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
Protocol serial number	N0265006713
Sponsor	Department of Health
Funder	University Hospital Birmingham NHS Trust (UK)

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

Anatomy
Selly Oak Hospital
Birmingham
B29 6JD
United Kingdom

Study information

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
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
Phase	Not Specified
Drug / device / biological / vaccine name(s)
Primary outcome measure(s)	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
Key secondary outcome measure(s)	Not provided at time of registration
Completion date	01/01/2007

Eligibility

Participant type(s)	Patient
Age group	Not Specified
Sex	Not Specified
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

United Kingdom
England

Study participating centre

Selly Oak Hospital

Birmingham
B29 6JD
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