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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, Amiens1 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
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
19
试验地点
1
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

研究组 & 干预措施

Pressure support ventilation

Active Comparator

Patients in this group are ventilated during the night (10 PM to 9 AM) with pressure support ventilation mode. The level of the pressure support is the same as the previous day.

During the day (9 AM to 10 PM), patients are ventilated with pressure support ventilation (the level of pressure support is progressively decreased).

干预措施: pressure support ventilation (Other)

Pressure controlled ventilation

Active Comparator

Patients in this group are ventilated during the night (10 PM to 9 AM) with pressure controlled ventilation mode. The level of inspiratory pressure is set to 20 cm H2O and the respiratory rate is adjusted to avoid any spontaneous breathing (respiratory rate > or equal to 12 breath per min). During the day (9 AM to 10 PM), patients are ventilated with pressure support ventilation (the level of pressure support is progressively decreased).

干预措施: Pressure controlled ventilation (Other)

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 (1)

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