Effect of overnight tube feeding on arterial oxygen saturation
| ISRCTN | ISRCTN22107328 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN22107328 |
| Protocol serial number | N0106153167 |
| Sponsor | Department of Health |
| Funder | Gloucestershire R&D Consortium (UK), NHS R&D Support Funding |
- Submission date
- 30/09/2005
- Registration date
- 30/09/2005
- Last edited
- 11/04/2012
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Other
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Dipankar Dutta
Scientific
Scientific
Elderly Care Department
Gloucestershire Royal Hospital
Great Western Road
Gloucester
GL1 3NN
United Kingdom
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | |
| Study objectives | A randomised study to investigate the effect of overnight tube feeding on arterial oxygen saturation. |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Not Applicable |
| Intervention | Group 1: feeding on night one Group 2: feeding on night two |
| Intervention type | Other |
| Primary outcome measure(s) |
Fall in oxygen saturation of 1% or more |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 31/10/2005 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Target sample size at registration | 32 |
| Key inclusion criteria | 32 patients receiving tube feeding: 1. Adult patients above the age of 18 years, no upper age limit 2. Diagnosis of ischaemic or haemorrhagic stroke within the last 18 weeks 3. Patient fed by NG or PEG tube |
| Key exclusion criteria | 1. Patients who are terminally ill 2. Patients already on supplemental oxygen for any reason |
| Date of first enrolment | 14/10/2004 |
| Date of final enrolment | 31/10/2005 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
Elderly Care Department
Gloucester
GL1 3NN
United Kingdom
GL1 3NN
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 | 01/09/2004 | Yes | No | |
| Results article | results | 01/11/2006 | Yes | No | |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
