Pragmatic Airway Resuscitation Trial (PART)

• ClinicalTrials.gov Identifier: NCT02419573
• Recruitment Status: Completed
• First Posted: April 17, 2015
• Results First Posted: December 12, 2018
• Last Update Posted: January 14, 2019
• Sponsor: University of Alabama at Birmingham
• Collaborators: National Heart, Lung, and Blood Institute (NHLBI); American Heart Association; The University of Texas Health Science Center, Houston
• Information provided by (Responsible Party): Henry E. Wang, MD, MS, University of Alabama at Birmingham

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Cardiac Arrest	Device: Endotracheal Intubation; Device: Laryngeal Tube (King)	Not Applicable

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 3004 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Pragmatic Trial of Airway Management in Out-of-Hospital Cardiac Arrest
• Actual Study Start Date: December 1, 2015
• Actual Primary Completion Date: December 1, 2017
• Actual Study Completion Date: December 1, 2017

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: Endotracheal Intubation; The insertion of a plastic breathing tube through the mouth and into the trachea.	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.
Active Comparator: Laryngeal Tube (King); Insertion of a supraglottic airway (SGA)	Device: 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.; Other Names: King (LT-D); King (LTS-D); King (LT)

Outcome Measures

Primary Outcome Measures :

1. Number of Patients Alive at 72 Hours After Episode. [ Time Frame: 72 hours ]
   Number of patient alive at 72 hours after episode.

Secondary Outcome Measures :

1. Return of Spontaneous Circulation (ROSC) [ 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. ]
   Presence of palpable pulses on Emergency Department arrival. Patients pronounced dead in the field coded as ROSC=[none].
2. Number of Patients Alive at 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 alive at time hospital discharge.
3. Number of Patients With Favorable Neurologic Status on Hospital Discharge [ Time Frame: 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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

United States, Alabama

Alabama Resuscitation Center

Birmingham, Alabama, United States, 35294

United States, Oregon

Portland Resuscitation Outcomes Consortium, Oregon Health & Sciences University

Portland, Oregon, United States, 92739

United States, Pennsylvania

The Pittsburgh Resuscitation Network, University of Pittsburgh

Pittsburgh, Pennsylvania, United States, 15261

United States, Texas

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

Dallas, Texas, United States, 75390

United States, Washington

University of Washington (Data Coordinating Center)

Seattle, Washington, United States, 98115

United States, Wisconsin

Milwaukee Resuscitation Network, Medical College of Wisconsin

Milwaukee, Wisconsin, United States, 53226

Sponsors and Collaborators

University of Alabama at Birmingham

National Heart, Lung, and Blood Institute (NHLBI)

American Heart Association

The University of Texas Health Science Center, Houston

Investigators

• Principal Investigator: Henry E Wang, MD; University of Alabama, University of Texas Health Science Center at Houston

  Study Documents (Full-Text)

Documents provided by Henry E. Wang, MD, MS, University of Alabama at Birmingham:

Study Protocol and Statistical Analysis Plan  [PDF] November 29, 2016

More Information

Additional Information:

Resuscitation Outcomes Consortium (ROC) Public Homepage 

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

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.

• Responsible Party: Henry E. Wang, MD, MS, Principal Investigator, University of Alabama at Birmingham
• ClinicalTrials.gov Identifier: NCT02419573
• Other Study ID Numbers: HL077863-PART; 5U01HL077863 ( U.S. NIH Grant/Contract ); UH2HL125163 ( U.S. NIH Grant/Contract )
• First Posted: April 17, 2015
• Results First Posted: December 12, 2018
• Last Update Posted: January 14, 2019
• Last Verified: December 2018

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

Keywords provided by Henry E. Wang, MD, MS, University of Alabama at Birmingham:

cardiac arrest; cardiopulmonary resuscitation; laryngeal tube; endotracheal intubation; non-traumatic Out of Hospital Cardiac Arrest (OOHCA)

Additional relevant MeSH terms:

Heart Arrest; Out-of-Hospital Cardiac Arrest; Heart Diseases; Cardiovascular Diseases