Prospective Observational Evaluation of the Association Between Perioperative Changes in Diaphragmatic Excursion and Postoperative Oxygenation and Hypoxemia in Patients Undergoing Laparoscopic Cholecystectomy
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 62
- 试验地点
- 1
- 主要终点
- diaphragmatic excursion (ΔDE) and postoperative hypoxemia
研究概览
简要总结
Laparoscopic cholecystectomy and the associated pneumoperitoneum can impair diaphragmatic mechanics and reduce postoperative oxygenation. This prospective observational study aims to evaluate perioperative changes in diaphragmatic excursion measured by ultrasonography and to investigate their association with early postoperative oxygenation parameters and hypoxemia. By correlating diaphragmatic excursion changes with SpO₂/FiO₂ and the ROX index, the study seeks to clarify the physiological contribution of diaphragmatic dysfunction to postoperative hypoxemia in patients undergoing laparoscopic cholecystectomy.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults aged 18-75 years
- •Scheduled for elective laparoscopic cholecystectomy under general anesthesia
- •Able to undergo diaphragm ultrasonography (no preoperative barrier to assessment)
- •Able to cooperate with preoperative and early postoperative diaphragm measurements
- •Postoperative oxygenation data available (SpO₂, FiO₂, and SpO₂/FiO₂ can be recorded)
- •Provided written informed consent
排除标准
- •Morbid obesity (BMI ≥ 40 kg/m²)
- •Known diaphragmatic paralysis, phrenic nerve injury, or hemidiaphragm dysfunction
- •Severe COPD, restrictive lung disease, or advanced parenchymal lung disease
- •Preoperative home oxygen therapy or CPAP/BiPAP/home mechanical ventilation
- •Conversion to open surgery (laparoscopic → open)
- •Hemodynamic instability preoperatively or intraoperatively; emergency/complicated surgery
- •Factors preventing ultrasound assessment (e.g., marked upper abdominal gas, large scar/wound, severe subcutaneous edema)
- •Same-day discharge cases with <24-hour observation
- •Inability to complete measurements (e.g., severe cognitive impairment, poor cooperation, severe pain preventing measurement)
- •Incomplete data not compatible with the protocol
结局指标
主要结局
diaphragmatic excursion (ΔDE) and postoperative hypoxemia
时间窗: Preoperative baseline and 15 minutes after admission to the post-anesthesia care unit (PACU).
Association between perioperative change in diaphragmatic excursion (ΔDE) and postoperative hypoxemia, defined as SpO₂ \< 92% and/or a clinically significant decrease in the SpO₂/FiO₂ ratio.
次要结局
未报告次要终点
研究者
İlke Dolgun
Assoc. prof
Haseki Training and Research Hospital