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)
| ISRCTN | ISRCTN43911973 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN43911973 |
| Secondary identifying numbers | 5372 |
- Submission date
- 12/05/2010
- Registration date
- 12/05/2010
- Last edited
- 13/04/2017
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Mental and Behavioural Disorders
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Muhammad Rafiq
Scientific
Scientific
Royal Hallamshire Hospital
Glossop Road
Sheffield
S10 2JF
United Kingdom
Study information
| Study design | Single-centre randomised interventional prevention, process of care and treatment trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Other |
| Study type | Treatment |
| Scientific title | 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) |
| Study acronym | Evaluating CoughAssist |
| Study objectives | Without active management of respiratory symptoms, the majority of patients with motor neurone disease (MND) die within approximately 3 - 5 years, from neuromuscular respiratory failure. The applicants have previously shown that non-invasive ventilation (NIV) has a significant positive effect on the quality of life as well as prolonging the survival of MND patients, particularly in patients without severe bulbar dysfunction. However, increasing life expectancy by starting patients on NIV can uncover other downstream problems and a major problem for the patient is the inability to cough effectively. Poor cough can result in chest infections and airway blockage and pulmonary collapse. These problems lead to increasing respiratory failure and often require repeated hospital admissions. The aim of the present study is to determine whether the use of a mechanical CoughAssist® device can reduce the symptoms of chest infections and therefore hospital admissions whilst improving the quality of life and survival of patients with MND who need to be started on using non-invasive ventilation (NIV). 40 MND patients who require NIV will be assigned to one of two groups via a process of minimisation. One cohort will be assigned to receive NIV and be taught how to use breath-stacking. The other cohort will be assigned to receive NIV and be given the use of a mechanical in-exsufflator (MI-E) (CoughAssist®) machine. Patients will be reviewed every 3 months for 1 year. Outcome measures include the number of days with symptoms of chest infection, number of days in hospital due to chest infection, quality of life measures, measures of respiratory and neuromuscular function, survival of the patient and the impact of the intervention on the carer. Power calculations are based on the best information available in the literature regarding the number of days of hospitalisation expected for MND patients started on NIV. All outcome measures will be analysed by intention to treat; tests of significance will be two-sided. |
| Ethics approval(s) | MREC approved, ref: 08/H1313/83 |
| Health condition(s) or problem(s) studied | Topic: Dementias and Neurodegenerative Diseases Research Network; Subtopic: Motor neurone disease; Disease: Motor neurone disease |
| Intervention | CoughAssist® mechanical in-exsufflator versus breath stacking technique. Study entry: single randomisation only |
| Intervention type | Device |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | |
| Primary outcome measure | Number of days with symptoms of chest infections requiring antibiotic therapy |
| Secondary outcome measures | 1. Number of days in as a hospital inpatient due to chest infection 2. Quality of life (36-item short form health survey [SF-36]) |
| Overall study start date | 26/05/2009 |
| Completion date | 01/11/2011 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Not Specified |
| Target number of participants | Planned sample size: 40; UK sample size: 40 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 26/05/2009 |
| Date of final enrolment | 01/11/2011 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Royal Hallamshire Hospital
Sheffield
S10 2JF
United Kingdom
S10 2JF
United Kingdom
Sponsor information
Sheffield Teaching Hospitals NHS Trust (UK)
Hospital/treatment centre
Hospital/treatment centre
Royal Hallamshire Hospital
Glossop Road
Sheffield
S10 2JF
England
United Kingdom
| Website | http://www.sth.nhs.uk/ |
|---|---|
"ROR" |
https://ror.org/018hjpz25 |
Funders
Funder type
Research organisation
Motor Neurone Disease Association (UK) (ref: shaw/Apr08/6335)
Private sector organisation / Associations and societies (private and public)
Private sector organisation / Associations and societies (private and public)
- Alternative name(s)
- MND Association, MNDA
- Location
- United Kingdom
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/08/2015 | Yes | No |
Editorial Notes
13/04/2017: Publication reference added.
