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临床试验/NCT03255356
NCT03255356Unknown不适用

International Multicentre Observational Trial of Perioperative Ventilatory Management in Cardiac Surgery

University Hospital, Caen10 个研究点 分布在 10 个国家目标入组 1,000 人开始时间: 2017年11月1日最近更新:
适应症

试验速览

阶段
不适用
入组人数
1,000
试验地点
10
主要终点
incidence of use prophylactic protective mechanical ventilation defined with with low tidal volume (6 to 8 ml / kg based on the ideal body weight)

研究概览

简要总结

The purpose of this study is to evaluate prospectively ventilatory practices in the perioperative cardiac surgery period.

详细描述

This is a International Multicentre Observational Trial on all adult cardiac surgery patients with cardiopulmonary bypass (CPB).

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

  • All consecutive cardiac surgery patients with CPB during one predefined period,
  • Elective or urgent surgery as defined by EuroSCORE2.

排除标准

  • Refusal of consent,
  • Pregnant women,
  • Age < 18 years,
  • Heart transplant, ECLS, ventricular assist
  • Emergency or salvage surgery as defined by EuroSCORE2

结局指标

主要结局

incidence of use prophylactic protective mechanical ventilation defined with with low tidal volume (6 to 8 ml / kg based on the ideal body weight)

时间窗: 1 day

percent

次要结局

  • incidence of postoperative pulmonary complications(1 month postoperatively)
  • incidence of using positive end-expiratory pressure(1 day)
  • incidence of using at least 2 alveolar lung recruitment manoeuvres(1 day)
  • incidence of using a protective ventilation bundle combining prophylactic protective mechanical ventilation and at least 2 alveolar recruitment manoeuvres(1 day)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (10)

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Ventilation in Cardiac Surgery | 临床试验