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Supraglottic airway device

Airway Management Techniques for Traumatic Injury (PACT Trial)

N/A

Recruiting

Led By Jason Sperry, MD, MPH

Research Sponsored by Jason Sperry

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Transport (or intended transport) to an enrolling LITES Trauma Center

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.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at the time of placement of device through time of arrival to trauma bay

Awards & highlights

PACT Trial Summary

This trial will compare airway management strategies of prehospital trauma patients to see which one is more effective.

Who is the study for?

The PACT trial is for trauma patients who need advanced help to breathe due to a low consciousness level, low oxygen levels despite extra oxygen, high carbon dioxide levels even with help breathing, or at the discretion of the healthcare provider. They must be going to a participating trauma center but can't join if they're pregnant, imprisoned, ingested caustic substances, have airway burns or are under 15.Check my eligibility

What is being tested?

This study compares two ways of managing breathing in trauma patients before reaching the hospital: usual care versus using a device that helps secure an open airway above the vocal cords. The main goal is to see which method keeps more people alive after 24 hours and until hospital discharge among other health outcomes.See study design

What are the potential side effects?

Possible side effects include expected issues like difficulty placing the airway device correctly or infections related to ventilation such as pneumonia. There may also be complications from improper ventilation leading to lung injury.

PACT Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am being taken to a LITES Trauma Center.

Select...

I needed advanced help to breathe due to a severe injury.

PACT Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at time of placement of device through confirmation of device placement

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at time of placement of device through confirmation of device placement

This trial's timeline: 3 weeks for screening, Varies for treatment, and at time of placement of device through confirmation of device placement for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

24-hour survival

Secondary outcome measures

ICU length of stay

Incidence of expected adverse events

Incidence of hypotension

+5 more

PACT Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Supraglottic airway method armExperimental Treatment1 Intervention

Supraglottic first airway management strategy

Group II: Standard airway method armActive Control1 Intervention

Standard airway management strategy

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Jason SperryLead Sponsor

8 Previous Clinical Trials

4,876 Total Patients Enrolled

United States Department of DefenseFED

865 Previous Clinical Trials

325,690 Total Patients Enrolled

Jason Sperry, MD, MPHPrincipal Investigator - University of Pittsburgh

Magee-Women's Hospital of UPMC, UPMC Presbyterian

Case Western Reserve University School Of Medicine (Medical School)

Johns Hopkins University School Medicine (Residency)

2 Previous Clinical Trials

492 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

In how many distinct geographic destinations is this experiment being conducted?

"This research study is currently being conducted in 14 medical centres distributed among Pittsburgh, Greenville, and New Orleans. To reduce travel burdens associated with participation, prospective enrollees should select the closest site to their home location."

Answered by AI

How many participants are currently participating in the trial?

"That is correct. The clinicaltrial.gov website indicates that this research project, which was first posted on April 1st 2021, is seeking out prospective participants. In total they need to recruit 2009 individuals from 14 sites around the world."

Answered by AI

Are there any opportunities to join this investigation currently?

"Affirmative. According to information on clinicaltrials.gov, this medical research is currently seeking out suitable participants; the trial was initially posted in April 2021 and edited most recently June 2022. It requires 2009 individuals at 14 different sites for participation."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

LITES Task Order 0005 Prehospital Airway Control Trial (PACT)

Jason Sperry 2021. "LITES Task Order 0005 Prehospital Airway Control Trial (PACT)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04100564.