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LITES Task Order 0005 Prehospital Airway Control Trial (PACT) (PACT)

Primary Purpose

Trauma Injury, Airway Control

Status
Suspended
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Supraglottic airway device
Standard airway management
Sponsored by
Jason Sperry
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Trauma Injury focused on measuring intubation, supraglottic airway

Eligibility Criteria

15 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Traumatic injury requiring advanced airway management. Indicators of need for advanced airway management include: a) GCS<8, b) SpO2<90 despite supplemental oxygen, b) ETCO2>60 despite supplemental ventilation, or d) provider discretion.
  2. Transport (or intended transport) to an enrolling LITES Trauma Center

Exclusion Criteria:

  1. < 15 years of age
  2. Known pregnancy
  3. Known prisoner
  4. Initial advanced airway attempted by a non-PACT provider.
  5. Cardiac Arrest without return of spontaneous circulation (ROSC) at the time of the intervention
  6. Caustic substance ingestion
  7. Airway burns
  8. Objection to study voiced by subject or family member at the scene.

Inclusion and exclusion criteria will be assessed based on information available at the time of enrollment, defined as the time at which enrolling agency provides positive pressure ventilation support. Although all reasonable efforts will be made by the emergency medical crew to either directly witness or obtain documentation of inclusion criteria, due to the nature of the emergency prehospital setting, there may be occasions where the emergency medical crew must rely on verbal report of inclusion criteria from referring hospital or emergency crew. In these instances, if, after subsequent review of outside hospital and/or ground crew documentation, it is determined that the subject did not meet inclusion criteria and/or met exclusion criteria, the subject will remain enrolled in the study based on the intention-to-treat principle.

If a verbal report must be used in lieu of physical documentation or directly witnessing inclusion criteria, documentation of the verbal report will serve as the source documentation for determining eligibility. Verbal reports will be documented in the emergency medical record and will detail the information provided and by whom.

Sites / Locations

  • Emory University
  • Mount Sinai Hospital
  • Northwestern Memorial Hospital
  • John H. Stroger Hospital of Cook County
  • University of Chicago
  • University of Louisville
  • Tulane University
  • Washington University at St. Louis
  • East Carolina University
  • Oregon Health & Science University
  • Allegheny General Hospital
  • University of Pittsburgh
  • UPMC
  • Vanderbilt University

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Standard airway method arm

Supraglottic airway method arm

Arm Description

Standard airway management strategy

Supraglottic first airway management strategy

Outcomes

Primary Outcome Measures

24-hour survival

Secondary Outcome Measures

Proportion of subjects that survive to hospital discharge
Rate of first pass success of placement of advanced airway device
ICU length of stay
Ventilator days
Incidence of expected adverse events
Incidence of need for rescue airway device
Incidence of hypoxia
Incidence of hypotension

Full Information

First Posted
September 11, 2019
Last Updated
August 8, 2023
Sponsor
Jason Sperry
Collaborators
United States Department of Defense
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1. Study Identification

Unique Protocol Identification Number
NCT04100564
Brief Title
LITES Task Order 0005 Prehospital Airway Control Trial (PACT)
Acronym
PACT
Official Title
Prehospital Airway Control Trial : A Randomized Controlled Trial of Prehospital Airway Management Strategy for Trauma Patients
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Suspended
Why Stopped
Voluntarily suspended by Sponsor pending completion of interim analysis by DSMB
Study Start Date
April 1, 2021 (Actual)
Primary Completion Date
February 28, 2024 (Anticipated)
Study Completion Date
August 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Jason Sperry
Collaborators
United States Department of Defense

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The Prehospital Airway Control Trial (PACT) is a proposed 5 year, open label, multi-center, stepped-wedge randomized trial comparing airway management strategies of prehospital trauma patients. The initial airway attempt will be randomized to either usual care (control) or a supraglottic airway management approach (intervention). The primary outcome will be 24 hour survival, with secondary outcomes to include survival to hospital discharge, expected clinical adverse events, airway management performance, ICU length of stay, ventilator days, incidence of ARDS, and incidence of ventilator associated pneumonia. Subjects will be enrolled across approximately 17 prehospital agencies at select LITES Network sites and will enroll a total of 2,009 subjects.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Trauma Injury, Airway Control
Keywords
intubation, supraglottic airway

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Model Description
Stepped-wedge
Masking
None (Open Label)
Allocation
Randomized
Enrollment
2009 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Standard airway method arm
Arm Type
Active Comparator
Arm Description
Standard airway management strategy
Arm Title
Supraglottic airway method arm
Arm Type
Experimental
Arm Description
Supraglottic first airway management strategy
Intervention Type
Device
Intervention Name(s)
Supraglottic airway device
Other Intervention Name(s)
LMA, King, igel
Intervention Description
Initial advanced airway management with a supraglottic device
Intervention Type
Other
Intervention Name(s)
Standard airway management
Intervention Description
Initial advanced airway management with standard care method
Primary Outcome Measure Information:
Title
24-hour survival
Time Frame
From injury through 24 hours
Secondary Outcome Measure Information:
Title
Proportion of subjects that survive to hospital discharge
Time Frame
From hospital admission through death or hospital discharge up to 30 days
Title
Rate of first pass success of placement of advanced airway device
Time Frame
At time of placement of device through confirmation of device placement
Title
ICU length of stay
Time Frame
Admission through 30 days or discharge
Title
Ventilator days
Time Frame
Admission through 30 days or discharge
Title
Incidence of expected adverse events
Time Frame
From initial airway management through first 24 hours of hospital admission
Title
Incidence of need for rescue airway device
Time Frame
At the time of placement of device through time of arrival to trauma bay
Title
Incidence of hypoxia
Time Frame
At the time of placement of device through time of arrival to trauma bay
Title
Incidence of hypotension
Time Frame
At the time of placement of device through time of arrival to trauma bay

10. Eligibility

Sex
All
Minimum Age & Unit of Time
15 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Traumatic injury requiring advanced airway management. Indicators of need for advanced airway management include: a) GCS<8, b) SpO2<90 despite supplemental oxygen, b) ETCO2>60 despite supplemental ventilation, or d) provider discretion. Transport (or intended transport) to an enrolling LITES Trauma Center Exclusion Criteria: < 15 years of age Known pregnancy Known prisoner Initial advanced airway attempted by a non-PACT provider. Cardiac Arrest without return of spontaneous circulation (ROSC) at the time of the intervention Caustic substance ingestion Airway burns Objection to study voiced by subject or family member at the scene. Inclusion and exclusion criteria will be assessed based on information available at the time of enrollment, defined as the time at which enrolling agency provides positive pressure ventilation support. Although all reasonable efforts will be made by the emergency medical crew to either directly witness or obtain documentation of inclusion criteria, due to the nature of the emergency prehospital setting, there may be occasions where the emergency medical crew must rely on verbal report of inclusion criteria from referring hospital or emergency crew. In these instances, if, after subsequent review of outside hospital and/or ground crew documentation, it is determined that the subject did not meet inclusion criteria and/or met exclusion criteria, the subject will remain enrolled in the study based on the intention-to-treat principle. If a verbal report must be used in lieu of physical documentation or directly witnessing inclusion criteria, documentation of the verbal report will serve as the source documentation for determining eligibility. Verbal reports will be documented in the emergency medical record and will detail the information provided and by whom.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jason Sperry, MD, MPH
Organizational Affiliation
University of Pittsburgh
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Francis Guyette, MD, MPH
Organizational Affiliation
University of Pittsburgh
Official's Role
Principal Investigator
Facility Information:
Facility Name
Emory University
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30303
Country
United States
Facility Name
Mount Sinai Hospital
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60608
Country
United States
Facility Name
Northwestern Memorial Hospital
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
John H. Stroger Hospital of Cook County
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
University of Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Facility Name
University of Louisville
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40208
Country
United States
Facility Name
Tulane University
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70112
Country
United States
Facility Name
Washington University at St. Louis
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
East Carolina University
City
Greenville
State/Province
North Carolina
ZIP/Postal Code
27835
Country
United States
Facility Name
Oregon Health & Science University
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
Facility Name
Allegheny General Hospital
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15212
Country
United States
Facility Name
University of Pittsburgh
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
Facility Name
UPMC
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15261
Country
United States
Facility Name
Vanderbilt University
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37235
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

LITES Task Order 0005 Prehospital Airway Control Trial (PACT)

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