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临床试验/NCT02548416
NCT02548416已完成不适用

Peroperative Use of Positive End-expiratory Pressure Prevents Formation of Atelectasis as Studied by Computerised Tomography at End of Surgery

Region Västmanland1 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2015年11月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
24
试验地点
1
主要终点
Measurement of aeras with different aeration in the particular CT scan.

研究概览

简要总结

Atelectasis is common during and after general anaesthesia and a number of interventions have been suggested in order to prevent their formation. The use of Positive End Expiratory Pressure (PEEP) during general anaesthesia has in recent years been questioned.

The investigators hypothesize that the use of PEEP as a single intervention improves oxygenation and prevents atelectasis as investigated by computed tomography compared to a control group with zero PEEP.

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)

入排标准

年龄范围
40 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Healthy subjects, American Society of Anesthesiology (ASA) I-II.
  • Patients scheduled for non-abdominal day case surgery under general anaesthesia.

排除标准

  • ASA class III or higher.
  • Body Mass Index (BMI) 30 or higher.
  • Arterial oxygen saturation (SpO2) <96% breathing air.
  • Chronic Obstructive Pulmonary Disease (COPD).
  • Ischaemic heart disease.
  • Known or anticipated difficult airway.
  • Active smokers and ex-smokers with a history of more than 6 pack years.
  • Need for interscalene or supraclavicular plexus block for postoperative pain relief (risk of phrenic nerve paralysis).

结局指标

主要结局

Measurement of aeras with different aeration in the particular CT scan.

时间窗: Within 1-2 hours, just before emergence from anesthesia.The outcome measure (atelectasis) will be investigated at just one point i.e. end of surgery but before emergence from anaesthesia.

The areas of different aeration are assessed by computed tomography (CT) 5-10 mm above the dome of the right diaphragm and expressed in centimeter\^2 and as a percentage of the total lung area in the particular scan.

Area of atelectasis expressed as centimeter^2

时间窗: Within 1-2 hours, just before emergence from anesthesia.The outcome measure (atelectasis) will be investigated at just one point i.e. end of surgery but before emergence from anaesthesia.

The area of atelectasis in the lungs is assessed by computed tomography (CT) 5-10 mm above the dome of the right diaphragm and expressed in centimeter\^2 and as a percentage of the total lung area in the particular scan.

次要结局

  • Oxygenation, oxygen tension in arterial blood expressed in kilo Pascal (kPa)(Within 2 hours perioperatively, 15 minutes after extubation.)

研究者

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

Erland Ostberg

M.D.

Region Västmanland

研究点 (1)

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