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临床试验/NCT01316575
NCT01316575已完成不适用

Prophylactic Nasal Continuous Positive Airway Pressure (nCPAP) Following Bowel Surgery

University of Saskatchewan0 个研究点目标入组 40 人开始时间: 2011年4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
40
主要终点
Alveolar - Arterial Gradient

研究概览

简要总结

The purpose of this study is to determine whether prophylactic nasal continuous positive airway pressure (nCPAP) in the post-anaesthesia care unit (PACU) improves post-operative pulmonary function following elective bowel surgery. The investigators hypothesize that one hour of nCPAP in the PACU will result in a higher partial pressure of arterial oxygen (PaO2) when compared to the standard treatment of low flow oxygen applied by face mask.

详细描述

Post-operative pulmonary complications, such as hypoxemia, pneumonia and respiratory failure, occur in 5-10% of patients following abdominal surgery. These post-operative pulmonary complications result in increased morbidity, mortality, ICU admission, length of hospital stay and resource use.

CPAP has shown to be an effective treatment for hypoxemia following abdominal surgery. It decreases atelectasis formation the risk of pneumonia. Application of nCPAP to treat hypoxemic respiratory failure following thoraco-abdominal surgery has shown to decrease endotracheal intubation.

Nasal CPAP has shown to be effective prophylaxis following elective cardiac and thoraco-abdominal aortic surgery. It reduces the incidence of hypoxemia, pneumonia, re-intubation and re-admission to the ICU. It has also shown to decrease the length of hospital stay.

The use of nCPAP immediately post-operatively in the PACU following abdominal surgery has not been evaluated. Nasal CPAP is better tolerated than full face mask CPAP. It allows for effective clearance of respiratory secretions, improved communication and decreases claustrophobic sensation. The PACU is a transition period from general anaesthesia into the post-operative recovery phase. During this time, residual anaesthetic causes decreased level of consciousness and sub-optimal respiratory effort. Reversal agent for neuromuscular blockade has often not reached its peak effect. Inadequate pain control may further decrease respiratory effort. This transition period may be when maximal atelectasis of alveolar lung units occurs. This time period may be optimal for the application of nCPAP for prophylaxis against hypoxemia. It may improve post-operative pulmonary function which could decrease post-operative morbidity, mortality, length of hospital stay and resource use.

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

  • Patients scheduled to undergo elective laparotomy for bowel surgery

排除标准

  • age < 18 years
  • postoperative admission to the intensive care unit
  • a history of allergy/intolerance to Ametop

研究组 & 干预措施

nCPAP

Experimental

The experimental group will receive nasal CPAP at 10cmH20 for one hour in the Post Anesthetic Care Unit.

干预措施: nCPAP (Device)

Low Flow Oxygen

Active Comparator

The control group will receive standard therapy of low flow oxygen via simple mask at 8 litres per minute.

干预措施: Low Flow Oxygen (Device)

结局指标

主要结局

Alveolar - Arterial Gradient

时间窗: 1 hour following admission to PACU

The alveolar - arterial gradient is the difference between the partial pressure of alveolar oxygen and the partial pressure of arterial oxygen

次要结局

  • Length of Stay in Hospital(Up to 2 weeks)
  • Number of Participants Requiring Reintubation(Up to 2 weeks)
  • Number of Participants Requiring Admission to ICU(Up to 2 weeks)

研究者

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

William McKay

Anesthesiologist

University of Saskatchewan

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