Nocturnal nasal postive pressure ventilation plus oxygen therapy versus oxygen alone in severe stable chronic obstructive pulmonary disease
| ISRCTN | ISRCTN24818612 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN24818612 |
| Protocol serial number | 921019 |
| Sponsor | Hong Kong Health Services Research Fund (Hong Kong) |
| Funder | Hong Kong Health Services Research Fund (Hong Kong) |
- Submission date
- 10/10/2002
- Registration date
- 10/10/2002
- Last edited
- 01/07/2009
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- 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 DSC Hui
Scientific
Scientific
Department of Medicine & Therapeutics
Prince of Wales Hospital
Chinese University of Hong Kong
-
-
Hong Kong
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | |
| Study objectives | Not provided at time of registration |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Respiratory diseases |
| Intervention | Patients will then be randomized into two groups receiving: 1. Non-invasive positive pressure ventilation (NPPV) plus LTOT, or 2. LTOT plus oral placebo over a 3-month period. NPPV will be delivered via a portable bilevel positive airway pressure (BiPAP) Duet device via a nasal or oral-nasal mask. |
| Intervention type | Drug |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | oxygen |
| Primary outcome measure(s) |
Not provided at time of registration |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 31/12/2002 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Key inclusion criteria | Patients with severe stable chronic obstructive pulmonary disease with hypercapnic respiratory failure already on domiciliary long-term oxygen therapy (LTOT) |
| Key exclusion criteria | Does not meet inclusion criteria |
| Date of first enrolment | 01/01/2002 |
| Date of final enrolment | 31/12/2002 |
Locations
Countries of recruitment
- China
- Hong Kong
Study participating centre
Department of Medicine & Therapeutics
-
-
Hong Kong
-
Hong Kong
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
