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Simple Pre-Surgery breathing test may spot oxygen risk after Weight-Loss surgery

NCT ID NCT07303205

Knowledge-focused Sponsor: Istinye University 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 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study will check if a simple breathing measurement called the ROX index, taken before bariatric surgery, can predict which patients will have low oxygen levels in the first 12 hours after surgery. Researchers will measure the ROX index along with other risk scores in 80 adults having weight-loss surgery. No treatment is given—the study only observes and analyzes existing care.

What this could mean

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

What this could lead to
If successful, this could help doctors identify patients at risk of low oxygen after bariatric surgery, allowing earlier monitoring or preventive care.
What could go wrong
This is a small observational study (80 people) that only looks at prediction, not treatment. The ROX index may not be accurate enough to change practice.

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.

Participants

About 80 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

Mar 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.

Who is studied

The study population consists of adult patients scheduled for elective bariatric surgery, including laparoscopic sleeve gastrectomy and Roux-en-Y gastric bypass. All participants are obese (BMI ≥ 35 kg/m²) and evaluated preoperatively in the anesthesia clinic prior to surgery.

Ages

18 to 65 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: * Adults aged 18-65 years * Scheduled for elective bariatric surgery (laparoscopic sleeve gastrectomy or Roux-en-Y gastric bypass) * Body mass index (BMI) ≥ 35 kg/m² * ASA physical status I-III * Able and willing to provide written informed consent Exclusion Criteria: * Acute respiratory failure, pneumonia, or active pulmonary infection * Receiving oxygen therapy or respiratory support (nasal cannula, CPAP, BiPAP, or high-flow oxygen) preoperatively * Preoperative SpO₂ \< 88% on room air * Significant cardiac arrhythmia, severe heart failure (NYHA class III-IV), or hemodynamic instability * Pregnancy, active malignancy, or current immunosuppressive therapy * Inability to complete postoperative follow-up or early discharge before 12-hour assessment

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Conditions

The condition(s) this trial relates to.

Hypoxia obesity disorder

As listed by the trial registrant

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

Hypoxemia

How to take part

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  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

  • Istinye Üniversity

    Istanbul, Merkez Mahallesi, 34250, Turkey (Türkiye)

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