Randomised trial of outpatient versus inpatient initiation on non-invasive ventilation (NIV) in adults and children with chronic ventilatory failure
| ISRCTN | ISRCTN77271265 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN77271265 |
| Protocol serial number | N0201109246 |
| Sponsor | Department of Health |
| Funder | Royal Brompton and Harefield NHS Trust (UK) |
- Submission date
- 30/09/2004
- Registration date
- 30/09/2004
- Last edited
- 25/10/2011
- 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 Anita K Simonds
Scientific
Scientific
Respiratory Medicine
Royal Brompton & Harefield NHS Trust
Sydney Street
London
SW3 6NP
United Kingdom
| Phone | +44 (0)20 7351 8911 |
|---|---|
| a.simonds@rbh.nthames.nhs.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | |
| Study objectives | Aim is to investigate whether starting NIV as an outpatient is as effective in terms of physiological improvement, tolerance and compliance, as standard inpatient initiation. We will also determine the cost and staffing implications of this change in clinical practice. |
| Ethics approval(s) | Ethics approval was received from the local medical ethics committee before trial recruitment began. |
| Health condition(s) or problem(s) studied | Respiratory: Chronic ventilatory failure |
| Intervention | 24 patients fulfilling entry criteria will be randomised to outpatient or inpatient initiation of NIV using a block randomisation process to ensure balance for diagnosis and age. |
| Intervention type | Other |
| Primary outcome measure(s) |
Not provided at time of registration |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 31/12/2003 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Target sample size at registration | 24 |
| Key inclusion criteria | 24 patients per year. |
| Key exclusion criteria | Not provided at time of registration |
| Date of first enrolment | 13/02/2002 |
| Date of final enrolment | 31/12/2003 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
Respiratory Medicine
London
SW3 6NP
United Kingdom
SW3 6NP
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 | 01/11/2008 | Yes | No |
