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临床试验/NCT06296277
NCT06296277招募中不适用

Management of Mechanical Ventilation During Surgery: an International, Multicenter, and Observational Data Registry

Azienda Ospedaliera SS. Antonio e Biagio e Cesare Arrigo di Alessandria1 个研究点 分布在 1 个国家目标入组 10,000 人开始时间: 2026年3月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
10,000
试验地点
1
主要终点
Postoperative pulmonary complications (PPCs)

研究概览

简要总结

This is an investigator-initiated, international, multicenter, prospective, cross-sectional study that aims to 1) describe the incidence and types of postoperative pulmonary complications (PPCs), 2) describe patient demographics, baseline characteristics, and intraoperative ventilation management, 3) describe the occurrence of intraoperative adverse events (IAEs), and 4) their associations with PPCs, 5) assess the practice of intraoperative mechanical ventilation.

Patients will be eligible for participation if: 1) adult and 2) receiving intraoperative ventilation during general anesthesia for surgery. Patients receiving ventilation outside of an operating room as well as patients receiving intraoperative ventilation during extracorporeal life support will be excluded

详细描述

This is an investigator-initiated, international, multicenter, prospective, cross-sectional study The here proposed study aims to 1) describe the incidence and types of postoperative pulmonary complications (PPCs), 2) describe patient demographics, baseline characteristics, and intraoperative ventilation management, 3) describe the occurrence of intraoperative adverse events (IAEs), and 4) their associations with PPCs, 5) assess the practice of intraoperative mechanical ventilation.

Patients will be eligible for participation if: 1) adult and 2) receiving intraoperative ventilation during general anesthesia for surgery. Patients receiving ventilation outside of an operating room as well as patients receiving intraoperative ventilation during extracorporeal life support will be excluded.

The primary endpoint is to report the number of patients with PPCs occurring in the first 5 postoperative days. As secondary endpoint, the practice of mechanical ventilation in patients undergoing general anesthesia for surgery will be ascertained including key intraoperative ventilator characteristics and respiratory system mechanics. Other secondary endpoints will include: incidence and type of IAEs; postoperative complications other than PPCs in the first 5 postoperative days; intensive care unit (ICU) admission and length of stay, hospital length of stay, and hospital mortality on day 28.

Participating hospitals have the flexibility to choose a specific time period for data collection, but it is imperative that this process occurs within 8 weeks from receiving approval by the local Ethics Committee. Furthermore, each participating center will conduct data collection during a predetermined 7-day period. Local investigators will capture data in an electronic case recording form, including patient demographics and baseline characteristics, intraoperative ventilator settings and ventilation parameters, and outcomes.

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

  • Adults; and
  • Receiving intraoperative IMV (via tracheal intubation, or supraglottic device ) during general anesthesia for surgery

排除标准

  • Receiving intraoperative IMV outside of an operating room; and
  • Receiving intraoperative IMV during extracorporeal life support

结局指标

主要结局

Postoperative pulmonary complications (PPCs)

时间窗: within 5 days after surgery

Incidence and type of PPCs

次要结局

  • Intraoperative mechanical ventilation practice(Intraoperatively)
  • Postoperative clinical outcome(Postoperatively, on day 28 following surgery)
  • Intraoperative adverse events (IAEs)(Intraoperatively)

研究者

发起方
Azienda Ospedaliera SS. Antonio e Biagio e Cesare Arrigo di Alessandria
申办方类型
Other
责任方
Principal Investigator
主要研究者

Gianmaria Cammarota

Prof Gianmaria Cammarota

Azienda Ospedaliera SS. Antonio e Biagio e Cesare Arrigo di Alessandria

研究点 (1)

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