Randomised trial of nasal mask versus full-face mask for the application of non-invasive ventilation in patients admitted to Queen's Medical Centre with an acute exacerbation of chronic obstructive airways disease and hypercapnic respiratory failure
| ISRCTN | ISRCTN63026442 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN63026442 |
| Secondary identifying numbers | N0192095136 |
- Submission date
- 12/09/2003
- Registration date
- 12/09/2003
- Last edited
- 17/09/2012
- Recruitment status
- Stopped
- Overall study status
- Stopped
- Condition category
- Respiratory
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr WJ Kinnear
Scientific
Scientific
c/o Dr Kinnear's Secretary
Respiratory Department
D Floor South Block
University Hospital
Nottingham
NG7 2UH
United Kingdom
| Phone | +44 (0)115 924 9924 (41979) |
|---|
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Scientific title | |
| Study objectives | Is there any measurable difference in outcome when using a nasal mask versus full-face mask when using bilevel non-invasive ventilation to treat patients with acute exacerbations of chronic obstructive pulmonary disease (COPD) and hypercapnic respiratory failure? |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Chronic obstructive pulmonary disease (COPD) |
| Intervention | Not provided at time of registration 17/09/2012: Please note that this trial was stopped due to a lack of funding |
| Intervention type | Other |
| Primary outcome measure | Improvement of arterial blood gases at 1 h and 4 h, the length of time patients spend on the ventilator in the first 24 h, the comfort of the patient (visual analogue scale) and the survival to discharge. |
| Secondary outcome measures | Not provided at time of registration |
| Overall study start date | 15/01/2002 |
| Completion date | 01/06/2003 |
| Reason abandoned (if study stopped) | Lack of funding/sponsorship |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Target number of participants | 50 |
| Key inclusion criteria | Total number of subjects = 50. |
| Key exclusion criteria | Does not meet inclusion criteria |
| Date of first enrolment | 15/01/2002 |
| Date of final enrolment | 01/06/2003 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
c/o Dr Kinnear's Secretary
Nottingham
NG7 2UH
United Kingdom
NG7 2UH
United Kingdom
Sponsor information
Department of Health (UK)
Government
Government
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
| Website | http://www.doh.gov.uk |
|---|
Funders
Funder type
Hospital/treatment centre
Queens Medical Centre University Hospital NHS Trust (UK)
No information available
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 |
