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New oxygen device could make throat surgery safer

NCT ID NCT03472118

Symptom relief Sponsor: CMC Ambroise Paré 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
The trial has finished. Results may not be published yet.
Stopped early This study
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This status has not been confirmed recently, so it may be out of date.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 tested a device that delivers high-flow oxygen through the nose during throat surgery. The goal was to keep patients' oxygen levels safe without using a breathing tube. The trial included 29 adults in two French hospitals. The device was considered safe if blood oxygen stayed above 95% and no serious complications occurred.

What this could mean

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

Active substance
Nasal High Flow Oxygen (Optiflow device)
What this could lead to
If successful, this device could offer a safer way to deliver oxygen during throat surgeries, avoiding the need for a breathing tube.
What could go wrong
The trial was terminated early with only 29 participants, so results are limited. The technique may fail if oxygen levels drop, and there is a risk of carbon dioxide buildup.

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

29 people

The number who actually took part.

Started

Jul 2018

Finished

Jan 2019

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

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: * Consent for participation * Affiliation to the french social security system * Patients undergoing any suspension laryngoscopy other than laser surgery and cavoscopy and expected to last less than 30 minutes Exclusion Criteria: * Pregnancy * Epilepsy * Arrhythmia * Pulmonary hypertension * Lung disease with basal SpO2\<95% * Obstructive laryngeal tumor * BMI\>30kg.m-2

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Conditions

The condition(s) this trial relates to.

Acidosis, Respiratory Apnea laryngeal disorder sleep apnea syndrome

As listed by the trial registrant

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

Anesthesia Apnea Laryngoscopy

Contacts and locations

Locations

  • Hôpital Foch

    Suresnes, Île-de-France Region, 92151, France

  • Hôpital René Huguenin - Institut Curie

    Saint-Cloud, Île-de-France Region, 92310, France

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