Condition category
Mental and Behavioural Disorders
Date applied
12/05/2010
Date assigned
12/05/2010
Last edited
11/08/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Muhammad Rafiq

ORCID ID

Contact details

Royal Hallamshire Hospital
Glossop Road
Sheffield
S10 2JF
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

5372

Study information

Scientific title

Acronym

Evaluating CoughAssist

Study hypothesis

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

MREC approved, ref: 08/H1313/83

Study design

Single-centre randomised interventional prevention, process of care and treatment trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Treatment

Patient information sheet

Condition

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

Phase

Not Applicable

Drug names

Primary outcome measures

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 trial start date

26/05/2009

Overall trial end date

01/11/2011

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Not Specified

Target number of participants

Planned sample size: 40; UK sample size: 40

Participant 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

Recruitment start date

26/05/2009

Recruitment end date

01/11/2011

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Royal Hallamshire Hospital
Sheffield
S10 2JF
United Kingdom

Sponsor information

Organisation

Sheffield Teaching Hospitals NHS Trust (UK)

Sponsor details

Royal Hallamshire Hospital
Glossop Road
Sheffield
S10 2JF
United Kingdom

Sponsor type

Hospital/treatment centre

Website

http://www.sth.nhs.uk/

Funders

Funder type

Research organisation

Funder name

Motor Neurone Disease Association (UK) (ref: shaw/Apr08/6335)

Alternative name(s)

MNDA

Funding Body Type

private sector organisation

Funding Body Subtype

professional associations and societies

Location

United Kingdom

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes