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New study tests best emergency breathing tube for trauma victims

NCT ID NCT04100564

Disease control Sponsor: Jason Sperry Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study looked at over 2,000 trauma patients who needed help breathing before arriving at the hospital. Half were given a supraglottic airway device (like an LMA or King tube) first, while the other half received standard care. The goal was to see which approach led to more patients surviving the first 24 hours. The trial took place across 17 ambulance services and trauma centers.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Supraglottic airway device (e.g., LMA, King, i-gel)
What this could lead to
If successful, this could establish a better standard for emergency airway management in trauma, potentially saving more lives within the first 24 hours.
What could go wrong
This is a completed trial, but results may not apply to all trauma settings or patient types. The intervention is a device, not a drug, so benefits may be modest and depend on paramedic training.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

2,010 people

The number who actually took part.

Started

Apr 2021

Finished

Apr 2026

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

15 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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 exclusion criteria will be assessed based on information available at the time of enrollment, defined as the time at which enrolling agency provides positive pressure ventilation support. Although all reasonable efforts will be made by the emergency medical crew to either directly witness or obtain documentation of inclusion criteria, due to the nature of the emergency prehospital setting, there may be occasions where the emergency medical crew must rely on verbal report of inclusion criteria from referring hospital or emergency crew. In these instances, if, after subsequent review of outside hospital and/or ground crew documentation, it is determined that the subject did not meet inclusion criteria and/or met exclusion criteria, the subject will remain enrolled in the study based on the intention-to-treat principle. If a verbal report must be used in lieu of physical documentation or directly witnessing inclusion criteria, documentation of the verbal report will serve as the source documentation for determining eligibility. Verbal reports will be documented in the emergency medical record and will detail the information provided and by whom.

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Conditions

The condition(s) this trial relates to.

Accidental Injuries injury

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Airway control Trauma injury

Contacts and locations

Locations

  • Allegheny General Hospital

    Pittsburgh, Pennsylvania, 15212, United States

  • East Carolina University

    Greenville, North Carolina, 27835, United States

  • Emory University

    Atlanta, Georgia, 30303, United States

  • John H. Stroger Hospital of Cook County

    Chicago, Illinois, 60612, United States

  • Mount Sinai Hospital

    Chicago, Illinois, 60608, United States

  • Northwestern Memorial Hospital

    Chicago, Illinois, 60611, United States

  • Oregon Health & Science University

    Portland, Oregon, 97239, United States

  • Tulane University

    New Orleans, Louisiana, 70112, United States

  • UPMC

    Pittsburgh, Pennsylvania, 15261, United States

  • University of Chicago

    Chicago, Illinois, 60637, United States

  • University of Louisville

    Louisville, Kentucky, 40208, United States

  • University of Pittsburgh

    Pittsburgh, Pennsylvania, 15213, United States

  • Vanderbilt University

    Nashville, Tennessee, 37235, United States

  • Washington University at St. Louis

    St Louis, Missouri, 63110, United States

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