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临床试验/NCT04712084
NCT04712084已完成不适用

Postoperative Atelectasis Prevention by Application of PEEP and Pressure Support Ventilation: a Prospective Randomized Controlled Trial

Lennart Magnusson0 个研究点目标入组 34 人开始时间: 2013年7月3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
34
主要终点
Atelectatic surface

研究概览

简要总结

General anaesthesia is known to promote lung collapse (atelectasis) which will persist in the postoperative period. Inflating the lung to a pressure of 40 cmH2O, called a vital capacity manoeuvre (VCM), performed a few minutes before extubation followed by the use of 40% of O2 will prevent postoperative atelectasis formation. This is not the case if VCM is followed by application of 100% of O2. However the use of 100% of O2 before tracheal extubation is still recommended for safety reason. Application of PEEP associated with pressure controlled ventilation before intubation prevents atelectasis formation despite the use of 100% of O2. The goal of our study was to show that performing a VCM 15 minutes before arousal followed by application of PEEP and pressure support ventilation (PSV) before and after tracheal extubation will prevent the recurrence of atelectasis despite the use of 100% of O2.

Materials and Methods With the ethic committee for research on human beings approval, the investigators randomly assigned 16 non-obese patients scheduled for a gynaecological laparoscopic surgery in two groups. At the end of the surgery the investigators performed a VCM (40cmH2O applied for 12 seconds), then O2 was increased to 100% in both groups. In the patients of the study group, a PEEP of 6 cmH2O was applied associated with a PSV of 8 cmH2O. This was continued after the extubation for 3 minutes. The O2 was then decreased to 40% and, when the expired oxygen saturation was < 50%, PEEP and PSV were removed. For the patients in the control group, no positive pressure was applied during spontaneous ventilation (PEEP = 0 and no PSV). The atelectasis were then measured by computed tomographic scanning.

详细描述

This is a prospective double-blinded study with prior informed written consent obtained from all patients.

Study Population Patients aged 18 to 65 years, American Society of Anesthesiologist (ASA) physical status classification I to III, undergoing gynaecological laparoscopic surgery under general anaesthesia were included in this prospective, randomised, double-blinded study.

Exclusion criteria were severe pulmonary disease, body mass index (BMI) more than 30 kg /m2 or less than 17, pregnancy or any other disease for which hypoxemia could be harmful. If the delay between extubation and the computed tomography (CT) scan was over 20 minutes, patients were also excluded.

Study treatments No premedication was given. General anaesthesia was standardized for all patients. Standard monitoring was applied. General anaesthesia was induced intravenously with fentanyl 1 to 2 μg/kg, propofol 2 to 3 mg/kg, and rocuronium 0.6 mg/kg. The airways were secured by endotracheal intubation.

Desflurane was used for maintenance at 1 minimal alveolar concentration (MAC) in 40% oxygen and air. Additional rocuronium was injected in order to maintain a train-of-four ratio (TOF ratio) between 0 and 1/4. Supplemental fentanyl was administered in order to maintain blood pressure and/or heart rate values within a range of 20% compared to baseline values.

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
Double (Participant, Outcomes Assessor)

盲法说明

Patient during general anesthesia are not aware of the technique applied. The radiologist calculating the surface of atelectasis is not aware of the technique applied

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • patient undergoing gynaecological laparoscopic surgery under general anesthesia

排除标准

  • BMI > 30 kg/m2 or < 17 kg/m2
  • pregnancy; hypoxemic disease
  • Delay between extubation and CT-scan > 20 minutes

结局指标

主要结局

Atelectatic surface

时间窗: 10 - 20 minutes after extubation

Whole lung CT scan with a special low doses protocol was obtained at end-expiratory position (at functional residual capacity)

次要结局

未报告次要终点

研究者

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

Lennart Magnusson

MD Lennart Magnusson PhD, PD

Hôpital Fribourgeois

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