ISRCTN43911973已完成未知
Evaluation of the impact of a CoughAssist® mechanical in-exsufflator (MI-E) device on morbidity, quality of life and survival in patients with motor neurone disease (MND) using non-invasive ventilation (NIV)
Sheffield Teaching Hospitals NHS Trust (UK)0 个研究点目标入组 40 人开始时间: 2010年5月12日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 40
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •1. The patient should not have any serious medical problems, apart from MND, which may reduce life expectancy
- •2. The patient should be capable of giving informed consent and should not have evidence of any significant impairment of cognitive function
- •3. Patients with MND in respiratory failure meeting two of the following criteria indicating the need for NIV:
- •3.1. Nocturnal or daytime hypercapnia (arterial blood gas [ABG] partial pressure of carbon dioxide in the blood [PaCO2] greater than 6.0 kPa)
- •3.2. Nocturnal hypoxaemia (oxygen saturation [SaO2] less than 88% for 5 consecutive minutes of the time asleep)
- •3.3. Lung function tests - forced vital capacity (FVC) less than 60% predicted
- •3.4. Maximal expiratory pressure less than 60 cm H2O
- •3.5. Orthopnoea
- •3.6. Symptoms of hypersomnolence or non-refreshing sleep
- •4. The patient should have a main carer who is willing to assist the patient in following the treatment regimen
- •5. The patient must fulfill the El Escorial clinically or laboratory supported probable or definite criteria for MND
排除标准
- •1. Inability to tolerate NIV
- •2. Infringement of the contraindications of CoughAssist® (a history of bullous emphysema, susceptibility to pneumothorax or pneumo-mediastinum, or recent baratrauma)
- •3. Presence of a significant medical condition, other than MND, which may reduce life expectancy
- •4. Presence of significant impairment of cognitive function (for example, clinically overt fronto-temporal dysfunction which is clinically evident and noticeable to the family)
- •5. Participation in any other interventional trial
研究者
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