Airway Management Techniques for Traumatic Injury

(PACT Trial)

Recruiting at 12 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores the best ways to manage airways in individuals with traumatic injuries who need advanced breathing assistance before reaching the hospital. It compares the usual approach with a new method using a supraglottic airway device, a type of breathing tube. The trial aims to determine which method improves survival in the first 24 hours and beyond. This trial suits individuals who have suffered a traumatic injury, are being transported to a participating trauma center, and require advanced airway management due to breathing difficulties. As an unphased trial, it offers participants the chance to contribute to important research that could enhance emergency care for future patients.

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 prior data suggests that these airway management techniques are safe for trauma patients?

Research has shown that supraglottic airway devices are generally safe for emergency use. One study on the i-gel supraglottic airway device found fewer airway-related safety issues after it became widely used, indicating its acceptance and potential safety advantage over other methods.

Another study found that these devices are easy to place correctly, ensuring effective performance when used properly. This reduces complications during emergencies. Overall, evidence supports supraglottic airway devices as a safe option for assisting trauma patients with breathing. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the supraglottic airway method for managing traumatic injuries because it offers a potentially faster and less invasive way to secure an airway compared to traditional intubation. Unlike the standard of care, which often involves inserting a tube directly into the trachea, the supraglottic device sits above the vocal cords, reducing the risk of injury and complications. This method could streamline the process, especially in emergency situations, improving patient outcomes when time is critical.

What evidence suggests that these airway management techniques are effective for traumatic injury?

Research has shown that devices like the iGel, which keep airways open, can improve survival rates for those needing emergency breathing support outside hospitals. In this trial, participants will be assigned to either the Supraglottic airway method arm, using devices like the iGel, or the Standard airway method arm. Studies have found that supraglottic airway devices lead to better outcomes than traditional methods like the King Laryngeal Tube, especially during emergencies such as cardiac arrest outside hospitals. For patients with injuries, evidence suggests that proper airway management can significantly impact recovery and survival chances. While most research focuses on non-injury cases, the benefits of these devices may also extend to injuries, indicating their potential usefulness in such situations. ^{1 2 6 7 8}

Who Is on the Research Team?

Jason Sperry, MD, MPH

Principal Investigator

University of Pittsburgh

Francis Guyette, MD, MPH

Principal Investigator

University of Pittsburgh

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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-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]

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 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]

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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10992989/

The i‐gel® supraglottic airway device compared to ... This pre/post study compared airway placement metrics in prehospital patients requiring advance airway management for non‐trauma‐related conditions.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11846024/

A retrospective comparison of the King Laryngeal Tube ... These data suggest that use of the iGel supraglottic airway for OHCA resuscitation in comparison to use of the King-LT is associated with improved survival with ...

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1067991X18302724

Prehospital Airway Management in Severe Traumatic Brain ... The aim of this review was to evaluate the latest evidence regarding the impact of prehospital airway management and the outcome after traumatic brain injury.

4. tsaco.bmj.com tsaco.bmj.com/content/5/1/e000539

airway management in adult trauma patients This WTA algorithm will review with most recent evidence and provide recommendations for airway management for the adult trauma patient.

5. tandfonline.com tandfonline.com/doi/full/10.1080/10903127.2023.2169422

A Retrospective Nationwide Comparison of the iGel and ... In this study, we aimed to compare outcomes of OHCA patients who had airway management by emergency medical services (EMS) with the iGel or King-LT.

6. journals.lww.com journals.lww.com/anesthesia-analgesia/fulltext/2025/02000/real_world_evaluation_of_i_gel_introduction_on.5.aspx

Real-World Evaluation of i-gel Introduction on... We found a significant decline in the monthly trend of airway-related safety events after the full implementation of i-gel in our health care network.

7. c-tecc.org c-tecc.org/images/Supraglottic_Airway_Devices_in_Tactical_Emergency_Casualty_Care_FINAL.pdf

Supraglottic Airway Devices in Tactical Emergency ... In the civilian pre-hospital environment, advanced airway interventions occur in 0.6% of calls, with an overall success rate of 89.1% [2]. Data ...

8. mdpi.com mdpi.com/2227-9032/13/12/1404

An Evaluation of Four Supraglottic Airway Devices by ... According to the latest data provided by the World Health Organization (WHO), RTAs are the leading cause of death in those aged between 5 and 29 years [6].