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No mask needed? new device may simplify anesthesia start

NCT ID NCT03554863

Symptom relief Sponsor: CMC Ambroise Paré Source: ClinicalTrials.gov ↗

What the study statuses mean

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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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 2 times

Summary

This study tested whether a device called Optiflow, which delivers warm, humidified oxygen through the nose, could replace the usual face mask during the start of anesthesia. The goal was to see if it could safely oxygenate patients without needing to hold a mask on their face. Sixty adults undergoing general anesthesia with oral intubation took part, and researchers filmed the process to check if mask ventilation was still required.

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 could make anesthesia induction easier and more comfortable by avoiding the need for a face mask.
What could go wrong
This is a small, completed study with only 60 participants, so results may not apply to all patients. The technique may not work for those with breathing difficulties.

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

60 people

The number who actually took part.

Started

Nov 2018

Finished

Feb 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 to 90 years

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 benefit general anesthesia with oral intubation Exclusion Criteria: * Pregnant or breastfeeding patients; * Patients with difficulty of ventilation by Optiflow AnesthesiaTM (facial trauma); * Patients under the protection of justice * Patients with drained or undrained pneumothorax; * Patients with a predicted difficulty of mask ventilation or intubation according to the clinical examination prior to inclusion (arne score ≥ 11) or when treating the patient in the operating room; * Patients with coronary heart disease, heart failure or respiratory failure; * Patients with intracranial pathology; patients with arterial oxygen saturation \<95% in the open air; * Patients for whom the surgical procedure requires the installation of a double-lumen tube; * Patients requiring rapid sequence induction; patients for whom the induction can not be carried out by the sequence sufentanil, propofol, rocuronium; * Patients with sugammadex allergy; * Patients placed under judicial protection * Patients who have already been included in the study

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As listed by the trial registrant

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

Anesthesia

Contacts and locations

Locations

  • CMC Ambroise Paré

    Neuilly-sur-Seine, Île-de-France Region, 92200, France

  • Hôpital Foch

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

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