Comparison of the effects of spontaneous breathing trial with T-piece versus pressure-support ventilation in patients recovering from cardiac surgery: a randomised controlled pilot study
| ISRCTN | ISRCTN53959736 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN53959736 |
| Protocol serial number | N0205182184 |
| Sponsor | Record Provided by the NHSTCT Register - 2007 Update - Department of Health |
| Funders | Barts and The London NHS Trust (UK), NHS R & D Support Funding (UK) |
- Submission date
- 28/09/2007
- Registration date
- 28/09/2007
- Last edited
- 10/11/2011
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Surgery
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Ms Lee Moi Hew
Scientific
Scientific
ITU
London Chest Hospital
Bonner Road
London
E2 9JX
United Kingdom
| Phone | +44 (0)20 8983 2209 |
|---|---|
| leemoi.hew@bartsandthelondon.nhs.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled pilot study |
| Secondary study design | Randomised controlled trial |
| Scientific title | |
| Study objectives | To compare the mean levels of anxiety reported by two groups of patients using a Visual Analogue Scale (VAS) at specific time points during spontaneous breathing trials with: 1. The T-piece method, or 2. Pressure-support ventilation (PSV) of 10 cm H2O with positive end expiratory pressure (PEEP) 5 cm H2O |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Spontaneous breathing after ventilation |
| Intervention | Patients are randomised to: 1. The T-piece method 2. Pressure-support ventilation (PSV) of 10 cm H2O with positive end expiratory pressure (PEEP) 5 cm H2O |
| Intervention type | Procedure/Surgery |
| Primary outcome measure(s) |
Anxiety scores before operation, at PSV of 10 cm H2O with PEEP of 5 cm H2O, 30-minute after PSV of 10 cm H2O with PEEP of 5 cm H2O, before extubation, one hour after extubation and before discharge from ICU. |
| Key secondary outcome measure(s) |
No secondary outcome measures |
| Completion date | 30/09/2006 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Target sample size at registration | 45 |
| Key inclusion criteria | Not provided at time of registration |
| Key exclusion criteria | Not provided at time of registration |
| Date of first enrolment | 22/03/2006 |
| Date of final enrolment | 30/09/2006 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
ITU
London
E2 9JX
United Kingdom
E2 9JX
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 |
