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临床试验/NCT01911923
NCT01911923撤回不适用

Reduction in Postoperative Atelectasis by Continuous Positive Airway Pressure and Low Oxygen Concentration After Endotracheal Extubation.

Region Västmanland2 个研究点 分布在 1 个国家开始时间: 2013年8月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
撤回
试验地点
2
主要终点
Area of atelectasis

研究概览

简要总结

Atelectasis is common during and after general anesthesia. The investigators hypothesized that a ventilation strategy with a combination of 1) continuous positive airway pressure (CPAP) or positive end-expiratory pressure (PEEP) and 2) a reduced end-expiratory oxygen fraction (FETO2) before commencing mask ventilation with CPAP after extubation would reduce the area of postoperative atelectasis.

详细描述

During general anesthesia, the combination of reduced functional residual capacity (FRC), high inspiratory oxygen fraction (FIO2), and airway closure are the main factors implicated in the atelectasis, shunt and shunt-like effects that account for the majority of the impaired oxygenation seen during general anesthesia.

Previous studies have shown that formation of atelectasis during preoxygenation and induction of anesthesia can be avoided by adding a continuous positive airway pressure (CPAP) followed by a positive end-expiratory pressure (PEEP).During emergence from anesthesia, high concentrations of oxygen predispose to atelectasis formation. Even a recruitment maneuver, followed by ventilation with 100% oxygen with a PEEP/CPAP of 10 cm H2O until extubation, failed to improve postoperative oxygenation compared with that achieved with zero end-expiratory pressure (ZEEP).This failure may have been caused by the presence of lung regions with high oxygen concentrations.

The investigators hypothesized that by inducing and discontinuing anesthesia during CPAP/PEEP and deliberately reducing FIO2 after extubation, postoperative atelectasis would be reduced compared with standard protocols. To test our hypothesis, the investigators studied 1) a control group with no CPAP/PEEP and a FIO2 of 1.0 while breathing spontaneously after extubation, and 2) an intervention group that was on CPAP/PEEP of 6 cmH2O from induction to extubation and that received an FIO2 of 1.0 until extubation and then an FIO2 of 0.3 via a facemask while on CPAP after extubation.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Participant, Outcomes Assessor)

入排标准

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

入选标准

  • Adult patients up to 75 years of age.
  • American Society of Anesthesiologists (ASA) physical status class I-III.
  • Be able to climb two flight of stairs without stopping.
  • SpO2 of ≥ 94% when breathing air in the supine position.
  • A body mass index (BMI, weight in kilograms divided by the square of the height in meters) of < 31.

排除标准

  • Patients with chronic obstructive pulmonary disease.
  • Ex smokers if smoked more than 5 pack years.
  • Overt heart failure
  • Known or predicted difficult intubation.

研究组 & 干预措施

No CPAP/PEEP and 100 % oxygen

Active Comparator

This is the control group

干预措施: No CPAP/PEEP and 100 % oxygen (Procedure)

CPAP/PEEP and 30 % oxygen

Experimental

This is the intervention group

干预措施: CPAP/PEEP and 30 % oxygen (Procedure)

结局指标

主要结局

Area of atelectasis

时间窗: 30 minutes

The area of atelectasis is investigated by computed tomography of the lungs postoperatively

次要结局

  • Peripheral oxygen saturation (SpO2)(2 hours)

研究者

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

Lennart Edmark

M.D.

Region Västmanland

研究点 (2)

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