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临床试验/NCT06517550
NCT06517550已完成不适用

Effect of Protective Lung Ventilation Measures on Pulmonary Complications in Elderly Patients After Upper Abdominal Laparoscopy

China-Japan Friendship Hospital1 个研究点 分布在 1 个国家目标入组 136 人开始时间: 2024年10月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
136
试验地点
1
主要终点
the changes of oxygenation index

研究概览

简要总结

The incidence of postoperative pulmonary complications in elderly patients undergoing upper abdominal laparoscopic surgery remains high, and the lung protective mechanical ventilation strategy aims to reduce the incidence of lung injury caused by ventilators. PEEP, as an important protective ventilation strategy, maintains end expiratory alveolar volume to improve intraoperative oxygenation and pulmonary respiratory mechanics, and plays a protective role in the lungs; Personalized PEEP is the most beneficial, especially for elderly patients. However, there is currently no ideal way to achieve precise and personalized regulation of PEEP. This project aims to target and control intraoperative mechanical ventilation to drive pressure, personalize PEEP titration, and conduct a randomized controlled study on perioperative changes in pulmonary oxygenation function and pulmonary complications in elderly patients undergoing upper abdominal laparoscopy.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Single Group
主要目的
Prevention
盲法
Double (Participant, Care Provider)

入排标准

年龄范围
60 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • ASA<III、 general anesthesia, 60-80 years, BMI<30kg/m2, pneumoperitoneum time>0.5h, laparoscopic surgery on the upper abdomen (stomach, liver, gallbladder)

排除标准

  • Severe anemia (Hb<60g/L), OSA, severe COPD (FEV1<30% pre), asthma, bronchiectasis, preoperative pulmonary infection, respiratory failure, thoracic deformity, postoperative return to ICU, heart function grade III-IV, severe liver and kidney dysfunction (Child B or C, dialysis), intraoperative bleeding greater than 30% of blood volume.

研究组 & 干预措施

PEEP 5 cmH2O

No Intervention

During the surgical mechanical ventilation process, a constant PEEP value of 5 cmH2O is set.

Personalized PEEP

Experimental

During surgical mechanical ventilation, individualized PEEP values are set based on each patient's lung condition.

干预措施: positive end-expiratory pressure while mechanical ventilation (Other)

结局指标

主要结局

the changes of oxygenation index

时间窗: pre-surgery, leave-PACU, one-day after surgery and 7-day after surgery

The patients' changes of Oxygenation index when leave-PACU, one-day after surgery and 7-day after surgery compared with pre-sugery oxygenation index

次要结局

  • Incidence of pulmonary complications(30 and 90 days after surgery)

研究者

发起方
China-Japan Friendship Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Jinjing Zhang

Principal Investigator

China-Japan Friendship Hospital

研究点 (1)

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