Airway Management Techniques for Traumatic Injury

(PACT Trial)

Recruiting at 13 trial locations

Overseen By Jason Sperry, MD, MPH

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: Jason Sperry

Disqualifiers: Under 15, Pregnancy, Prisoner, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: Immediate intervention upon enrollment

2009 Participants Needed

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. ^{3 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. ^{1 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.

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
• 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

Supraglottic airway device is already approved in United States, European Union for the following indications:

Approved in United States as Supraglottic Airway Device for:

• Prehospital airway management in trauma patients
• Out-of-hospital cardiac arrest

Approved in European Union as Supraglottic Airway Device for:

• Prehospital airway management in trauma patients
• Out-of-hospital cardiac arrest

Who Is Running the Clinical Trial?

Jason Sperry

Lead Sponsor

Trials

9

Recruited

6,900+

United States Department of Defense

Collaborator

Trials

940

Recruited

339,000+

Findings from Research

In a study involving 50 pediatric patients, the Air-Q® laryngeal mask airway (LMA) and the i-gel® supraglottic airway (SGA) showed no significant differences in the time taken for device placement or achieving a bronchoscopic view of the glottis.

Both SGAs provided similar quality of airway visualization and sealing capabilities, indicating that either device can be effectively used in managing difficult airways in children.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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

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]

In a study involving 60 children with simulated difficult airways, the LMA-Supreme (LMA-S) demonstrated a significantly higher oropharyngeal leak pressure compared to the I-gel, indicating better airway sealing capabilities.

The LMA-S was also quicker to insert and allowed for faster gastric tube placement than the I-gel, suggesting it may be more efficient in emergency situations, although both devices were effective for ventilation.

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]

The i-gel(TM) supraglottic airway device was successfully inserted on the first attempt in 93.5% of 154 children studied, demonstrating its efficacy for airway management during anesthesia.

While the i-gel(TM) showed a high success rate for insertion and gastric tube placement, complications occurred in 20% of cases, mostly minor, indicating the need for careful monitoring during use.

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]

The i-gel supraglottic airway device demonstrated a 100% success rate for insertion, with 171 out of 180 patients successfully inserted on the first attempt, indicating its reliability as a ventilatory device.

It achieved a 78.33% success rate for blind endotracheal intubation and a 92.22% success rate for gastric tube insertion, all while maintaining acceptable airway sealing pressures with minimal complications.

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]

The I-gel supraglottic airway device demonstrated airway leak pressures comparable to the ProSeal laryngeal mask airway (pLMA) and significantly higher than the classic laryngeal mask airway (cLMA), suggesting effective airway sealing in anesthetized patients.

In a study involving 167 patients undergoing orthopedic surgery, the I-gel showed similar success rates for insertion and was not associated with adverse events, making it a promising alternative to traditional airway devices.

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]

In a study of 60 adult paralyzed patients, the i-gel supraglottic airway device demonstrated comparable ease of use and effectiveness for fiberoptic-guided tracheal intubation when compared to the LMA Fastrach™, with no significant differences in insertion time or success rates.

Both devices showed similar hemodynamic stability and ease of removal, suggesting that the i-gel could be a reliable and cost-effective alternative for airway management in clinical settings.

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]

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]

The Air-Q® supraglottic airway device was inserted significantly faster (4.87 seconds) compared to the i-gel® device (6.80 seconds), indicating a more efficient option for airway management during general anesthesia.

Patients using the i-gel® experienced a higher rate of postoperative complications, particularly sore throat (20% vs. 0% in Air-Q®), suggesting that Air-Q® may be a safer choice with fewer side effects.

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]

References

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

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

2. India pubmed.ncbi.nlm.nih.gov

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

3. 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]

4. England pubmed.ncbi.nlm.nih.gov

The LMA-Supreme versus the I-gel in simulated difficult airway in children: a randomised study. [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 mixed methods end-user assessment to determine the ideal supraglottic airway device for inclusion into the medic's aid bag. [2022]

10. 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]