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临床试验/NCT07161466
NCT07161466已完成不适用

Effects of Positive End-Expiratory Pressure Levels on Lung Recruitment Duration and Hemodynamics After Alveolar Recruitment Maneuver: A Randomized Clinical Trial

Northern Jiangsu People's Hospital1 个研究点 分布在 1 个国家目标入组 101 人开始时间: 2025年8月30日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
101
试验地点
1
主要终点
the duration of improvement in lung compliance

研究概览

简要总结

During general anesthesia surgery, the role of positive end-expiratory pressure (PEEP) in mechanical ventilation remains uncertain. Pressure levels above 0 cm H₂O can prevent postoperative pulmonary complications but may also cause intraoperative circulatory depression and lung injury due to overdistension. Using very low levels of PEEP may lead to atelectasis. However, high levels of PEEP can not only trigger complications such as intraoperative circulatory depression but also promote hyperinflation. Positive end-expiratory pressure (PEEP) is required to prevent atelectasis during lung-protective ventilation, and different levels of PEEP exhibit varying physiological and clinical effects when used alone or in combination with alveolar recruitment maneuvers (ARM). Alveolar recruitment maneuvers (ARM) are used to open atelectatic lung parenchyma, but the duration of their benefits has not been clearly determined. This study aims to determine the effectiveness of different PEEP levels after ARM in general anesthesia surgery, the duration of their time-dependent responses, and their hemodynamic effects, providing a reference for how often recruitment maneuvers should be performed during general anesthesia and further refining the specific details of lung-protective ventilation strategies.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
Double (Participant, Investigator)

入排标准

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

入选标准

  • ASA physical status classification: Ⅰ or Ⅱ or Ⅲ
  • Adults aged 18 to 80 years, regardless of gender.
  • Patients undergoing elective laparoscopic colorectal cancer surgery under general anesthesia.
  • Patients who have provided written informed consent after understanding the study purpose, procedures, and potential risks.

排除标准

  • Recent thoracic surgery; radiographic evidence of pneumothorax, emphysema, or pulmonary bullae;
  • Pulmonary diseases: asthma or severe obstructive ventilatory dysfunction; preoperative pulse oxygen saturation (SpO2) < 90% on room air or < 95% with supplemental oxygen; contraindications to ARMs (e.g., intracranial hypertension, hypovolemic shock, or right heart failure);
  • severe cardiac disease (NYHA class III/IV, acute coronary syndrome, sustained ventricular tachycardia); concurrent participation in another trial; or refusal to provide informed consent

结局指标

主要结局

the duration of improvement in lung compliance

时间窗: during the surgery

次要结局

未报告次要终点

研究者

发起方
Northern Jiangsu People's Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Ju Gao

Study Director

Northern Jiangsu People's Hospital

研究点 (1)

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