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临床试验/NCT02216006
NCT02216006已完成不适用

High Fresh Gas Flow After Intubation - A Randomized Clinical Trial

Region Västmanland2 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2014年9月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
24
试验地点
2
主要终点
Atelectasis

研究概览

简要总结

Atelectasis is common during and after general anesthesia. Atelectasis develops early if preoxygenation with 100% oxygen is used and continuously used during induction until endotracheal intubation. The investigators hypothesize that a rapid anti-preoxygenation maneuver immediately after confirming a successful intubation, reduces the area of atelectasis as investigated by computed tomography compared to a standard procedure.

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 patients, American Society of Anesthesiology (ASA) I-II
  • Patients scheduled for orthopaedic day case surgery in general anaesthesia

排除标准

  • ASA class III or higher
  • Body Mass Index (BMI) 30 or higher
  • Arterial oxygen saturation (SpO2) <94% breathing air
  • Chronic Obstructive Pulmonary Disease (COPD)
  • Ischemic heart disease
  • Haemoglobin <100g/L
  • Known or anticipated difficult airway and/or intubation
  • Active smokers and ex-smokers with a history of more than 6 pack years
  • Need for interscalene or supraclavicular regional anaesthesia with risk of phrenic nerve paralysis

研究组 & 干预措施

Control group, conventional ventilatory settings

Active Comparator

Handling of the airway during induction and intubation is performed in a conventional manner.

Initial ventilatory settings are also done in a conventional manner.

干预措施: Control group, conventional ventilatory settings (Procedure)

High fresh gas flow, high minute ventilation

Active Comparator

Handling of the airway during induction and intubation is performed in a conventional manner.

Immediately after confirming a successful intubation the effect of preoxygenation is eliminated with an anti-preoxygenation maneuver.

干预措施: High fresh gas flow, high minute ventilation (Procedure)

结局指标

主要结局

Atelectasis

时间窗: Within 1-2 hours, just before emergence from anesthesia

The area of atelectasis in the lungs is assessed by computed tomography (CT) 10 mm above the dome of the right diaphragm and expressed in cm2 and as % of the total lung area in the particular scan.

次要结局

  • Arterial blood gases(Within 2-3 hours perioperatively)

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 (2)

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