跳至主要内容
临床试验/NCT01900990
NCT01900990已完成不适用

A Randomized Controlled Trial of Noninvasive Positive Pressure Ventilation for Weaning From Mechanical Ventilation in Tracheotomy Patients

Chongqing Medical University2 个研究点 分布在 1 个国家目标入组 32 人开始时间: 2009年7月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
32
试验地点
2
主要终点
Main end-point defined as total duration of mechanical ventilation

研究概览

简要总结

The investigators adopt Noninvasive Positive Pressure Ventilation for weaning in tracheotomy patients innovatively. The investigators randomly allocate the subjects into two groups. One group is weaned by traditional strategy. The other one is weaned by Noninvasive Positive Pressure Ventilation by plugging the tracheotomy tube and deflating the cuff.

详细描述

The investigators adopt Noninvasive Positive Pressure Ventilation for weaning in tracheotomy patients innovatively .If patients'conditions met our defined criterions, the investigators randomly allocate two groups. One group adopts traditional weaning strategy, the other adopts Noninvasive Positive Pressure Ventilation. If patients' condition deteriorated in group two, the investigators turned them to invasive positive pressure ventilation, until patients adapted in a satisfactory condition, the investigators shift them into Noninvasive Positive Pressure Ventilation. The investigators will extubate the tracheotomy tube, if patients are received Noninvasive Positive Pressure Ventilation more than 24 to 48 hours. After extubation, the investigators try to wean Noninvasive Positive Pressure Ventilation. Successful wean is defined weaning mechanical ventilation more than 48 hours.

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
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

  • age ≥ 18 years
  • tracheotomy mechanical ventilation patients

排除标准

  • pregnancy
  • respiratory and hemodynamic instability
  • Recent oral,nasal,facial or cranial trauma or surgery
  • contra-indications for nasal or facial mask (facial skin lesions,...)
  • recent history of upper gastro-intestinal surgery
  • recent history of myocardial infarction
  • unconscious patients
  • non cooperative patient

结局指标

主要结局

Main end-point defined as total duration of mechanical ventilation

时间窗: from admission to hospital to discharge from it or death

The total duration of mechanical ventilation was measured from the patient admitted to hospital to discharge from it or death, an expected average of 2 months.

次要结局

  • duration of invasive mechanical ventilation(from admission to hospital to discharge from it or death)
  • duration of extubation tracheotomy tube(from admission to hospital to discharge from it or death)
  • total duration of mechanical ventilation (invasive and non invasive)(from admission to hospital to discharge from it or death)
  • successful weaning rate(from admission to hospital to discharge from it or death)
  • ICU length of stay(from admission to hospital to discharge from it or death)
  • hospital length of stay(from admission to hospital to discharge from it or death)

研究者

发起方
Chongqing Medical University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Duan jun

resident physician

Chongqing Medical University

研究点 (2)

Loading locations...

相似试验