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Can a special oxygen mask save frail surgery patients from lung trouble?

NCT ID NCT07464730

Disease control Sponsor: Region Stockholm Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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 Results may not be published yet.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
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This status has not been confirmed recently, so it may be out of date.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 is testing whether giving high-flow nasal oxygen right after major surgery can reduce lung complications in frail adults. About 200 high-risk patients having abdominal or chest surgery will be randomly assigned to receive either high-flow oxygen or standard oxygen. The goal is to see if the high-flow approach lowers the chance of serious lung issues in the first week after surgery.

What this could mean

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

Active substance
High-flow nasal oxygen
What this could lead to
If it works, this could provide a simple way to prevent serious lung problems after major surgery in frail patients.
What could go wrong
This is a relatively small, early-stage trial, and results from similar studies have been mixed. It may not show a clear benefit.

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 200 people

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

Started

Apr 2026

Expected to finish

Mar 2029

An estimate. End dates often move.

Lead sponsor

A government agency

The lead sponsor is a government body.

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: Adults (≥18 years old) scheduled for elective abdominal (laparotomy or laparoscopy), open abdominal vascular or non-cardiac thoracic surgery under general anaesthesia with an estimated duration over 3 hours. AND Meeting at least two of the following criteria: * Age \> 65 years * BMI \>30 * Preoperative SpO2 \<95 % * Scheduled for lobectomy or pulmonary segment resection * Respiratory tract infection the last month * Preoperative anaemia (Hb \<100) or severe hypoalbuminemia (\<20 g/L) * Current smoker or previous smoker with \>30 packyears * Pulmonary disease or OSAS * Heart failure * Clinical frailty (CFS 4) Exclusion Criteria: * Not suitable for postoperative HFNO, as decided by a study member or the anaesthetist in charge (such as total nasal obstruction, skull fracture, facial injuries) * Pregnancy * Not able to understand the study information or sign an informed consent. * Not able to participate with the treatment postoperatively * Planned for delayed extubation in the intensive care * Preoperative non-invasive ventilation due to respiratory failure or a higher level of care than a regular ward

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As listed by the trial registrant

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

Postoperative pulmonary complications (PPCS)

How to take part

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

  1. The places running it

    1 site. 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

  • Karolinska University Hospital

    RECRUITING

    Stockholm, Sweden

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