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.
Studienübersicht
Status
Bedingungen
Studientyp
Einschreibung (Geschätzt)
Phase
- Unzutreffend
Kontakte und Standorte
Studienorte
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Shanghai, China, 200433
- Shanghai Pulmonary Hospital
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Kontakt:
- Juan Wei, Ph.D
- Telefonnummer: 86 13671658073
- E-Mail: sudaweijuan@163.com
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Kontakt:
- 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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Kontakt:
- Wan Yang
- Telefonnummer: 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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Kontakt:
- Dongming Xie
- Telefonnummer: 025-58006129
- E-Mail: xiedongming2026@163.com
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Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Beschreibung
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.
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Doppelt
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
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Experimental: 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. |
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Aktiver Komparator: 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. |
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Proportion of participants developing one or more major adverse events (MAEs)
Zeitfenster: The first 30 postoperative days
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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
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Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Dauer des Krankenhausaufenthalts
Zeitfenster: Vom Tag der Operation bis zum Tag der Entlassung bis zum 90. Tag
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Vom Tag der Operation bis zum Tag der Entlassung bis zum 90. Tag
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Duration of chest tube drainage
Zeitfenster: Through study completion, an average of 3 days
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Through study completion, an average of 3 days
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Reintubation
Zeitfenster: The first 30 postoperative days
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Proportion of participants requiring tracheal reintubation after initial postoperative extubation |
The first 30 postoperative days
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Hospital readmission
Zeitfenster: The first 30 postoperative days
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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
Zeitfenster: 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
Zeitfenster: The first 30 postoperative days
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Proportion of participants developing surgical site infection |
The first 30 postoperative days
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Andere Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Severe hypoxemia
Zeitfenster: During surgery
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Defined as peripheral oxygen saturation (SpO2) ≤85% for at least 10 seconds |
During surgery
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Rescue measures for hypoxemia
Zeitfenster: During surgery
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Proportion of participants receiving prespecified rescue measure for intraoperative hypoxemia (SpO2 below 90%) |
During surgery
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Mitarbeiter und Ermittler
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Geschätzt)
Primärer Abschluss (Geschätzt)
Studienabschluss (Geschätzt)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- 2025LY11105
Plan für individuelle Teilnehmerdaten (IPD)
Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?
Beschreibung des IPD-Plans
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-Sharing-Zeitrahmen
Requests will be considered beginning 6 months after publication of the main study results.
IPD-Sharing-Zugriffskriterien
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.
Art der unterstützenden IPD-Freigabeinformationen
- STUDIENPROTOKOLL
- SAFT
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
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