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临床试验/NCT04877353
NCT04877353已完成不适用

Postoperative Noninvasive Ventilation After Upper Abdominal Surgery in Chronic Obstructive Lung Disease

South Valley University1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2019年1月1日最近更新:
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
100
试验地点
1
主要终点
acute respiratory events

研究概览

简要总结

In Qena university hospital a prospective, randomized study was carried out on 100 COPD patients, all were divided into; conventional therapy without NIV (C group) 50 patients or with prophylactic NIV(N group) 50 patients.NIV applied for approximately 30 to 45 min at 2- to 4-h intervals for 48 h following surgery . Primary endpoint was the acute respiratory events (ARE) .Secondary endpoints were acute respiratory failure (ARF), intubation rate, mortality rate, infectious and non-infectious complications, and ICU stay.

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 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Inclusion criteria:
  • •Age˃18 years, scheduled for upper abdominal surgery under general anesthesia.
  • •Moderate to very severe COPD (GOLD II to IV).
  • •ASA functional status II or greater.

排除标准

  • •Contraindications to the application of NIV.
  • •Sleep apnea syndrome.
  • •Facial deformation.
  • •Inability to follow the study.

研究组 & 干预措施

Group N

Experimental

50 patients.NIV applied for approximately 30 to 45 min at 2- to 4-h intervals for 48 h following surgery

干预措施: NIV (Device)

group C

No Intervention

50 patients recieved conventional oxygen therpy.

结局指标

主要结局

acute respiratory events

时间窗: 28days

patients %

次要结局

  • acute respiratory failure(28 days)
  • intubation rate(28 days)
  • ICU mortality(28 days)
  • ICU length of stay(28 days)
  • infectious and non infectious complications(28 days)

研究者

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

Asmaa Mohamed

PhD candidate _anesthesia ,ICU &pain management_Qena SVU

South Valley University

研究点 (1)

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