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Pragmatic Airway Resuscitation Trial (PART)

Primary Purpose

Cardiac Arrest

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Endotracheal Intubation
Laryngeal Tube (King)
Sponsored by
University of Alabama at Birmingham
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cardiac Arrest focused on measuring cardiac arrest, cardiopulmonary resuscitation, laryngeal tube, endotracheal intubation, non-traumatic Out of Hospital Cardiac Arrest (OOHCA)

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Alabama Resuscitation Center
  • Portland Resuscitation Outcomes Consortium, Oregon Health & Sciences University
  • The Pittsburgh Resuscitation Network, University of Pittsburgh
  • Dallas Center for Resuscitation Research, University of Texas Southwestern Medical Cente
  • University of Washington (Data Coordinating Center)
  • Milwaukee Resuscitation Network, Medical College of Wisconsin

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Endotracheal Intubation

Laryngeal Tube (King)

Arm Description

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

Insertion of a supraglottic airway (SGA)

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Return of Spontaneous Circulation (ROSC)
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
Number of patients alive at time hospital discharge.
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.

Full Information

First Posted
February 25, 2015
Last Updated
December 26, 2018
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
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1. Study Identification

Unique Protocol Identification Number
NCT02419573
Brief Title
Pragmatic Airway Resuscitation Trial
Acronym
PART
Official Title
Pragmatic Trial of Airway Management in Out-of-Hospital Cardiac Arrest
Study Type
Interventional

2. Study Status

Record Verification Date
December 2018
Overall Recruitment Status
Completed
Study Start Date
December 1, 2015 (Actual)
Primary Completion Date
December 1, 2017 (Actual)
Study Completion Date
December 1, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the 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

4. Oversight

Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiac Arrest
Keywords
cardiac arrest, cardiopulmonary resuscitation, laryngeal tube, endotracheal intubation, non-traumatic Out of Hospital Cardiac Arrest (OOHCA)

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
3004 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Endotracheal Intubation
Arm Type
Active Comparator
Arm Description
The insertion of a plastic breathing tube through the mouth and into the trachea.
Arm Title
Laryngeal Tube (King)
Arm Type
Active Comparator
Arm Description
Insertion of a supraglottic airway (SGA)
Intervention Type
Device
Intervention Name(s)
Endotracheal Intubation
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Laryngeal Tube (King)
Other Intervention Name(s)
King (LT-D), King (LTS-D), King (LT)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Number of Patients Alive at 72 Hours After Episode.
Description
Number of patient alive at 72 hours after episode.
Time Frame
72 hours
Secondary Outcome Measure Information:
Title
Return of Spontaneous Circulation (ROSC)
Description
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.
Title
Number of Patients Alive at Hospital Discharge
Description
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.
Title
Number of Patients With Favorable Neurologic Status on Hospital Discharge
Description
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.
Time Frame
From enrollment through end of hospital course.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Henry E Wang, MD
Organizational Affiliation
University of Alabama, University of Texas Health Science Center at Houston
Official's Role
Principal Investigator
Facility Information:
Facility Name
Alabama Resuscitation Center
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States
Facility Name
Portland Resuscitation Outcomes Consortium, Oregon Health & Sciences University
City
Portland
State/Province
Oregon
ZIP/Postal Code
92739
Country
United States
Facility Name
The Pittsburgh Resuscitation Network, University of Pittsburgh
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15261
Country
United States
Facility Name
Dallas Center for Resuscitation Research, University of Texas Southwestern Medical Cente
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390
Country
United States
Facility Name
University of Washington (Data Coordinating Center)
City
Seattle
State/Province
Washington
ZIP/Postal Code
98115
Country
United States
Facility Name
Milwaukee Resuscitation Network, Medical College of Wisconsin
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
31272823
Citation
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.
Results Reference
derived
PubMed Identifier
30167699
Citation
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.
Results Reference
derived
Links:
URL
http://roc.uwctc.org
Description
Resuscitation Outcomes Consortium (ROC) Public Homepage

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Pragmatic Airway Resuscitation Trial

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