A prospective randomised cross-over trial to examine the effect of auto variable positive airway pressure versus standard non-invasive positive pressure ventilation on stable chronic obstructive pulmonary disease-patients previously established on non-invasive ventilation
| ISRCTN | ISRCTN84977419 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN84977419 |
| Protocol serial number | P01033 |
| Sponsor | Papworth Hospital NHS Foundation Trust (UK) |
| Funder | ResMed |
- Submission date
- 03/08/2006
- Registration date
- 31/08/2006
- Last edited
- 14/12/2010
- 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 Nick Oscroft
Scientific
Scientific
Papworth Hospital
Papworth Everard
Cambridge
CB3 8RE
United Kingdom
| Phone | +44 (0)1480 364495 |
|---|---|
| nick.oscroft@papworth.nhs.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised crossover trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | |
| Study objectives | Auto Variable Positive Airway Pressure (AutoVPAP) is not as efficacious as Non-Invasive Positive Pressure Ventilation (NIPPV). |
| Ethics approval(s) | Approved by Huntingdon Research Ethics Committee (REC) on 5/09/2006 (reference number: 05/Q0104/118). |
| Health condition(s) or problem(s) studied | Chronic Obstructive Pulmonary Disease (COPD) |
| Intervention | AutoVPAP versus NIPPV |
| Intervention type | Other |
| Primary outcome measure(s) |
Nocturnal oxygenation |
| Key secondary outcome measure(s) |
Quality of life |
| Completion date | 15/12/2006 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Senior |
| Sex | All |
| Target sample size at registration | 25 |
| Key inclusion criteria | 1. Chronic Obstructive Pulmonary Disease (COPD) 2. Forced Expiratory Volume in One second (FEV1) more than 50% predicted value 3. Smoking history more than 20 pack years |
| Key exclusion criteria | 1. Aged over 80 years 2. No other significant lung disease |
| Date of first enrolment | 15/12/2005 |
| Date of final enrolment | 15/12/2006 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
Papworth Hospital
Cambridge
CB3 8RE
United Kingdom
CB3 8RE
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 | 01/07/2010 | Yes | No |
