-12
• Last Update Submitted: 2018-12-26
• Last Update Posted: 2019-01-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 3004

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.)

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Laryngeal Tube (King)	Laryngeal Tube (King)	Insertion of a supraglottic airway (SGA)
Endotracheal Intubation	Endotracheal Intubation	The insertion of a plastic breathing tube through the mouth and into the trachea.

Primary Outcome Measures

Name	Time	Method
Number of Patients Alive at 72 Hours After Episode.	72 hours	Number of patient alive at 72 hours after episode.

Secondary Outcome Measures

Name	Time	Method
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.	Presence of palpable pulses on Emergency Department arrival. Patients pronounced dead in the field coded as ROSC=\[none\].
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 alive at time hospital discharge.
Number of Patients With Favorable Neurologic Status on Hospital Discharge	From enrollment through end of hospital course.	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.

Trial Locations

Locations (6)

The Pittsburgh Resuscitation Network, University of Pittsburgh; 🇺🇸 Pittsburgh, Pennsylvania, United States

Portland Resuscitation Outcomes Consortium, Oregon Health & Sciences University; 🇺🇸 Portland, Oregon, United States

University of Washington (Data Coordinating Center); 🇺🇸 Seattle, Washington, United States

Alabama Resuscitation Center; 🇺🇸 Birmingham, Alabama, United States

Milwaukee Resuscitation Network, Medical College of Wisconsin; 🇺🇸 Milwaukee, Wisconsin, United States

Dallas Center for Resuscitation Research, University of Texas Southwestern Medical Cente; 🇺🇸 Dallas, Texas, United States