Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N0265006713
Study information
Scientific title
A study of the clinical application of a fixation device for nasogastric and nasoenteral feeding tubes
Acronym
Study hypothesis
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
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
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 names
Primary outcome measures
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 trial start date
01/01/2004
Overall trial end date
01/01/2007
Reason abandoned
Eligibility
Participant inclusion criteria
Not provided at time of registration
Participant type
Patient
Age group
Not Specified
Gender
Not Specified
Target number of participants
Not provided at time of registration
Participant exclusion criteria
Not provided at time of registration
Recruitment start date
01/01/2004
Recruitment end date
01/01/2007
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Selly Oak Hospital
Birmingham
B29 6JD
United Kingdom
Sponsor information
Organisation
Department of Health
Sponsor details
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 20 7307 2622
dhmail@doh.gsi.org.uk
Sponsor type
Government
Website
Funders
Funder type
Hospital/treatment centre
Funder name
University Hospital Birmingham NHS Trust (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary