A study of the clinical application of a fixation device for nasogastric and nasoenteral feeding tubes
| ISRCTN | ISRCTN47267595 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN47267595 |
| Secondary identifying numbers | N0265006713 |
- Submission date
- 30/09/2005
- Registration date
- 30/09/2005
- Last edited
- 12/12/2014
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nutritional, Metabolic, Endocrine
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
Dr JM Woodward
Scientific
Scientific
Anatomy
Selly Oak Hospital
Birmingham
B29 6JD
United Kingdom
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Scientific title | A study of the clinical application of a fixation device for nasogastric and nasoenteral feeding tubes |
| Study objectives | 1. Is nasogastric tube fixation acceptable in this country to patients, their relatives, nursing and medical staff? 2. Does nasogastric tube fixation improve nutrient delivery? 3. Does nasogastric tube fixation reduce the number of invasive procedures undergone by patients (nasogastric tube insertions, gastrostomy placement referrals, parenteral feeding referrals)? 4. Is there any difference in clinical outcome between patients that have nasogastric tube fixation and those that do not? |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Nutritional, Metabolic, Endocrine |
| Intervention | Any patient that requires nasogastric tube feeding that has had the tube removed or displaced accidentally on one occasion will be referred to the investigators. The patients will be randomised by assigning alternate patients to current practice (repeated attempts at nasogastric tube placement, referral for alternative routes of feeding, etc) or to nasogastric tube placement with tape fixation. Only patients in this arm of the study will require consent (specimen form attached) and an information sheet will be left with the patient. In the event of the patient being unable to consent, the procedure will be discussed with the next of kin from whom consent will be obtained. Outcomes will be recorded on an observation sheet attached to the patient's file. Competent patients will be questioned during the trial and after removal of the tube to determine acceptability. The trial will be terminated. |
| Intervention type | Device |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | |
| Primary outcome measure | 1. Duration of nasogastric feeding 2. Number of nasogastric tube insertions attempted 3. Proportion of target feed volume delivered 4. Amount of time without tube in place 5. Acceptability of technique to patients, their relatives and staff 6. Number of referrals made for alternative feeding routes 7. Time to resumption of oral feeding 8. Patient discomfort or nasal discharge |
| Secondary outcome measures | Not provided at time of registration |
| Overall study start date | 01/01/2004 |
| Completion date | 01/01/2007 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Target number of participants | Not provided at time of registration |
| Key inclusion criteria | Not provided at time of registration |
| Key exclusion criteria | Not provided at time of registration |
| Date of first enrolment | 01/01/2004 |
| Date of final enrolment | 01/01/2007 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Selly Oak Hospital
Birmingham
B29 6JD
United Kingdom
B29 6JD
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
University Hospital Birmingham NHS Trust (UK)
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 |
