Effect of mouth leak and humidification on non-invasive pressure support ventilation
| ISRCTN | ISRCTN13563393 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN13563393 |
| Protocol serial number | N0436130418 |
| Sponsor | Department of Health |
| Funders | Leeds Teaching Hospitals NHS Trust (UK), None |
- 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
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| 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(s) |
1. Delivered tidal volume |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 16/10/2003 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Target sample size at registration | 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
- United Kingdom
- England
Study participating centre
Department of Respiratory Medicine (ward 14)
Leeds
LS9 7TF
United Kingdom
LS9 7TF
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 | 01/09/2007 | Yes | No |
