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New video mask may make Kids' anesthesia safer and easier

NCT ID NCT07266389

Symptom relief Sponsor: National University of Malaysia 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 This study
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 Results may not be published yet.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
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This status has not been confirmed recently, so it may be out of date.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 tests a new device called SafeLM™, a video-equipped breathing mask for children during surgery. Researchers want to see how easy it is to place, how well it seals the airway, and if it causes any problems. About 60 children aged up to 18 who need general anesthesia will take part.

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

About 60 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Dec 2025

An estimate. Start dates often move.

Expected to finish

May 2026

An estimate. End dates often move.

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

0 to 18 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

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 * Patients who are scheduled for a surgery under general anaesthesia where supraglottic airway is deemed appropriate. * ASA I or II * Age up to 18 years old * Body weight of 10 kg and above Exclusion criteria * Presence of risk of gastric regurgitation or aspiration * Recent upper respiratory tract infection within 2 weeks * Uncontrolled respiratory co-morbidity such as bronchial asthma, chronic lung disease, restrictive lung disease * Presence of congenital airway abnormalities * Patient or next of kins refusal in participating this study

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As listed by the trial registrant

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

Anesthesia Paediatric airway management Supraglottic airway efficiency

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    2 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Universiti Kebangsaan Malaysia

    Cheras, Kuala Lumpur, 56000, Malaysia

  • University of Malaya

    Kuala Lumpur, 50603, Malaysia

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