A randomised controlled trial to compare auto variable positive airway pressure ventilation with conventional non-invasive positive pressure ventilation in the treatment of hypercapnic ventilatory failure in chronic obstructive pulmonary disease
| ISRCTN | ISRCTN91892415 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN91892415 |
| Protocol serial number | P01032; National Research Register: N0542167931 |
| Sponsor | Papworth Hospital Foundation NHS Trust (UK) |
| Funder | ResMed |
- Submission date
- 15/06/2006
- Registration date
- 28/06/2006
- Last edited
- 03/05/2011
- 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 N Oscroft
Scientific
Scientific
Papworth Hospital
Papworth Everard
CB3 8RE
United Kingdom
| Phone | +44 (0)1480 830541 |
|---|---|
| nick.oscroft@papworth.nhs.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised cross over study |
| Secondary study design | Randomised controlled trial |
| Scientific title | |
| Study objectives | Auto variable positive pressure ventilation is as efficiacious as standard positve pressure ventilation |
| Ethics approval(s) | Huntingdon research ethics committee on 27/10/2005 (ref: 05/Q0104/118) |
| Health condition(s) or problem(s) studied | Chronic obstructive pulmonary disease (COPD) |
| Intervention | There are two groups: the first will receive either auto variable positive airway pressure ventilation (auto VPAP) and the second group will receive standard non-invasive positive pressure ventilation (NIPPV). After eight weeks the two groups will cross over. The patients will be randomised to start on either auto VPAP or NIPPV. The control group is the group receiving standard NIPPV. |
| Intervention type | Other |
| Primary outcome measure(s) |
Nocturnal oxygenation |
| Key secondary outcome measure(s) |
Pulmonary function |
| Completion date | 01/02/2007 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | All |
| Target sample size at registration | 40 |
| Key inclusion criteria | 1. Diagnosis of Chronic Obstructive Pulmonary Disease (COPD) 2. Forced expiratory volume in one second (FEV1) < 50% 3. Smoking history > 20 pack years 4. Hypercapnic ventilatory failure |
| Key exclusion criteria | 1. Age > 80 2. Body Mass Index (BMI) > 40 |
| Date of first enrolment | 16/12/2005 |
| Date of final enrolment | 01/02/2007 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
Papworth Hospital
Papworth Everard
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 | 01/12/2010 | Yes | No |
