Effect of Different Inspired Oxygen Concentrations on Intraoperative Recruitment Outcomes in Patients Undergoing Abdominal Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 95
- 试验地点
- 1
- 主要终点
- Duration of improvement in lung compliance
研究概览
简要总结
This study intends to evaluate the effect of different inhaled oxygen concentrations on the effect of lung recruitment in patients undergoing abdominal surgery. During perioperative mechanical ventilation, higher FiO2 is usually given to prevent the occurrence of hypoxemia, but there are no conclusions about the setting of optimal FiO2 during surgery.
Dynamic pulmonary compliance enables real-time monitoring of alveolar changes and is used to assess pulmonary function in intraoperative patients. The value of compliance represents the number of air-containing alveoli; the more alveoli are trapped, the less air-containing tissue there is and the lower the compliance. Lung recruitment, as part of a lung-protective ventilation strategy, is effective in opening alveoli and improving oxygenation. This single-center, randomized controlled trial will explore the optimal inspired oxygen concentration that allows patients to benefit from lung recruitment and the duration of improvement in lung compliance after lung recruitment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •ASA physical status classification: I or II.
- •Adults aged 18 to 64 years, regardless of gender.
- •BMI between 18 kg/m² and 25 kg/m².
- •Patients undergoing elective abdominal surgery under general anesthesia.
- •Patients with estimated operating time ≥1.5h and intraoperative bleeding ≤500ml.
- •Patients who have provided written informed consent after understanding the study purpose, procedures, and potential risks.
排除标准
- •Previous thoracic surgery.
- •Chest X-ray or CT suggestive of pneumothorax or alveoli.
- •Lung disease: chronic bronchitis, asthma, moderate to severe obstructive ventilatory dysfunction.
- •Preoperative pulse oxygen saturation (SpO2) <90% on breathing air or SpO2 <95% on oxygen.
- •Contraindications to lung reanimation: high intracranial pressure, hypovolemic shock, right heart failure.
- •Severe heart disease (New York Heart Association, NYHA class III or IV.
- •Acute coronary syndrome or sustained ventricular tachyarrhythmia).
- •Participation in other interventional studies or refusal of enrollment.
研究组 & 干预措施
A: FiO2 = 30%
FiO2 of group A = 30%. If SPO2 < 94%, improve FiO2; if FiO2≥40%, eliminate the patient.
干预措施: Fraction of inspiration O2(FiO2) (Behavioral)
B: FiO2＝40%
FiO2＝40%
干预措施: Fraction of inspiration O2(FiO2) (Behavioral)
C: FiO2＝60%
FiO2＝60%
干预措施: Fraction of inspiration O2(FiO2) (Behavioral)
D: FiO2＝80%
FiO2＝80%
干预措施: Fraction of inspiration O2(FiO2) (Behavioral)
结局指标
主要结局
Duration of improvement in lung compliance
时间窗: during the surgery
Time to return to baseline levels of lung compliance after lung recruitment
次要结局
- Incidence of hypoxemia during PACU(From the time of entry to the PACU to the time of exit from the PACU)
- Incidence of pulmonary atelectasis at the end of surgery(Surgery complete, extubation immediate)
- Incidence of pulmonary complications within 3 days after surgery(From the end of surgery to 3 days after surgery)
研究者
Ju Gao
Study Director
Northern Jiangsu People's Hospital