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临床试验/NCT03165760
NCT03165760已完成不适用

Protective Mechanical Ventilation and Risk of Postoperative Complications in Abdominal Surgery

Mongi Slim Hospital0 个研究点目标入组 80 人开始时间: 2015年7月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
80
主要终点
Postoperative pulmonary complications

研究概览

简要总结

Randomized controlled trial, comparing two groups of 40 patients each scheduled for open major abdominal surgery. The intervention group was ventilated with a protective strategy consisting on a low Tidal volume (Vt) (6ml/kg of predicted body weight (PBW)), positive end expiratory pressure (PEEP) = 10 cm H2O and recruitment manoeuvres (RM) after disconnection from the ventilator, the control group had classic ventilation (Vt = 8 ml/kg of PBW, PEEP = 4 cmH2O and no RM).

详细描述

This randomized controlled trial, was approved by the institutional ethics committee of our hospital. Informed consent was obtained from all the participants before randomization. Investigators included 80 patients (40 in each group), ASA I or II, planned for open abdominal surgery lasting more than 2 hours under general anesthesia.

Patients were not included if they had specially acute respiratory disease, severe asthma or emphysema, sleep apnea syndrome, septic shock and body mass index (BMI) < 16 or > 35 Kg/m2. Participants were excluded in case of serious peroperative anesthetic complications or hemorrhagic shock.

Primary endpoint was postoperative pulmonary complications occurring within the first 7 days after surgery (defined as hypoxemia, Broncho-pneumopathy, pulmonary infiltrate, acute respiratory distress syndrome, atelectasis, pleural effusion).

Secondary endpoints for all participants were intra-operative complications (change in SpO2 when dropped less than 90%, hypotension <90 mmHg lasting more than 3 min, need for vasopressor administration, new arrhythmia), postoperative extrapulmonary complications (septic shock, postoperative surgical complications, heart disease complications). Investigators recorded for all participants length of hospital stay and mortality rate were .

Investigators randomly allocated patients before entering to the operating room to:

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
None

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

  • ASA I or II, planned for open abdominal surgery lasting more than 2 hours under general anesthesia

排除标准

  • Patients were not included if they had specially acute respiratory disease, severe asthma or emphysema, sleep apnea syndrome, septic shock and BMI < 16 or > 35 Kg/m
  • They were excluded in case of serious peroperative anesthetic complications or hemorrhagic shock.

结局指标

主要结局

Postoperative pulmonary complications

时间窗: Postoperative pulmonary complications within the first 7 days after surgery

Postoperative pulmonary complications occurring within the first 7 days after surgery (defined as hypoxemia, Broncho pneumopathy, pulmonary infiltrate, acute respiratory distress syndrome, atelectasis, pleural effusion)

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

Mhamed Sami Mebazaa

professor head of the anesthesiology-ICU departement

Mongi Slim Hospital

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