Domiciliary application of non-invasive positive pressure ventilation with average volume assured pressure support to subjects with chronic obstructive pulmonary disease (COPD) who remain hypercapnic following the application of non-invasive positive pressure ventilation (NPPV) for an acute exacerbation
| ISRCTN | ISRCTN80279999 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN80279999 |
| Protocol serial number | EAME06NIV01 |
| Sponsor | Respironics International, Inc. (France) |
| Funder | Respironics International, Inc. (France) |
- Submission date
- 15/09/2008
- Registration date
- 11/12/2008
- Last edited
- 11/12/2008
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Respiratory
Plain English summary of protocol
Not provided at time of registration
Contact information
Scientific
Laboratoire Exploration Fonctionnelle Cardio-Respiratoire (EFCR)
RDC Haut
CHU Michallon Nord
BP 217
Cedex 09
Grenoble
38043
France
| JPepin@chu-grenoble.fr |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised, parallel group pilot study |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | |
| Study acronym | AVAPS-COPD |
| Study objectives | Long-term domiciliary non-invasive positive pressure ventilation (NPPV) with average volume assured pressure support (AVAPS) in subjects with chronic obstructive pulmonary disease (COPD) who remain hypercapnic following the application of NPPV for an acute exacerbation will improve daytime partial pressure of carbon dioxide (PCO2) and endothelial dysfunction. |
| Ethics approval(s) | Ethics Committee for Protection of Human Subjects, Grenoble University Hospital (CHU de Grenoble) (ref: CPP08-RESP-1), approval pending as of 11/12/2008. |
| Health condition(s) or problem(s) studied | Chronic obstructive pulmonary disease (COPD) |
| Intervention | Treatment group will receive standard optimal care plus NPPV with AVAPS support, ventilatory support function that dynamically determines the pressure support level, which generates the target or control level of exhaled tidal volume by producing a gradual pressure change based on the preceding several breaths. Control group will receive standard optimised care. Total duration of interventions/follow-up: 1 year |
| Intervention type | Other |
| Primary outcome measure(s) |
1. Daytime PCO2, measured by arterial blood gases at baseline, 1, 3, 6 months and 1 year |
| Key secondary outcome measure(s) |
1. Lung function, measured by spirometry, according to the joint recommendations of the ERS/ATS. Timepoints of assessment: baseline, 1, 3, 6 months and 1 year |
| Completion date | 01/11/2010 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | All |
| Target sample size at registration | 60 |
| Key inclusion criteria | 1. Both males and females, aged 50 - 80 years 2. Confirmed diagnosis of COPD according to the joint recommendations of the European Respiratory Society/American Thoracic Society (ERS/ATS) 3. Minimum of 48 hours without NPPV after using NPPV or invasive ventilation in hospital during an acute exacerbation of COPD 4. Persistent hypercapnia (partial pressure of carbon dioxide in the arterial blood [PaCO2] greater than or equal to 50 mmHg, but less than 65 mmHg with an arterial pH above 7.32) during room air spontaneous breathing 5. Able to follow instructions 6. Able to provide informed consent |
| Key exclusion criteria | 1. Actively smoking 2. Therapy with systemic steroids 3. Important concomitant chronic systemic diseases (i.e. chronic heart failure [left ventricular ejection fraction less than 45%], diabetes, infections, neoplasm, forms of sleep disordered breathing, etc) 4. Other chronic respiratory diseases (e.g., significant fibrothorax, bronchiectasis, cystic fibrosis) |
| Date of first enrolment | 01/11/2008 |
| Date of final enrolment | 01/11/2010 |
Locations
Countries of recruitment
- France
Study participating centre
38043
France
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? |
|---|---|---|---|---|---|
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |