Impact of Humidification on Sleep Quality During Home Non Invasive Ventilation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Change from baseline in sleep quality at two month
研究概览
简要总结
Protocol Summary:
- Question Does the adjunction of a humidification system to non-invasive ventilation circuit improve sleep quality and comfort of chronic ventilated respiratory insufficient patients? Does it change the efficacy of long-term non invasive ventilation therapy and patient-ventilator interactions?
- Aims
Main aim:
The primary endpoint of this study is to objectively evaluate the consequences of a humidification system's adjunction on quality of sleep, 2 months after treatment's beginning.
Second aims:
The secondary endpoints are to evaluate the consequences of a humidification system's adjunction on non invasive ventilation's efficacy / patient-ventilator asynchronies / patients' comfort / treatment adherence.
Before the clinical trial, the investigators conducted a bench study using a mechanical lung in order to evaluate the ventilator's behavior with and without a humidification system.
The clinical trial will include patients with chronic respiratory failure with an indication of long-term non invasive ventilation therapy. Patients will be included in the Pulmonology, Thoracic Oncology and Respiratory intensive care unit of Rouen University Hospital.
It will be a prospective monocentric study, including consecutively all eligible patients. Informed consent will be obtained from all of them.
At baseline, patients will be hospitalized for two consecutive nights for non invasive ventilation's set up. During the first night, a polysomnography will be performed without non invasive ventilation. Then, patients will be treated by non invasive ventilation with a bi-level self-regulated pressure mode and an open circuit.
Patients will be randomized in two groups: without a humidification system and with a humidification system. Partitioning by the physiopathological pattern (obstructive versus obesity hypoventilation syndrome vs. neuromuscular disease) will be done.
During each night, arterial blood gases will be measured at bedtime and awakening. Patients will be monitored by:
- polysomnography (only during the first night)
- transcutaneous capnography
- accessory inspiratory muscles surface electromyography
- pneumotachograph on non invasive ventilation's circuit
- pressions measured at the mask.
Follow-up will take place at two months after non invasive ventilation's beginning with or without humidification. Patients will be hospitalized for one night only. Blood gases at bedtime and at awakening will be measured. A polysomnography with non invasive ventilation will be performed. Observance will be evaluated.
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
- None
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
- •Type 2 chronic respiratory failure (PaCO2 > 6,5 at the time of the diagnosis)
- •Indication of a long term non invasive ventilation at home because of an obstructive respiratory disease, a obesity hypoventilation syndrome or a neuromuscular disease.
- •Over eighteen years old
- •Planned hospitalisation to introduce non invasive ventilation.
排除标准
- •Less than eighteen years old
- •Pregnancy
- •Psychiatric or cognitive disorders in wich consent is not possible
- •Acute respiratory failure within 2 weeks before inclusion.
研究组 & 干预措施
Humidification
干预措施: Humidification (Device)
Control group without humidification
结局指标
主要结局
Change from baseline in sleep quality at two month
时间窗: Assessement will be performed at baseline and 2 month after initiation of non invasive ventilation with or without humidification.
Sleep quality will be assessed by polysomnography without non invasive ventilation at Baseline versus with non invasive ventilation at follow up with or without humification (after 2month)
次要结局
- Nature of patient-ventilator asynchrony(Assessement will be performed at baseline and 2 month after initiation of non invasive ventilation with or without humidification.)
- Comfort with non invasive ventilation(Assessement will be performed at baseline and 2 month after initiation of non invasive ventilation with or without humidification.)
- Subjective sleep quality(Assessement will be performed at baseline and 2 month after initiation of non invasive ventilation with or without humidification.)
- Number of patient-ventilator asynchrony(Assessement will be performed at baseline and 2 month after initiation of non invasive ventilation with or without humidification.)
- Quality of life: Severe Inspirator Insufficiency questionary(Assessement will be performed at baseline and 2 month after initiation of non invasive ventilation with or without humidification.)
- Rhinorrhea and xerostomia(Assessement will be performed at baseline and 2 month after initiation of non invasive ventilation with or without humidification.)
- Number of nightime disruption of non invasive ventilation(Assessement will be performed at baseline and 2 month after initiation of non invasive ventilation with or without humidification.)
- Adherence(Outcome will be assessed at study completion (two months follow-up).)
- Nasal obstruction(Assessement will be performed at baseline and 2 month after initiation of non invasive ventilation with or without humidification.)