Multi-centre randomised controlled trial of the early use of non-invasive ventilation in acute exacerbations of chronic obstructive pulmonary disease (COPD)
| ISRCTN | ISRCTN31237955 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN31237955 |
| Secondary identifying numbers | H0020 ELLIOTT R&D |
- Submission date
- 23/01/2004
- Registration date
- 23/01/2004
- Last edited
- 25/02/2010
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Respiratory
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Mark Elliott
Scientific
Scientific
St James' University Hospital
Department of Respiratory Medicine
Ward 14
Beckett Street
Leeds
LS9 7TF
United Kingdom
| Phone | +44 (0)113 206 6037 |
|---|---|
| mark.elliott@lineone.net |
Study information
| Study design | Multi-centre randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Scientific title | |
| Study objectives | Acute exacerbations of COPD are a common reason for hospital admission and are a cause of significant mortality. Non-invasive ventilation (NIV) via a face or nasal mask has been shown to reduce mortality and the need for intubation. However the studies have been carried out in units with a particular expertise in the techniques involved. Instituting NIV in a distressed, dispnoeic individual and matching the ventilator to the patients requirements is difficult. The early introduction of NIV is easier (the patient is better able to cooperate and lower, more comfortable inflation pressures can be used) and may interrupt a vicious cycle of deterioration before it is well established. Moreover simpler ventilations, which do not require great expertise and are therefore practical for use in non-specialist units, can be used. We wish to establish whether early NIV can be widely applied, with benefit, in a variety of hospitals. |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Respiratory tract diseases: Chronic obstructive pulmonary disease |
| Intervention | Not provided at time of registration |
| Intervention type | Other |
| Primary outcome measure | Not provided at time of registration |
| Secondary outcome measures | Not provided at time of registration |
| Overall study start date | 31/12/1996 |
| Completion date | 31/12/1998 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Target number of participants | Not provided at time of registration |
| Key inclusion criteria | Not provided at time of registration |
| Key exclusion criteria | Not provided at time of registration |
| Date of first enrolment | 31/12/1996 |
| Date of final enrolment | 31/12/1998 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
St James' University Hospital
Leeds
LS9 7TF
United Kingdom
LS9 7TF
United Kingdom
Sponsor information
NHS R&D Regional Programme Register - Department of Health (UK)
Government
Government
The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
| Phone | +44 (0)20 7307 2622 |
|---|---|
| dhmail@doh.gsi.org.uk | |
| Website | http://www.doh.gov.uk |
Funders
Funder type
Government
NHS Executive Northern and Yorkshire (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 |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | cost effectiveness results | 03/05/2003 | Yes | No |
