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