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临床试验/NCT07431242
NCT07431242尚未招募不适用

Time-Dependent Exposure to Intraoperative Mechanical Power and Driving Pressure and Postoperative Pulmonary Outcomes in Laparoscopic Surgery

Istinye University1 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2026年2月25日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
90
试验地点
1
主要终点
Postoperative Pulmonary Complications (PPCs)

研究概览

简要总结

Postoperative pulmonary complications (PPCs) remain an important cause of morbidity after abdominal surgery. Intraoperative mechanical ventilation may contribute to lung injury through the mechanical load applied to the respiratory system. Mechanical power (MP) and driving pressure (DP) have emerged as integrative parameters reflecting the total ventilatory burden delivered to the lungs.

This prospective observational study aims to evaluate the association between time-dependent exposure to intraoperative mechanical power and driving pressure and postoperative pulmonary outcomes in patients undergoing elective laparoscopic abdominal surgery. Ventilatory parameters will be recorded at predefined intervals during routine clinical care, and MP and DP will be calculated without altering clinical management. The primary objective is to assess whether longer exposure to elevated ventilatory load is associated with the development of postoperative pulmonary complications.

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 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age ≥ 18 years
  • Scheduled for elective laparoscopic abdominal surgery under general anesthesia
  • Intraoperative mechanical ventilation with volume-controlled ventilation
  • Provision of written informed consent

排除标准

  • Emergency surgery
  • Conversion to open surgery
  • Preoperative invasive or noninvasive mechanical ventilation
  • Intraoperative major complications requiring substantial deviation from routine ventilation management
  • Incomplete intraoperative or postoperative data
  • Refusal or inability to provide informed consent

结局指标

主要结局

Postoperative Pulmonary Complications (PPCs)

时间窗: Within 72 hours after surgery

Occurrence of postoperative pulmonary complications within the early postoperative period, including prolonged oxygen requirement, hypoxemia (SpO₂ \< 92% on room air), need for non-invasive ventilation, or reintubation. PPC will be recorded as a composite binary outcome (present/absent).

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

İlke Dolgun

Assoc. prof

Istinye University

研究点 (1)

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