Postoperative ComplicationsiOXY-LUNGNCT07917897
Individualized Inspired Oxygen Fraction Titration During Lung Surgery (iOXY-LUNG)
A study testing Individualized inspired oxygen fraction titration and Continuous ventilation with 100% oxygen in people with Postoperative Complications, run by Shanghai Pulmonary Hospital, Shanghai, China at 3 sites in China.
Trial summary
The goal of this clinical trial is to determine whether individualized oxygen adjustment during lung surgery lowers the risk of major complications. The study will include adults undergoing planned surgery on one lung that requires more than one hour of one-lung ventilation. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Postoperative Complications
- What is being tested?
- Individualized inspired oxygen fraction titration and Continuous ventilation with 100% oxygen
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 628 participants
- Where
- 3 sitesChina
- Study dates
- 20 Dec 2026to 1 Mar 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Able and willing to provide written informed consent.
- Age 18 years or older.
- Scheduled for elective unilateral lung surgery requiring one-lung ventilation, with an anticipated one-lung ventilation duration of more than 1 hour.
- American Society of Anesthesiologists (ASA) physical status I-III.
Who cannot join
- Pregnancy or lactation.
- History of thoracic surgery.
- New York Heart Association class III-IV heart failure or Canadian Cardiovascular Society class III-IV coronary artery disease.
- Acute cardiovascular or cerebrovascular disease within the preceding 6 months or renal insufficiency requiring dialysis.
- Intracranial injury or tumor.
- Psychiatric illness, cognitive impairment, communication or language difficulties, or other circumstances expected to prevent follow-up or data collection.
- Participation in another interventional trial.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China3 sites
Anhui Provincial Cancer Hospital
Hefei, Anhui, 230001
Wan Yang, 0551-65327751, chinayangwan@163.com
The Second Hospital of Nanjing
Nanjing, Jiangsu, 210003
Dongming Xie, 025-58006129, xiedongming2026@163.com
Shanghai Pulmonary Hospital
Shanghai, 200433
Juan Wei, Ph.D, 86 13671658073, sudaweijuan@163.com
Xin Lv, Ph.D, xinlvg@126.com
About this study
Official title: Individualized Inspired Oxygen Titration Versus Pure Oxygen During Lung Surgery (iOXY-LUNG): a Randomized Clinical Trial
The goal of this clinical trial is to determine whether individualized oxygen adjustment during lung surgery lowers the risk of major complications. The study will include adults undergoing planned surgery on one lung that requires more than one hour of one-lung ventilation. One-lung ventilation means that only one lung is ventilated during part of the operation.
The main question is:
Read more
Does individualized oxygen adjustment, compared with continuous 100% oxygen, lower the risk of death or major complications within 30 days after surgery?
Researchers will enroll 628 participants at three hospitals in China. Participants will be randomly assigned to two groups:
- Individualized inspired oxygen titration group: The anesthesiologist will adjust the oxygen concentration according to blood oxygen saturation, measured continuously using a pulse oximeter.
- Pure oxygen group: The anesthesiologist will maintain 100% oxygen from the start of general anesthesia until removal of the tracheal tube.
Both groups will receive 100% oxygen before one-lung ventilation begins. In the individualized group, oxygen adjustment will continue after ventilation of both lungs resumes. Before removal of the tracheal tube, the anesthesiologist may raise the oxygen concentration for safety. Both groups will receive treatment if blood oxygen levels become too low.
Researchers will assess participants during hospitalization and through 30 days after surgery. Follow-up after discharge will take place by telephone or outpatient assessment. Researchers will compare deaths and major complications affecting the lungs, heart, brain, or kidneys. They will also assess recovery and safety.
- Conditions
- Postoperative Complications
- Being tested
- Individualized inspired oxygen fraction titration, Continuous ventilation with 100% oxygen
- Keywords
- Inspired oxygen fraction, lung surgery, major adverse events
- Medical subject headings
- Postoperative Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Individualized inspired oxygen fraction titrationOther
FiO2 will be 1.0 from anesthesia induction until one-lung ventilation begins. Thereafter, FiO2 will be titrated in steps of 0.05 within 0.4-1.0 to identify the lowest concentration maintaining SpO2 ≥ 92%. At SpO2 of 90%-91%, downward titration will stop and FiO2 will be increased. SpO2 below 90% will trigger the prespecified hypoxemia rescue protocol. Titration may resume once oxygenation recovers and stabilizes, as judged by the attending anesthesiologist. The same strategy will continue after two-lung ventilation resumes. Before extubation, FiO2 may be increased for oxygen reserve.
Continuous ventilation with 100% oxygenOther
FiO2 will be maintained at 1.0 from anesthesia induction until tracheal extubation, including during one-lung ventilation and after two-lung ventilation resumes.
| Study group | Role | What they receive |
|---|---|---|
| Individualized inspired oxygen fraction titration group | Experimental | Participants will receive individualized inspired oxygen titration from OLV beginning Receives: Other: Individualized inspired oxygen fraction titration |
| Pure oxygen group | Active comparator | The fraction of inspired oxygen (FiO2) will be maintained at 1.0 from anesthesia induction until tracheal extubation. Receives: Other: Continuous ventilation with 100% oxygen |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of participants developing one or more major adverse events (MAEs)
all-cause death; postoperative pulmonary complications (pneumonia; ARDS; atelectasis; respiratory failure; pulmonary embolism; pneumothorax on the nonoperated side); cardiac events (new-onset atrial fibrillation or flutter, ventricular tachycardia or ventricular fibrillation requiring treatment; myocardial infarction; heart failure); neurological complications (stroke, transient ischemic attack, delirium); acute kidney injury defined as postoperative creatinine level at least doubled from the preoperative level or kidney replacement therapy.
Measured: The first 30 postoperative days
Secondary outcomes (6)
Duration of chest tube drainage
Measured: Through study completion, an average of 3 days
Reintubation
Proportion of participants requiring tracheal reintubation after initial postoperative extubation
Measured: The first 30 postoperative days
Length of hospital stay
Measured: From the day of surgery until the day of discharge, up to day 90
Hospital readmission
Proportion of participants readmitted to a hospital after discharge from the index hospitalization and within 30 days after surgery.
Measured: The first 30 postoperative days
Sepsis
Proportion of participants developing sepsis, defined according to Sepsis-3
Measured: The first 30 postoperative days
Surgical site infection
Proportion of participants developing surgical site infection
Measured: The first 30 postoperative days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2026
- Study start20 Dec 2026 (estimated)
- Primary completion31 Jan 2028 (estimated)
- Study completion1 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative ComplicationsStudies of the same condition, open and under way.
- More trials run by Shanghai Pulmonary Hospital, Shanghai, ChinaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 628 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Pulmonary Hospital, Shanghai, China
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Juan Wei, Shanghai Pulmonary Hospital, Shanghai, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07917897
- Sponsor's protocol ID
- 2025LY11105
- Acronym
- iOXY-LUNG
- Status last verified
- Nov 2026
- First submitted
- 30 Oct 2026
- Last updated
- 5 Nov 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Deidentified individual participant data underlying the published study results will be available to qualified researchers upon reasonable request. Sharing will be subject to review of the proposed research, applicable ethical approvals, institutional requirements, and data protection requirements. Individual participant data will not be publicly accessible.
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Individualized Inspired Oxygen Titration Versus Pure Oxygen During Lung Surgery (iOXY-LUNG): a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT07917897
- Acronym / sponsor ID
- iOXY-LUNG / 2025LY11105
- Conditions
- Postoperative Complications
- Keywords
- Inspired oxygen fraction, lung surgery, major adverse events
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 628 participants (estimated)
- Lead sponsor
- Shanghai Pulmonary Hospital, Shanghai, ChinaUniversity, hospital or other
- Study start
- 20 Dec 2026 (estimated)
- Primary completion
- 31 Jan 2028 (estimated)
- Study completion
- 1 Mar 2028 (estimated)
- First posted
- 5 Nov 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this clinical trial is to determine whether individualized oxygen adjustment during lung surgery lowers the risk of major complications. The study will include adults undergoing planned surgery on one lung that requires more than one hour of one-lung ventilation. One-lung ventilation means that only one lung is ventilated during part of the operation.
The main question is:
Does individualized oxygen adjustment, compared with continuous 100% oxygen, lower the risk of death or major complications within 30 days after surgery?
Researchers will enroll 628 participants at three hospitals in China. Participants will be randomly assigned to two groups:
- Individualized inspired oxygen titration group: The anesthesiologist will adjust the oxygen concentration according to blood oxygen saturation, measured continuously using a pulse oximeter.
- Pure oxygen group: The anesthesiologist will maintain 100% oxygen from the start of general anesthesia until removal of the tracheal tube.
Both groups will receive 100% oxygen before one-lung ventilation begins. In the individualized group, oxygen adjustment will continue after ventilation of both lungs resumes. Before removal of the tracheal tube, the anesthesiologist may raise the oxygen concentration for safety. Both groups will receive treatment if blood oxygen levels become too low.
Researchers will assess participants during hospitalization and through 30 days after surgery. Follow-up after discharge will take place by telephone or outpatient assessment. Researchers will compare deaths and major complications affecting the lungs, heart, brain, or kidneys. They will also assess recovery and safety.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Individualized inspired oxygen fraction titration group | Experimental | Other: Individualized inspired oxygen fraction titrationParticipants will receive individualized inspired oxygen titration from OLV beginning |
| Pure oxygen group | Active comparator | Other: Continuous ventilation with 100% oxygenThe fraction of inspired oxygen (FiO2) will be maintained at 1.0 from anesthesia induction until tracheal extubation. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Able and willing to provide written informed consent.
- Age 18 years or older.
- Scheduled for elective unilateral lung surgery requiring one-lung ventilation, with an anticipated one-lung ventilation duration of more than 1 hour.
- American Society of Anesthesiologists (ASA) physical status I-III.
Key exclusion criteria (7 listed)
- Pregnancy or lactation.
- History of thoracic surgery.
- New York Heart Association class III-IV heart failure or Canadian Cardiovascular Society class III-IV coronary artery disease.
- Acute cardiovascular or cerebrovascular disease within the preceding 6 months or renal insufficiency requiring dialysis.
- Intracranial injury or tumor.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Individualized inspired oxygen fraction titrationFiO2 will be 1.0 from anesthesia induction until one-lung ventilation begins. Thereafter, FiO2 will be titrated in steps of 0.05 within 0.4-1.0 to identify the lowest concentration maintaining SpO2 ≥ 92%. At SpO2 of 90%-91%, downward titration will stop and FiO2 will be increased. SpO2 below 90% will trigger the prespecified hypoxemia rescue protocol. Titration may resume once oxygenation recovers and stabilizes, as judged by the attending anesthesiologist. The same strategy will continue after two-lung ventilation resumes. Before extubation, FiO2 may be increased for oxygen reserve. | Other | Individualized inspired oxygen fraction titration group |
| Continuous ventilation with 100% oxygenFiO2 will be maintained at 1.0 from anesthesia induction until tracheal extubation, including during one-lung ventilation and after two-lung ventilation resumes. | Other | Pure oxygen group |
Primary outcome
Proportion of participants developing one or more major adverse events (MAEs)
Time frame: The first 30 postoperative days
all-cause death; postoperative pulmonary complications (pneumonia; ARDS; atelectasis; respiratory failure; pulmonary embolism; pneumothorax on the nonoperated side); cardiac events (new-onset atrial fibrillation or flutter, ventricular tachycardia or ventricular fibrillation requiring treatment; myocardial infarction; heart failure); neurological complications (stroke, transient ischemic attack, delirium); acute kidney injury defined as postoperative creatinine level at least doubled from the preoperative level or kidney replacement therapy.
6 secondary outcomes
Duration of chest tube drainage
Time frame: Through study completion, an average of 3 days
Reintubation
Time frame: The first 30 postoperative days
Length of hospital stay
Time frame: From the day of surgery until the day of discharge, up to day 90
Hospital readmission
Time frame: The first 30 postoperative days
Sepsis
Time frame: The first 30 postoperative days
Surgical site infection
Time frame: The first 30 postoperative days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2026.
- Individual participant dataSharing planned: Yes. Deidentified individual participant data underlying the published study results will be available to qualified researchers upon reasonable request. Sharing will be subject to review of the proposed research, applicable ethical approvals, institutional requirements, and data protection requirements. Individual participant data will not be publicly accessible.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Individualized inspired oxygen fraction titration and Continuous ventilation with 100% oxygen in people with Postoperative Complications, run by Shanghai Pulmonary Hospital, Shanghai, China at 3 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 5 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of participants developing one or more major adverse events (MAEs) (time frame: The first 30 postoperative days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Nov 2026.