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)

Not Applicable

Completed

Conditions: Topic: Dementias and Neurodegenerative Diseases Research Network
Subtopic: Motor neurone disease
Disease: Motor neurone disease
Mental and Behavioural Disorders
Motor neurone disease

Registration Number: ISRCTN43911973

Lead Sponsor: Sheffield Teaching Hospitals NHS Trust (UK)

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 40

Inclusion Criteria

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

Exclusion Criteria

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