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临床试验/NCT01573481
NCT01573481已完成不适用

Pressure Controlled Ventilation Versus Pressure Support Ventilation During the Night: New Strategy of Mechanical Ventilation Weaning?

Centre Hospitalier Universitaire, Amiens2 个研究点 分布在 1 个国家目标入组 19 人开始时间: 2012年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
19
试验地点
2
主要终点
Weaning duration

研究概览

简要总结

The purpose of the study is to compare pressure controlled continuous mandatory ventilation versus pressure support ventilation during the night for weaning to mechanical ventilation in chronic obstructive pulmonary disease patients and their impact onto sleep quality.

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
Single (Participant)

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

  • The patient and/or legal representative of the patient has provided a written informed consent before inclusion in the study
  • The patients is hospitalized in respiratory and critical care unit (university hospital of AMIENS, FRANCE)
  • the patient is mechanically ventilated (ventilator model : puritan-bennett B840)
  • Pulmonary disease,chronic obstructive (Spirometry and Blood Gas Analysis in chronic state before admission)
  • stable cardiovascular status (cardiac frequency < 140 beats/min and systolic blood pressure : 90-160 mmHg without catecholamines)
  • midazolam < 0,05mg/kg/h
  • sufentanyl < 0,05µ/kg/h
  • the disorder that caused respiratory failure and prompted mechanical ventilation is treated
  • the clinician suspects the patient may be ready to begin the weaning process
  • inspiratory oxygen fraction (FiO2) < 50%
  • positive end-expiratory pressure < or equal 8cmH2O
  • during the day, the patient tolerate pressure support ventilation (pressure support level < 15cmH2O
  • respiratory frequency (FR) < 35 breaths/min
  • tidal volume (VT) > 5ml/kg
  • PaO2/FiO2 > 200 mmHg
  • FR/VT < 105 breaths/min/L

排除标准

  • sleep apnea, central
  • narcolepsy
  • Encephalopathy, Metabolic AND Encephalitis

结局指标

主要结局

Weaning duration

时间窗: between one to 21 days (the study will begin when patient presents weaning criteria and will stop 48 days after extubation.)

weaning duration in days (from the first day with spontaneous ventilation to extubation)

次要结局

  • weaning failure(48 hours)
  • Quantity and quality of sleep(1 to 21 days)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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