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Which airway device wins? 700-Patient trial pits LMA ProSeal against I-Gel

NCT ID NCT00624403

Knowledge-focused Sponsor: University Hospital, Bordeaux 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 completed trial compared two devices used to help patients breathe during surgery: the LMA ProSeal and the I-Gel. Researchers enrolled 700 adults and measured how easily each device was inserted, how well it sealed the airway, and any side effects. The goal was to see if one device works better or causes fewer problems.

What this could mean

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

Active substance
Laryngeal mask airway device
What this could lead to
If one device proves better, it could guide which tool doctors choose for safer airway management during surgery.
What could go wrong
This is a completed device comparison, not a treatment trial. Results may not apply to all patients or settings.

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

700 people

The number who actually took part.

Start date

Mar 2008

Finished

Dec 2013

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

Children (under 18), adults (18 to 64) and older adults (65 and over)

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: * Weight \> 30 kg * Surgery allowing the use of laryngeal mask as airway management * Written informed consent Exclusion Criteria: * Difficult intubation criteria (defined by French Anesthesia-Reanimation Society) * Pulmonary disease * Gastroesophageal reflux antecedent * Coeliosurgery * Inhalation risk * Hiatus hernia

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As listed by the trial registrant

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

Endotracheal intubation

Contacts and locations

Locations

  • Uniersity Hospital, Bordeaux

    Bordeaux, 33000, France

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