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Less oxygen during surgery may protect lungs in elderly patients

NCT ID NCT06359106

Disease control Sponsor: China Medical University, China 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study compares giving 40% versus 80% oxygen during laparoscopic gastrointestinal surgery in patients aged 65 and older. The goal is to see which oxygen level leads to better lung function after surgery. Over 1,100 participants will be randomly assigned to one of the two oxygen levels, and their oxygen levels and lung complications will be tracked for 7 days.

What this could mean

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

Active substance
inhaled oxygen (40% or 80% concentration)
What this could lead to
If it works, this could show that using less oxygen during surgery is safer for older patients' lungs, leading to better recovery guidelines.
What could go wrong
This is a phase 4 trial comparing two standard oxygen levels, so it's not testing a new treatment. The results may only apply to older patients having specific laparoscopic surgery, and the difference between groups might be small.

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 1,176 people

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

Started

Jul 2024

Expected to finish

Jun 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

65 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: * Age not less than 65 years * American Society of Anesthesiologists grades I-III * No history of drug allergies or abnormal anesthesia. * The duration of mechanical ventilation was expected to be more than 2 hours. * Laparoscopic Gastrointestinal Surgery * The preoperative oxygen saturation was not less than 94%. * The patients will be planned to extubate in the operating room. Exclusion Criteria: * History of acute lung injury or acute respiratory distress syndrome (ARDS) within 3 months. * Cardiac function Class IV (New York Heart Association classification) * Chronic renal failure (renal cell filtration rate \<30 ml min-11.73/m2), severe liver disease * Patients with blurred consciousness and cognitive dysfunction * Severe coagulation dysfunction. * Without preoperative oxygen inhalation, blood oxygen level \<94%, and severe pulmonary dysfunction * Patients with endotracheal tubes were admitted to the intensive care unit (ICU) after surgery. * Body mass index (BMI) \>30kg/m2 * Inability to complete the study

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As listed by the trial registrant

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

Oxygenation index

How to take part

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

  1. The places running it

    16 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

  • Affiliated Hospital of Qingdao University

    RECRUITING

    Qingdao, China

  • Beijing Friendship Hospital, Capital Medical University

    RECRUITING

    Beijing, China

  • Chifeng Municipal Hospital

    RECRUITING

    Chifeng, China

  • Dalian Third People's Hospital

    RECRUITING

    Dalian, China

  • First Affiliated Hospital of Harbin Medical University

    RECRUITING

    Harbin, China

  • First Affiliated Hospital of Kunming Medical University

    RECRUITING

    Kunming, China

  • First Affiliated Hospital, Dalian Medical University

    RECRUITING

    Dalian, China

  • First Hospital of Hebei Medical University

    RECRUITING

    Shijia Zhuang, China

  • First Medical University and Shandong Provincial Qianfoshan Hospital

    RECRUITING

    Jinan, China

  • Harbin Medical University Cancer Hospital

    RECRUITING

    Harbin, China

  • Liaoning Cancer Hospital and Institute

    RECRUITING

    Shenyang, China

  • Second Hospital of Hebei Medical University

    RECRUITING

    Shijia Zhuang, China

  • Shenzhen People's Hospita

    RECRUITING

    Shenzhen, China

  • Sichuan Provincial People's Hospital

    RECRUITING

    Chendu, China

  • YANBIAN University Hospital（Yanbian Hospital）

    RECRUITING

    Yanbian, China

  • the First Hospital of China Medical University

    RECRUITING

    Shenyang, Liaoning, 110001, China

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