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临床试验/NCT03506906
NCT03506906已完成不适用

The Debated Role of Sleep Studies in Patients Under Established Home Mechanical Ventilation

Wissenschaftliches Institut Bethanien e.V2 个研究点 分布在 1 个国家目标入组 105 人开始时间: 2018年11月11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
105
试验地点
2
主要终点
Adjustment of non-invasive ventilation

研究概览

简要总结

Patients suffering chronic hypercapnic respiratory insufficiency (e.g. in chronic obstructive pulmonary disease, obesity hypoventilation syndrome) benefit from home mechanical ventilation. These patients are complex; and the ventilator´s parameters should be set-up according to the underlying disease and particular patient's characteristics. The non-invasive ventilation therapy is mostly titrated while the patient is awake, hence Problems, such as Patient-Ventilator asynchrony, arising while sleeping on the ventilator therapy would remain undetected.

Sleep studies, such as polysomnography or polygraphy and transcutaneous carbon dioxide monitoring could be valuable tools to fine-tune the ventilator's settings. This could foster the ventilator´s effectivity and patient satisfaction, thus therapy's adherence. Nevertheless the sleep studies are expensive, time-consuming and not widely available.

The aim of this study is to learn the findings of sleep studies when they are performed on stable patients on home mechanical ventilation as part of their routine check-ups. In this context, it will be assessed whether the sleep studies' findings lead to a change (adjustment) of the ventilator´s therapy. Moreover, this study aims to investigate whether the absence of sleep studies would result in missing important events that require an adjustment of therapy. The results of this study could provide information that lead to a more standardized protocol of follow-up checks of patients on home mechanical ventilation in a cost-effective manner.

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
Triple (Participant, Investigator, Outcomes Assessor)

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

  • Patients with chronic hypercapnic respiratory failure secondary to one or more identified condition(s) (chronic obstructive pulmonary disease, obesity hypoventilation syndrome, neuromuscular diseases, restrictive lung diseases)
  • Home mechanical ventilation for ≥ 6 months
  • Stable condition for ≥ 1 month

排除标准

  • Previous adjustment of the noninvasive ventilation therapy under sleep studies in the last 6 months
  • Current respiratory exacerbation
  • Any current comorbidity decompensation
  • Any medical or psychological condition impairing the patient's ability to provide informed consent
  • Missing signed informed consent
  • Total sleep time during polysomnography <180 min

结局指标

主要结局

Adjustment of non-invasive ventilation

时间窗: One day

Each case will be evaluated separately by 2 investigators. One of them will be provided with the diurnal evaluations only (as routinely); the second investigator will additionally have access to the sleep studies. Each investigator will classify the case as one of the following labels (primary outcome): 1. Non-invasive ventilation therapy optimization is not required (all ventilator's parameters should stay unchanged) 2. Optimization of non-invasive ventilation therapy is required (one or more of the ventilator's parameters should be re-set, irrespective of the magnitude)

次要结局

  • Health-related quality of life: questionnaire(6 months)
  • arterial level of carbon dioxide(6 months)
  • Non-invasive ventilation compliance(6 months)

研究者

发起方
Wissenschaftliches Institut Bethanien e.V
申办方类型
Other
责任方
Sponsor

研究点 (2)

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