LITES Task Order 0005 Prehospital Airway Control Trial (PACT)

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

Status

Completed

Phases

Unknown

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04100564

Acronym

PACT

Enrollment

2010

Registered

2019-09-24

Start date

2021-04-01

Completion date

2026-04-07

Last updated

2026-04-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Airway Control, Trauma Injury

Keywords

intubation, supraglottic airway

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.

Interventions

DEVICESupraglottic airway device

Initial advanced airway management with a supraglottic device

OTHERStandard airway management

Initial advanced airway management with standard care method

Study design

Allocation

RANDOMIZED

Intervention model

SEQUENTIAL

Primary purpose

TREATMENT

Masking

NONE

Intervention model description

Stepped-wedge

Eligibility

Sex/Gender

ALL

Age

15 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame
24-hour survival	From injury through 24 hours

Secondary

Measure	Time frame
Proportion of subjects that survive to hospital discharge	From hospital admission through death or hospital discharge up to 30 days
Rate of first pass success of placement of advanced airway device	At time of placement of device through confirmation of device placement
ICU length of stay	Admission through 30 days or discharge
Ventilator days	Admission through 30 days or discharge
Incidence of expected adverse events	From initial airway management through first 24 hours of hospital admission
Incidence of need for rescue airway device	At the time of placement of device through time of arrival to trauma bay
Incidence of hypoxia	At the time of placement of device through time of arrival to trauma bay
Incidence of hypotension	At the time of placement of device through time of arrival to trauma bay

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORJason Sperry, MD, MPH

University of Pittsburgh

PRINCIPAL_INVESTIGATORFrancis Guyette, MD, MPH