Airway Management Techniques for Traumatic Injury

(PACT Trial)

Recruiting in Palo Alto (17 mi)

+13 other locations

Overseen by Jason Sperry, MD, MPH

Age: Any Age

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Jason Sperry

Disqualifiers: Under 15, Pregnancy, Prisoner, others

No Placebo Group

Approved in 2 Jurisdictions

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It focuses on airway management for traumatic injuries, so it's best to discuss your medications with the trial team.

What data supports the effectiveness of this treatment for traumatic injury?

Research shows that supraglottic airway devices like the i-gel are reliable, efficient, and safe for airway management in both children and adults, making them useful in situations where managing the airway is challenging. ^{1 2 3 4 5}

Is the i-gel supraglottic airway device safe for use in humans?

Research shows that the i-gel supraglottic airway device is considered safe for airway management in both children and adults, as it has been found to be reliable and efficient in previous studies. ^{2 5 6 7 8}

How is the supraglottic airway device treatment different from other treatments for traumatic injury?

The supraglottic airway device (SGA), like the i-gel, is unique because it provides a non-invasive way to manage airways without needing to insert a tube into the trachea (windpipe). It features a gel-like cuff that doesn't require inflation, making it easier and quicker to use in emergencies, and it includes a channel for a gastric tube to help manage stomach contents. ^{4 5 8 9 10}

Research Team

Jason Sperry, MD, MPH

Principal Investigator

University of Pittsburgh

Francis Guyette, MD, MPH

Principal Investigator

University of Pittsburgh

Eligibility Criteria

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.

Inclusion Criteria

I am being taken to a LITES Trauma Center.

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

Exclusion Criteria

I or a family member have expressed concerns about participating in the study.

Known prisoner

I have ingested a caustic substance.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either usual care or a supraglottic airway management approach

Immediate intervention upon enrollment

Follow-up

Participants are monitored for survival to hospital discharge and other secondary outcomes

Until hospital discharge

Long-term follow-up

Monitoring of ICU length of stay, ventilator days, incidence of ARDS, and incidence of ventilator associated pneumonia

Up to 5 years

Treatment Details

Interventions

• Standard airway management (Other)
• Supraglottic airway device (Supraglottic airway device)

Trial Overview 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.

Participant Groups

Group I: Supraglottic airway method arm Experimental Treatment 1 Intervention

Supraglottic first airway management strategy

Group II: Standard airway method arm Active Control 1 Intervention

Standard airway management strategy

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Emory University Atlanta, GA

University of Pittsburgh Pittsburgh, PA

Mount Sinai Hospital Chicago, IL

Allegheny General Hospital Pittsburgh, PA

More Trial Locations

Who Is Running the Clinical Trial?

Jason Sperry

Lead Sponsor

Trials

9

Patients Recruited

6,900+

United States Department of Defense

Collaborator

Trials

940

Patients Recruited

339,000+

Findings from Research

The i-gel™ device allows for significantly faster insertion compared to the LMA-Classic™, making it advantageous in emergency situations where time is critical.

Both devices showed similar safety profiles with no significant differences in postoperative complications or airway leak, suggesting that i-gel™ is a viable alternative for controlled ventilation during anesthesia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of i-gel™ and laryngeal mask airway in anesthetized paralyzed patients. Reza Hashemian, SM., Nouraei, N., Razavi, SS., et al.[2022]

The I-gelTM supraglottic airway demonstrated significantly higher oropharyngeal leak pressures (27.97 cm H2O) compared to the BlockbusterTM LMA (26.04 cm H2O), indicating better performance for positive pressure ventilation in pediatric patients.

Both devices had high success rates for insertion on the first attempt (97.14% for I-gelTM vs. 90% for BlockbusterTM), with comparable ease of insertion and postoperative complications, suggesting that while I-gelTM is more effective, both devices are reliable options.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of oropharyngeal leak pressure of I-gelTM and BlockbusterTM laryngeal mask airway in anaesthetized pediatric patients. Selvin, CC., Singariya, G., Bihani, P., et al.[2023]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The LMA-Supreme versus the I-gel in simulated difficult airway in children: a randomised study. Kus, A., Gok, CN., Hosten, T., et al.[2022]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A comparison of supraglottic devices in pediatric patients. Krishna, SG., Syed, F., Hakim, M., et al.[2022]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A clinical evaluation of the I-gel ™ supraglottic airway device in children. Hughes, C., Place, K., Berg, S., et al.[2022]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

To assess the efficacy of i-gel for ventilation, blind tracheal intubation and nasogastric tube insertion. Bhandari, G., Shahi, KS., Asad, M., et al.[2020]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The supraglottic airway I-gel in comparison with ProSeal laryngeal mask airway and classic laryngeal mask airway in anaesthetized patients. Shin, WJ., Cheong, YS., Yang, HS., et al.[2022]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparative study of fiber-optic guided tracheal intubation through intubating laryngeal mask airway LMA Fastrach™ and i-gel in adult paralyzed patients. Sood, S., Saxena, A., Thakur, A., et al.[2022]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Comparison between the i-gel® and air-Q® Supraglottic Airway Devices Used for the Patients Undergoing General Anesthesia with Muscle Relaxation. Massoudi, N., Fathi, M., Nooraei, N., et al.[2022]

A study involving 250 combat medics revealed that the i-gel supraglottic airway device was preferred for its ease of use, comfort, and minimal training requirements, making it a strong candidate for inclusion in medic aid bags.

Qualitative feedback indicated a strong preference for both the i-gel and BaskaMask devices, suggesting that medics favor devices that are user-friendly and require less training, although prior experience with the i-gel may have influenced their preferences.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A mixed methods end-user assessment to determine the ideal supraglottic airway device for inclusion into the medic's aid bag. Schauer, SG., Tapia, AD., Hudson, IL., et al.[2022]

References

1. India pubmed.ncbi.nlm.nih.gov

Comparison of i-gel™ and laryngeal mask airway in anesthetized paralyzed patients. [2022]

2. Korea (South) pubmed.ncbi.nlm.nih.gov

Comparison of oropharyngeal leak pressure of I-gelTM and BlockbusterTM laryngeal mask airway in anaesthetized pediatric patients. [2023]

3. England pubmed.ncbi.nlm.nih.gov

The LMA-Supreme versus the I-gel in simulated difficult airway in children: a randomised study. [2022]

4. New Zealand pubmed.ncbi.nlm.nih.gov

A comparison of supraglottic devices in pediatric patients. [2022]

5. France pubmed.ncbi.nlm.nih.gov

A clinical evaluation of the I-gel ™ supraglottic airway device in children. [2022]

6. India pubmed.ncbi.nlm.nih.gov

To assess the efficacy of i-gel for ventilation, blind tracheal intubation and nasogastric tube insertion. [2020]

7. England pubmed.ncbi.nlm.nih.gov

The supraglottic airway I-gel in comparison with ProSeal laryngeal mask airway and classic laryngeal mask airway in anaesthetized patients. [2022]

8. India pubmed.ncbi.nlm.nih.gov

Comparative study of fiber-optic guided tracheal intubation through intubating laryngeal mask airway LMA Fastrach™ and i-gel in adult paralyzed patients. [2022]

9. United States pubmed.ncbi.nlm.nih.gov

A Comparison between the i-gel® and air-Q® Supraglottic Airway Devices Used for the Patients Undergoing General Anesthesia with Muscle Relaxation. [2022]

10. United States pubmed.ncbi.nlm.nih.gov

A mixed methods end-user assessment to determine the ideal supraglottic airway device for inclusion into the medic's aid bag. [2022]