跳至主要内容
临床试验/NCT00479284
NCT00479284已完成不适用

Contribution of Average Volume Assured Pressure Support (AVAPS) to Efficacy of bi-Level Pressure Support Nocturnal Ventilation and Impact on Sleep Structure

University Hospital, Geneva1 个研究点 分布在 1 个国家目标入组 14 人开始时间: 2006年6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
14
试验地点
1
主要终点
Quality of sleep

研究概览

简要总结

Patients with chronic hypercapnic respiratory failure can be successfully treated with home nocturnal non-invasive ventilation. Bi-level pressure support ventilators are at present the most frequently used ventilators for long term home ventilation. A recently commercialized bi-level ventilator offers the feature of automatically adjusting pressure support on the basis of a pre-determined ideal effective ventilation. Because this option may induce important swings in pressure support, and thus patient discomfort, and maybe increase leaks, we chose to analyse the impact of average volume assured pressure support (AVAPS) on patient comfort, subjective and objective quality of sleep and efficacy of ventilatory support.

详细描述

This study aims to compare, in a randomized order, two consecutive nights with a bi-level positive pressure ventilator (Synchrony, Respironics, USA), with and without average volume assured pressure support (AVAPS), in patients with chronic respiratory failure, treated on a long term basis by home nocturnal non-invasive ventilation.

Specific endpoints are :

  • quality of sleep assessed by polysomnography scored by an independent investigator (sleep efficiency, distribution of sleep stages, arousals and sleep stage changes) and subjective scores (St Mary's questionnaire),
  • perception of comfort of ventilation (clinical score),
  • efficacy of ventilation (pulsoximetry, transcutaneous capnography (Tina TCM4 Radiometer, Copenhagen), effective ventilation and tidal volumes, leaks as measured by ventilator, Stardust software, Respironics).

Patients: Fourteen patients with obesity-hypoventilation and/or COPD, treated and stable for at least 3 months, will be included and undergo complete sleep studies in Geneva University Hospital's Sleep Laboratory. Patients included must be compliant to treatment (at least 4 hours of use of ventilator/night).

Methods: Patients are blinded as to whether or not AVAPS is implemented. Target tidal volume is set at 7-8 ml/kg. EPAP (Expiratory positive airway pressure) level is unchanged. Minimal IPAP (Inspiratory positive airway pressure) level is set at usual IPAP - 3 cm H2O. Maximal IPAP is set between 25 and 30 cm H2O. Back up frequency is unchanged.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Crossover
主要目的
Supportive Care
盲法
Single

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

  • •Patients treated for chronic hypercapnic respiratory failure by home bi-level positive pressure non-invasive ventilation for at least 3 months, in a stable clinical condition

排除标准

  • •Poor compliance (< 4 hours/day) to home ventilation or recent episode ( < 3 months) of cardiac or respiratory failure necessitating hospitalization

结局指标

主要结局

Quality of sleep

时间窗: One night

Efficacy of ventilation

时间窗: One night

次要结局

  • Patient comfort(One night)

研究者

申办方类型
Other

研究点 (1)

Loading locations...

相似试验