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临床试验/NCT01410149
NCT01410149已完成不适用

The Influence of Mode and Patient-ventilator Interaction on Sleep Quality in the ICU

Lawson Health Research Institute1 个研究点 分布在 1 个国家目标入组 13 人开始时间: 2007年4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
13
试验地点
1
主要终点
Sleep quality

研究概览

简要总结

Patients requiring mechanical ventilation in the ICU will undergo three consecutive nights of polysomnography to record sleep patterns while receiving three modes of mechanical ventilation; Proportional assist ventilation (PAV), Pressure support ventilation (PSV), Assist control ventilation (ACV), applied in random order. The purpose is to determine the effect of mode of mechanical ventilation on patient-ventilator asynchrony and sleep quality.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Treatment
盲法
Single (Outcomes Assessor)

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

  • •Age 18-75
  • •received mechanical ventilation >72 hours
  • •glasgow coma scale >10
  • •acute physiology score <13
  • •ready for partial ventilatory support: intact respiratory drive, PaO2/FiO2 ratio >200 on positive end expiratory pressure (PEEP) less than or equal to 5 cmH2O, and PH of 7.35 to 7.45
  • •sedation: analgesia at dose not higher than 0.01 mg/kg/hr morphine equivalent x 48 hours, sedation at dose not higher than 0.01 mg/kg/hr lorazepam equivalent x 72 hours.
  • •anticipate ongoing need for partial ventilatory support for the following 72 hours

排除标准

  • •Successful completion of spontaneous breathing trial
  • •Neurological injury, encephalopathy or abnormal EEG
  • •History of central sleep apnea
  • •General anaesthesia within 72 hours from study entry
  • •Requiring haloperidol >10 mg/24 hours
  • •hemodynamically unstable

研究组 & 干预措施

PAV

Active Comparator

Proportional Assist Ventilation (PAV+ on PB840 ventilator)

干预措施: PAV (Other)

ACV

Active Comparator

Assist Control/ Pressure limited Ventilation (on PB840 ventilator)

干预措施: ACV (Other)

PSV

Active Comparator

Pressure Support Ventilation (PSV on PB840 ventilator)

干预措施: PSV (Other)

结局指标

主要结局

Sleep quality

时间窗: 3 nights

Sleep fragmentation (number of arousals and awakenings/hr sleep), sleep architecture (% time asleep spent in Stage 1, 2, 3/4 and REM sleep)

次要结局

  • Patient-ventilator asynchrony(3 nights)

研究者

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

Karen Bosma

Principal Investigator

Lawson Health Research Institute

研究点 (1)

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