An interventional study of Individualized inspired oxygen fraction titration and Continuous ventilation with 100% oxygen in Postoperative Complications, sponsored by Shanghai Pulmonary Hospital, Shanghai, China. Not yet recruiting at 3 sites in China. Open to participants aged 18 Years to 100 Years. Per ClinicalTrials.gov, last updated 2026-11-05.
Sponsored by Shanghai Pulmonary Hospital, Shanghai, China · Not applicable, Interventional, and Treatment
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:
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.
1,278 studies on the registry are indexed under Postoperative Complications; 302 are open to participants now.
This study's planned enrollment of 628 is above the median of 118 across 717 interventional studies indexed under Postoperative Complications.
Browse Postoperative Complications studies →Shanghai Pulmonary Hospital, Shanghai, China is the lead sponsor of 159 studies on the registry; 95 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Participants will receive individualized inspired oxygen titration from OLV beginning
Other: Individualized inspired oxygen fraction titration
The fraction of inspired oxygen (FiO2) will be maintained at 1.0 from anesthesia induction until tracheal extubation.
Other: Continuous ventilation with 100% oxygen
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.
FiO2 will be maintained at 1.0 from anesthesia induction until tracheal extubation, including during one-lung ventilation and after two-lung ventilation resumes.
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.
Time frame: The first 30 postoperative days
Duration of chest tube drainage
Time frame: Through study completion, an average of 3 days
Reintubation
Proportion of participants requiring tracheal reintubation after initial postoperative extubation
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
Proportion of participants readmitted to a hospital after discharge from the index hospitalization and within 30 days after surgery.
Time frame: The first 30 postoperative days
Sepsis
Proportion of participants developing sepsis, defined according to Sepsis-3
Time frame: The first 30 postoperative days
Surgical site infection
Proportion of participants developing surgical site infection
Time frame: The first 30 postoperative days
Severe hypoxemia
Defined as peripheral oxygen saturation (SpO2) ≤85% for at least 10 seconds
Time frame: During surgery
Rescue measures for hypoxemia
Proportion of participants receiving prespecified rescue measure for intraoperative hypoxemia (SpO2 below 90%)
Time frame: During surgery
Plan to share: 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.
Supporting information: Study protocol, Statistical analysis plan
Time frame: Requests will be considered beginning 6 months after publication of the main study results.
Access criteria: Researchers should submit a methodologically sound research proposal and analysis plan to the corresponding author. Requests will be reviewed by the study leadership team. Access to the minimum necessary deidentified data and supporting documents will require approval of the proposal, any necessary ethical and institutional approvals, and a signed data use agreement.
No publications or documents are linked to this record.
Start is estimated for Dec 2026; primary completion for Jan 2028, 13 months later.
Of 380 non-industry interventional studies with no phase under Postoperative Complications, half reached primary completion within 21 months of starting (the median), counting those still running; a quarter within 8 and three quarters within 42. This study's planned 13 months is below that.
Counting every sponsor, half of 384 studies reached it within 22 months; a quarter within 9 and three quarters within 42.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Nov 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Shanghai Pulmonary Hospital, Shanghai, China →