Pragmatic Airway Resuscitation Trial

Cardiac Arrest Clinical Trial

— PART  

Official title:

Pragmatic Trial of Airway Management in Out-of-Hospital Cardiac Arrest

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02419573
• Other study ID #: HL077863-PART
• Secondary ID: 5U01HL077863UH2H
• Status: Completed
• Phase: N/A
• Start date: December 1, 2015
• Est. completion date: December 1, 2017

Study information

• Verified date: December 2018
• Source: University of Alabama at Birmingham
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3004
• Est. completion date: December 1, 2017
• Est. primary completion date: December 1, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cardiac Arrest
• Heart Arrest
• Out-of-Hospital Cardiac Arrest

Intervention

Device:
• Endotracheal Intubation
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)
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.

Locations

Country	Name	City	State
United States	Alabama Resuscitation Center	Birmingham	Alabama
United States	Dallas Center for Resuscitation Research, University of Texas Southwestern Medical Cente	Dallas	Texas
United States	Milwaukee Resuscitation Network, Medical College of Wisconsin	Milwaukee	Wisconsin
United States	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

Sponsors (4)

Lead Sponsor	Collaborator
University of Alabama at Birmingham	American Heart Association, National Heart, Lung, and Blood Institute (NHLBI), The University of Texas Health Science Center, Houston

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Patients Alive at 72 Hours After Episode.	Number of patient alive at 72 hours after episode.	72 hours
Secondary	Return of Spontaneous Circulation (ROSC)	Presence of palpable pulses on Emergency Department arrival. Patients pronounced dead in the field coded as ROSC=[none].	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.
Secondary	Number of Patients Alive at Hospital Discharge	Number of patients alive at time hospital discharge.	From enrollment through end of hospital course. Maximum time interval not specified. Maximum time interval observed in study was 138 days.
Secondary	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.; - No significant disability. Able to carry out all usual activities, despite some symptoms.; - Slight disability. Able to look after own affairs without assistance, but unable to carry out all previous activities.; - Moderate disability. Requires some help, but able to walk unassisted.; - Moderately severe disability. Unable to attend to own bodily needs without assistance, and unable to walk unassisted.; - Severe disability. Requires constant nursing care and attention, bedridden, incontinent.; - Dead.	From enrollment through end of hospital course.

External Links

•   Resuscitation Outcomes Consortium (ROC) Public Homepage