RECRUITING

LITES Task Order 0005 Prehospital Airway Control Trial (PACT)

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Prehospital Airway Control Trial : A Randomized Controlled Trial of Prehospital Airway Management Strategy for Trauma Patients

Quick Facts

Study Start:2021-04-01
Study Completion:2026-03-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04100564

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:15 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD, ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 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. 2. Transport (or intended transport) to an enrolling LITES Trauma Center
  1. 1. \< 15 years of age
  2. 2. Known pregnancy
  3. 3. Known prisoner
  4. 4. Initial advanced airway attempted by a non-PACT provider.
  5. 5. Cardiac Arrest without return of spontaneous circulation (ROSC) at the time of the intervention
  6. 6. Caustic substance ingestion
  7. 7. Airway burns
  8. 8. Objection to study voiced by subject or family member at the scene.

Contacts and Locations

Study Contact

Jason Sperry, MD, MPH
CONTACT
412 802 8270
sperryjl@upmc.edu

Principal Investigator

Jason Sperry, MD, MPH
PRINCIPAL_INVESTIGATOR
University of Pittsburgh
Francis Guyette, MD, MPH
PRINCIPAL_INVESTIGATOR
University of Pittsburgh

Study Locations (Sites)

Emory University
Atlanta, Georgia, 30303
United States
Mount Sinai Hospital
Chicago, Illinois, 60608
United States
Northwestern Memorial Hospital
Chicago, Illinois, 60611
United States
John H. Stroger Hospital of Cook County
Chicago, Illinois, 60612
United States
University of Chicago
Chicago, Illinois, 60637
United States
University of Louisville
Louisville, Kentucky, 40208
United States
Tulane University
New Orleans, Louisiana, 70112
United States
Washington University at St. Louis
Saint Louis, Missouri, 63110
United States
East Carolina University
Greenville, North Carolina, 27835
United States
Oregon Health & Science University
Portland, Oregon, 97239
United States
Allegheny General Hospital
Pittsburgh, Pennsylvania, 15212
United States
University of Pittsburgh
Pittsburgh, Pennsylvania, 15213
United States
UPMC
Pittsburgh, Pennsylvania, 15261
United States
Vanderbilt University
Nashville, Tennessee, 37235
United States

Collaborators and Investigators

Sponsor: Jason Sperry

  • Jason Sperry, MD, MPH, PRINCIPAL_INVESTIGATOR, University of Pittsburgh
  • Francis Guyette, MD, MPH, PRINCIPAL_INVESTIGATOR, University of Pittsburgh

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-04-01
Study Completion Date2026-03-31

Study Record Updates

Study Start Date2021-04-01
Study Completion Date2026-03-31

Terms related to this study

Keywords Provided by Researchers

  • intubation
  • supraglottic airway

Additional Relevant MeSH Terms

  • Trauma Injury
  • Airway Control