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临床试验/NCT02173327
NCT02173327Unknown不适用

Continuously Helm CPAP Versus Intermittent Mask CPAP After Major Abdominal Surgery

Rigshospitalet, Denmark2 个研究点 分布在 1 个国家目标入组 102 人开始时间: 2013年11月最近更新:
适应症

试验速览

阶段
不适用
入组人数
102
试验地点
2
主要终点
PaO2/FiO2

研究概览

简要总结

Postoperative pulmonal complications (Abbreviation - PPC) after major abdominal surgery remains a significant clinical problem delaying rehabilitation after surgery. CPAP is one approach to minimize the frequency and severeness of PPC.

In the investigators' organization intermittent mask CPAP every 2 hour, 15min, is used routineously after major abdominal surgery.

Recently new devices has been designed, which give the opportunity tip deliver continuously CPAP with out interruptions because of presumed better comfort. Therefore better patient compliance.

No studies to date have investigated the possible benefit of using continuously helm CPAP versus the traditional intermittent mask CPAP after major abdominal surgery.

The investigators' study will investigate if there are any benefits with continuously Helm CPAP Versus intermittent Mask CPAP After Major Abdominal Surgery.

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
Single (Outcomes Assessor)

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

  • Elective major abdominal surgery

排除标准

  • Severe lung disease. Airway deformity. Need for CPAP at home. Ongoing oxygen therapy. Cannot give informed consent.

结局指标

主要结局

PaO2/FiO2

时间窗: 24 hours

Measured 6,12 and 18 hours after surgery

次要结局

  • V/Q mismatch(24 hours)
  • Postoperative complications(30 days)
  • Length of stay(30 days)
  • Admittance to the intensive care unit(30 days)
  • Mortality(30 days)

研究者

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

Klaus Vennick Marcussen

MD

Rigshospitalet, Denmark

研究点 (2)

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