临床试验/NCT04229810

NCT04229810Unknown不适用

Individualized Perioperative Open Lung Ventilatory Approach in Emergency Abdominal Laparotomy. A Prospective Multicenter Randomized Controlled Trial.

Hospital Clinic of Barcelona0 个研究点目标入组 732 人开始时间: 2020年9月15日最近更新: 2020年1月18日

适应症

试验速览

阶段: 不适用
发起方: Hospital Clinic of Barcelona
入组人数: 732
主要终点: Severe postoperative pulmonary complications

研究概览研究设计入排标准结局指标研究者记录与标识符相似试验

研究概览

简要总结

Prospective multicenter randomized controlled trial. Individualized perioperative open lung ventilatory approach in emergency abdominal laparotomy.

研究设计

研究类型: Interventional
分配方式: Randomized
干预模型: Parallel
主要目的: Prevention
盲法: Single (Participant)

入排标准

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

入选标准

•Adult men and women ≥18 years of age who underwent emergency laparotomy with the presence of post-induction positive air-test (SpO2 <97% after a maximum of 15 minutes at FIO2 of 0.21). A SpO2 <97% at any FIO2 would also be considered a positive air-test.

排除标准

•Pregnancy or breast feeding, 2) Moderate or severe ARDS defined, 3) refractory shock, 4) diagnosis or suspected intracranial hypertension (>15mmHg), 5) mechanical ventilation in the last 15 days (including CPAP), 6) presence of pneumothorax or giant bullae in a chest radiograph or computed tomography (CT), 7) patients participating in another intervention study with the same or similar primary outcome variable.

结局指标

主要结局

Severe postoperative pulmonary complications

时间窗: 7 days

A composite of severe postoperative pulmonary complications appearing during the first 7 postoperative days. Postoperative pulmonary complication will include any of the following: 1) Respiratory failure, 2) Pneumothorax, 3) Weaning failure, 4) Acute respiratory distress syndrome (ARDS), 5) Pulmonary infection.

次要结局

未报告次要终点

研究者

发起方

Hospital Clinic of Barcelona

申办方类型

Other

责任方

Principal Investigator

主要研究者

Carlos Ferrando Ortolá

Head of Surgical Intensive Care Unit

Hospital Clinic of Barcelona

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