Individualized Inspired Oxygen Fraction Titration During Lung Surgery (iOXY-LUNG) (iOXY-LUNG)
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:
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.
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Studietype
Inschrijving (Geschat)
Fase
- Niet toepasbaar
Contacten en locaties
Studie Locaties
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Shanghai, China, 200433
- Shanghai Pulmonary Hospital
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Contact:
- Juan Wei, Ph.D
- Telefoonnummer: 86 13671658073
- E-mail: sudaweijuan@163.com
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Contact:
- Xin Lv, Ph.D
- E-mail: xinlvg@126.com
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Anhui
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Hefei, Anhui, China, 230001
- Anhui Provincial Cancer Hospital
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Contact:
- Wan Yang
- Telefoonnummer: 0551-65327751
- E-mail: chinayangwan@163.com
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Jiangsu
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Nanjing, Jiangsu, China, 210003
- The Second Hospital of Nanjing
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Contact:
- Dongming Xie
- Telefoonnummer: 025-58006129
- E-mail: xiedongming2026@163.com
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Dubbele
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
|
Experimenteel: Individualized inspired oxygen fraction titration group
Participants will receive individualized inspired oxygen titration from OLV beginning |
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. |
|
Actieve vergelijker: Pure oxygen group
The fraction of inspired oxygen (FiO2) will be maintained at 1.0 from anesthesia induction until tracheal extubation. |
FiO2 will be maintained at 1.0 from anesthesia induction until tracheal extubation, including during one-lung ventilation and after two-lung ventilation resumes. |
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Proportion of participants developing one or more major adverse events (MAEs)
Tijdsspanne: 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. |
The first 30 postoperative days
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Duur van het ziekenhuisverblijf
Tijdsspanne: Vanaf de dag van de operatie tot de dag van ontslag, tot en met dag 90
|
Vanaf de dag van de operatie tot de dag van ontslag, tot en met dag 90
|
|
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Duration of chest tube drainage
Tijdsspanne: Through study completion, an average of 3 days
|
Through study completion, an average of 3 days
|
|
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Reintubation
Tijdsspanne: The first 30 postoperative days
|
Proportion of participants requiring tracheal reintubation after initial postoperative extubation |
The first 30 postoperative days
|
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Hospital readmission
Tijdsspanne: The first 30 postoperative days
|
Proportion of participants readmitted to a hospital after discharge from the index hospitalization and within 30 days after surgery. |
The first 30 postoperative days
|
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Sepsis
Tijdsspanne: The first 30 postoperative days
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Proportion of participants developing sepsis, defined according to Sepsis-3 |
The first 30 postoperative days
|
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Surgical site infection
Tijdsspanne: The first 30 postoperative days
|
Proportion of participants developing surgical site infection |
The first 30 postoperative days
|
Andere uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Severe hypoxemia
Tijdsspanne: During surgery
|
Defined as peripheral oxygen saturation (SpO2) ≤85% for at least 10 seconds |
During surgery
|
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Rescue measures for hypoxemia
Tijdsspanne: During surgery
|
Proportion of participants receiving prespecified rescue measure for intraoperative hypoxemia (SpO2 below 90%) |
During surgery
|
Medewerkers en onderzoekers
Studie record data
Bestudeer belangrijke data
Studie start (Geschat)
Primaire voltooiing (Geschat)
Studie voltooiing (Geschat)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- 2025LY11105
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
Beschrijving IPD-plan
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.
IPD-tijdsbestek voor delen
Requests will be considered beginning 6 months after publication of the main study results.
IPD-toegangscriteria voor delen
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.
IPD delen Ondersteunend informatietype
- LEERPROTOCOOL
- SAP
Informatie over medicijnen en apparaten, studiedocumenten
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