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New oxygen device may make endoscopy safer for High-Risk patients

NCT ID NCT07439822

Symptom relief Sponsor: Outcomes'10 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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests whether high-flow oxygen therapy can prevent low oxygen levels (hypoxemia) in patients at higher risk during sedated digestive endoscopy. The trial includes 326 adults with obesity, sleep apnea, or stable lung or heart conditions. Researchers will compare high-flow oxygen with standard low-flow nasal cannulas to see which is safer.

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 medical oxygen insufflation
What this could lead to
If it works, this could make digestive endoscopy safer for patients with obesity, sleep apnea, or lung disease by reducing dangerous drops in oxygen levels.
What could go wrong
This is a phase 4 study, so the intervention is already in use; however, it may not show a clear benefit over standard low-flow oxygen, and results may not apply to all patient groups.

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

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

About 326 people

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

Expected to start

Mar 2026

An estimate. Start dates often move.

Expected to finish

Oct 2026

An estimate. End dates often move.

Lead sponsor

A research network

The lead sponsor is a research network or cooperative group.

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: * Be ≥ 18 years old * Sign the Informed Consent * Obesity (BMI ≥ 30 kg/m²) * ASA III * Stable pulmonary disease (no hospitalization in the last 6 months) * Stable heart failure (no hospitalization in the last 6 months) * Diagnosed or suspected obstructive sleep apnea with a score ≥ 3 on the STOP-Bang scale (APPENDIX II) * History of sedation-related complications in a previous ESP. Exclusion Criteria: * ASA IV patients * Worsening heart failure at the time of the endoscopy or unstable (hospitalized \< 6 months) * Worsening respiratory disease at the time of the endoscopy or unstable (hospitalized \< 6 months) * Pregnant women * Use of home oxygen therapy * Patients with orotracheal intubation * Tracheostomized patients * Patients allergic to or unable to use propofol

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Conditions

The condition(s) this trial relates to.

heart failure Hypoxia obesity disorder obstructive sleep apnea syndrome

As listed by the trial registrant

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

Hypoxemia during surgery

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

    The full official record for this study. This one lists no contact details, but it is the first place any would appear.

    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

  • Hospital Universitario Río Hortega

    Valladolid, Valladolid, 47012, Spain

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