Randomised controlled trial of closed circuit Continuous Positive Airway Pressure (CPAP) and open circuit CPAP with a Boussignac valve for the treatment of acute pulmonary oedema.
| ISRCTN | ISRCTN81164973 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN81164973 |
| Protocol serial number | N0013101032 |
| Sponsor | Department of Health |
| Funder | Guy's and St Thomas' NHS Trust (UK) |
- Submission date
- 30/09/2004
- Registration date
- 30/09/2004
- Last edited
- 10/07/2009
- 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 Peter Leman
Scientific
Scientific
Acute Medicine
St Thomas' Hospital
Lambeth Palace Road
London
SE1 7EH
United Kingdom
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | |
| Study objectives | This study will seek to determine whether the Boussignac valve system is as effective as conventional CPAP using a Drager CF800 circuit. |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Respiratory: Acute pulmonary oedema |
| Intervention | The patient will be randomised to one of two groups: 1. CPAP with the closed circuit Drager CF800 system OR 2. CPAP with the open circuit Vygon Boussignac valve system |
| Intervention type | Other |
| Primary outcome measure(s) |
The main outcome measure will be the PaCO2 at 30 and 60 minutes. Other outcome measures will be PaO2 at 30 and 60 minutes, need for intubation, and tolerance of mask/circuit. |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 31/12/2003 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Target sample size at registration | 50 |
| Key inclusion criteria | Patients with acute pulmonary oedema attending Accident and Emergency (A&E). We intend to recruit 50 patients to allow for recruitment errors and drop outs etc. |
| Key exclusion criteria | Does not meet inclusion criteria |
| Date of first enrolment | 01/10/2001 |
| Date of final enrolment | 31/12/2003 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
Acute Medicine
London
SE1 7EH
United Kingdom
SE1 7EH
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | 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 | 01/06/2005 | Yes | No |
