Initiation of Home Mechanical Ventilation at Home in a Selectve Group of Patients With Chronic Hypercapnic Respiratory Failure in the Netherlands
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 96
- 试验地点
- 2
- 主要终点
- Daytime arterial carbon dioxide
研究概览
简要总结
Objective: To prove that initiation of chronic ventilatory support at home, in patients with chronic hypercapnic respiratory failure due to neuromuscular disease (NMD) or thoracic cage problem is not inferior compared to initiation in a hospital based setting. In addition we believe that the start at home is cheaper compared to an in-hospital start.
Hypothesis: Initiation of chronic ventilatory support at home is effective, safe and cost effective compared to a hospital-based initiation.
Study design: A nationwide non-inferiority multi-center randomized parallel active control study.
Study population: Patients with chronic respiratory insufficiency due to a neuromuscular disease (NMD) or thoracic cage problem who are referred for chronic ventilator support.
Intervention: The start of HMV at home Standard intervention to be compared to: The start of HMV is normally in a clinical setting as recommended in the national guideline.
Outcome measures: Primary: PaCO2. Secondary: Health related quality of life; lung function; nocturnal transcutaneous carbon dioxide assessment and saturation, and costs Sample size calculation/data analysis: This is a non-inferiority trial based on PaCO2 as primary outcome. A difference in favor of the hospital care group of smaller than 0.5 kPa will be labeled as non-inferior. To retain 72 evaluable patients, and allow for drop-outs, we will include 96 patients in total.
Cost-effectiveness analysis: A cost analysis will be conducted alongside the clinical trial. Costs of the initiation of HMV at home and in the hospital will be estimated form a societal perspective over a time horizon of 6 months.
Time schedule: After an initial phase of 6 months recruitment will start and will take 24 months. Thirty-six months after the start of the study the last assessments will be done and analysis and writing of the papers will start. After 42 months the study will end.
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
- •Indication to initiate non-invasive ventilatory support in patients with a neuromuscular disease or thoracic cage abnormality who suffer from complaints of alveolar hypoventilation (fatigue, headache of dyspnoea) combined with all following elements:
- •arterial carbon dioxide > 6.0 kPa daytime or arterial or transcutaneous carbon dioxide > 6.0 kPa at night or orthopnea as a result of diaphragm paralysis
- •Age > 18 years
- •Existence, of a sufficient network (social or professional) according to the supervising HMV center making initiation of HMV at home possible and safe.
排除标准
- •Patients who already have had HMV due to acute respiratory failure
- •Necessity for invasive ventilatory support
- •Patients admitted to a nursing home
研究组 & 干预措施
Hospital initiation
Initiation of mechanical ventilation in hospital initiation of Home Mechanical ventilation takes place in a hospital; this makes this arm the standard care.
干预措施: Initiation of mechanical ventilation (Procedure)
Home initiation
Initiation of mechanical ventilation at home Initiation of mechanical ventilation in a patient's home setting with telemonitoring
干预措施: Initiation of mechanical ventilation (Procedure)
结局指标
主要结局
Daytime arterial carbon dioxide
时间窗: 6 months after initiation of mechanical ventilation
Daytime arterial carbon dioxide (PaCO2) assessed without oxygen supplementation and ventilatory support while the patient is in sitting position
次要结局
- Lung function(6 months after initation of mechanical ventilation)
- Quality of life(6 months after initiation of mechanical ventilation)
- Nocturnal transcutaneous carbon dioxide and saturation(6 months after initiation of mechanical ventilation)
- costs(6 months after initiation of mechanical ventilation)
研究者
Peter Wijkstra
professor
University Medical Center Groningen