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I-gel mask vs. standard tube: which is safer for short surgeries?

NCT ID NCT05782517

Knowledge-focused Sponsor: Universitair Ziekenhuis Brussel 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study compared two ways to help patients breathe during short gynecologic laparoscopic procedures: the I-gel laryngeal mask (a soft tube placed in the throat) and the standard endotracheal tube (a tube placed into the windpipe). Researchers measured air leaks, ease of placement, and side effects in 120 participants. The goal was to see if the I-gel mask is a safe and simpler alternative for surgeries lasting under two hours.

What this could mean

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

Active substance
I-gel laryngeal mask (supraglottic airway device) and endotracheal tube
What this could lead to
If successful, this could show that the I-gel mask is a safer, easier alternative to standard intubation for short laparoscopic surgeries.
What could go wrong
This is a small, completed study with 120 participants, so results may not apply to all patients or longer procedures. The comparison is about device performance, not a new treatment.

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

120 people

The number who actually took part.

Started

Oct 2023

Finished

Oct 2024

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

18 years and older

Sex

Female participants only

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: * The expected duration of the procedure does not exceed 2 hours * Agreeing to participate in the study Exclusion Criteria: * The expected duration of the procedure is longer than 2 hours * The patient suffers from restricted mouth opening, trismus, recent oral trauma or oral abscesses * The patient has a BMI of more than 40 kg/m² * The patient is known to have gastroparesis or another risk factor that would prevent you from being sober during the procedure

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As listed by the trial registrant

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

Intubation complication Laryngeal mask complication

Contacts and locations

Locations

  • UZ Brussel

    Jette, Brussels Capital, 1090, Belgium

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