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.
연구 개요
상태
정황
연구 유형
등록 (추정된)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Shanghai, 중국, 200433
- Shanghai Pulmonary Hospital
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연락하다:
- Juan Wei, Ph.D
- 전화번호: 86 13671658073
- 이메일: sudaweijuan@163.com
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연락하다:
- Xin Lv, Ph.D
- 이메일: xinlvg@126.com
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Anhui
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Hefei, Anhui, 중국, 230001
- Anhui Provincial Cancer Hospital
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연락하다:
- Wan Yang
- 전화번호: 0551-65327751
- 이메일: chinayangwan@163.com
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Jiangsu
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Nanjing, Jiangsu, 중국, 210003
- The Second Hospital of Nanjing
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연락하다:
- Dongming Xie
- 전화번호: 025-58006129
- 이메일: xiedongming2026@163.com
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
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.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 더블
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
실험적: 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. |
|
활성 비교기: 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. |
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Proportion of participants developing one or more major adverse events (MAEs)
기간: 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
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
입원 기간
기간: 수술 당일부터 퇴원일까지 90일까지
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수술 당일부터 퇴원일까지 90일까지
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Duration of chest tube drainage
기간: Through study completion, an average of 3 days
|
Through study completion, an average of 3 days
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Reintubation
기간: 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
기간: 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
기간: 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
기간: 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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기타 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Severe hypoxemia
기간: 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
기간: 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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공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
- 2025LY11105
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
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 공유 기간
Requests will be considered beginning 6 months after publication of the main study results.
IPD 공유 액세스 기준
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 공유 지원 정보 유형
- 연구_프로토콜
- 수액
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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