A trial of withdrawal of nocturnal non-invasive positive pressure ventilation (NIPPV) in chronic obstructive pulmonary disease (COPD) patients with chronic hypercapnic ventilatory failure previously stable on nocturnal NIPPV
| ISRCTN | ISRCTN00075564 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN00075564 |
| Secondary identifying numbers | 04/Q0104/139 - NRR Publication ID: N0542155456 |
- Submission date
- 23/05/2005
- Registration date
- 08/07/2005
- Last edited
- 16/07/2010
- 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 NHS Trust
Papworth Everard
Cambridge
CB3 8RE
United Kingdom
| Phone | +44 (0)1480 830541 |
|---|
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Treatment |
| Scientific title | |
| Study objectives | Currently it is unclear whether patients with severe COPD benefit from noninvasive positive pressure ventilation in the long term. There is divided opinion and evidence on whether this is a beneficial treatment and who might benefit. In performing this clinical trial of withdrawal of a non-proven treatment with close monitoring we plan to address the issue of whether of not the treatment does maintain the patients in a stable clinical state and improve their quality of life. |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Chronic Obstructive Pulmonary Disease (COPD) |
| Intervention | Comparison of withdrawing long term NIPPV treatment or continuing |
| Intervention type | Other |
| Primary outcome measure | 'Withdrawal Failure' as stipulated by preset criteria. The effect of withdrawal of NIPPV therapy on arterial blood gas analysis. Criteria for Withdrawal Failure: 1. Daytime PaCO2 >9 kPa 2. Nocturnal PtcCO2 >10 on night study 3. Respiratory acidosis pH <7.35 4. Intolerable symptoms, including morning headache and drowsiness |
| Secondary outcome measures | 1. Assess the effect of withdrawal of NIPPV therapy on: quality of life using SF-36 and St George's respiratory questionnaire, exacerbation rates, hospital admissions, GP contact and requirements for treatment with antibiotics and steroids 2. Assess that if preset criteria are met, reinstitution of NIPPV therapy has positive effects 3. Measure changes to spirometric, mouth pressure data and exercise capacity |
| Overall study start date | 16/05/2005 |
| Completion date | 31/01/2007 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 40 |
| Key inclusion criteria | Pre-screening criteria: 1. Diagnosis of COPD: forced expiratory volume in 1 second (FEV1) <50% predicted, FEV1/forced vital capacity (FVC) ratio <70%, total lung capacity (TLC) >80% predicted 2. Smoking history >20 pack years 3. Prior to commencing NIPPV hypercapnic ventilatory failure with daytime PaCO2 >7.5 kPa with normal pH (7.35-7.45) or nocturnal PtcCO2 >9 kPa 4. On NIPPV for at least 3 months with compliance of >4 hours/day 5. Live within 40-mile radius of trust Screening criteria: 1. Clinically stable - no increase in breathlessness, cough or sputum volume in 4 weeks between initial assessment and entry to trial 2. PaCO2 within +/-1 kPa of initial assessment 3. No change in spirometry (<15% or 200 ml) from initial assessment |
| Key exclusion criteria | 1. Age over 80 2. Other significant respiratory disease (interstitial lung disease, asthma, bronchiectasis, neuromuscular or restrictive chest wall disorders) 3. Significant documented left ventricular dysfunction with Ejection Fraction <40% 4. Obstructive sleep apnoea with an apnoea/hypopnoea index of over 10, which is reversible by continuous positive airway pressure (CPAP) |
| Date of first enrolment | 16/05/2005 |
| Date of final enrolment | 31/01/2007 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Papworth Hospital NHS Trust
Cambridge
CB3 8RE
United Kingdom
CB3 8RE
United Kingdom
Sponsor information
Papworth Hospital NHS Trust (UK)
Hospital/treatment centre
Hospital/treatment centre
Papworth Everard
Cambridge
CB3 8RE
England
United Kingdom
| Phone | +44 (0)1480 830541 |
|---|---|
| diane.bilton@papworth.nhs.uk | |
"ROR" |
https://ror.org/01qbebb31 |
Funders
Funder type
Industry
Respiratory Support and Sleep Centre Trust fund supported by an unrestricted grant from B & D Electromedical (UK)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | 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 | 01/04/2010 | Yes | No |
