NCT01371149已完成2 期
A Clinical Trial to Optimise Patient-ventilator Interaction in Patients With Chronic Respiratory Failure
Michelle Ramsay4 个研究点 分布在 1 个国家目标入组 58 人开始时间: 2011年1月最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 58
- 试验地点
- 4
- 主要终点
- Adherence with ventilation
研究概览
简要总结
To evaluate a novel advanced physiological monitoring system to improve nocturnal non-invasive ventilation (NIV) in Neuromuscular disease (NMD), Chest wall disease (CWD), Chronic Obstructive Pulmonary Disease (COPD) and Obesity Hypoventilation Syndrome (OHS) patients. By enhancing sleep comfort, adherence to ventilation will increase which, in turn, will improve ventilatory failure, quality of life and reduce length of admission during initiation of therapy. We aim to incorporate this technology into routine clinical practice.
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
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients over the age of 16 years.
- •Patients with confirmed diagnosis of Duchenne Muscular dystrophy or Chronic Obstructive Pulmonary Disease or Obesity Hypoventilation Syndrome.
- •Patients with evidence of nocturnal hypoventilation with an arterial carbon dioxide partial pressure of >6.0 kPa in the morning.
- •Patients with evidence of hypercapnic respiratory failure with an arterial carbon dioxide partial pressure of >6.0 kPa during the day.
- •No prior domiciliary ventilation.
排除标准
- •Patients with other co-morbidities e.g. cancer or cardiac failure.
- •Patients with muscular weakness but an unconfirmed diagnosis of Duchenne Muscular Dystrophy, Obesity Hypoventilation Syndrome or Chronic Obstructive Pulmonary Disease.
- •Patients who have had an acute illness within the last 4 weeks prior to starting assessment for ventilation.
- •Patients who have an abnormal bleeding tendency (INR or APTTr >1.4 or platelets <100).
- •Patients with a psychological, social or geographical situation that would impair compliance with the project.
结局指标
主要结局
Adherence with ventilation
时间窗: 3 months
Data on patient reported compliance and ventilator recorded compliance will be collected.
次要结局
- length of hospital stay for initiation of home mechanical ventilation(3 months)
- gas exchange(3 months)
- health related quality of life(3 month)
研究者
Michelle Ramsay
Dr
Guy's and St Thomas' NHS Foundation Trust
研究点 (4)
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