Effect of mouth leak and humidification on non-invasive pressure support ventilation
| ISRCTN | ISRCTN13563393 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN13563393 |
| Secondary identifying numbers | N0436130418 |
- Submission date
- 30/09/2005
- Registration date
- 30/09/2005
- Last edited
- 21/07/2009
- 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 Justin Tuggey
Scientific
Scientific
Department of Respiratory Medicine (ward 14)
Leeds Teaching Hospitals NHS Trust
Beckett Street
Leeds
LS9 7TF
United Kingdom
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Other |
| Study type | Not Specified |
| Scientific title | |
| Study objectives | It will help to determine the appropriate treatment parameter targets and in turn the most appropriate type of ventilator for patients undergoing non-invasive ventilation for chest wall and neuromuscular weakness. In addition it will help understanding the pathogenesis of respiratory failure in such patients |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Respiratory: Non-invasive ventilation |
| Intervention | Randomised controlled trial; Before-after trial Random allocation to [a] treatment a [b] treatment b |
| Intervention type | Other |
| Primary outcome measure | 1. Delivered tidal volume 2. minute ventilation |
| Secondary outcome measures | Not provided at time of registration |
| Overall study start date | 01/06/2002 |
| Completion date | 16/10/2003 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Target number of participants | 70 |
| Key inclusion criteria | Patients will be asked to volunteer for the study from a patient base of approximately 70 patients whom are already established on non-invasive ventilation at home. |
| Key exclusion criteria | 1. Change in ventilator or its settings within last 6 weeks 2. recent deterioration in condition 3. rapidly progressive disease 4. patient refusal |
| Date of first enrolment | 01/06/2002 |
| Date of final enrolment | 16/10/2003 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Department of Respiratory Medicine (ward 14)
Leeds
LS9 7TF
United Kingdom
LS9 7TF
United Kingdom
Sponsor information
Department of Health
Government
Government
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
| Phone | +44 (0)20 7307 2622 |
|---|---|
| dhmail@doh.gsi.org.uk | |
| Website | http://www.dh.gov.uk/Home/fs/en |
Funders
Funder type
Hospital/treatment centre
Leeds Teaching Hospitals NHS Trust (UK)
No information available
None
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 | 01/09/2007 | Yes | No |
