|
ISRCTN
|
ISRCTN47267595
|
|
ClinicalTrials.gov identifier
|
|
|
Public title
|
A Study of the Clinical Application of a Fixation Device for Nasogastric and Nasoenteral Feeding Tubes.
|
|
Scientific title
|
|
|
Acronym
|
N/A
|
|
Serial number at source
|
N0265006713
|
|
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
|
|
Countries of recruitment
|
United Kingdom
|
|
Disease/condition/study domain
|
Nutritional, Metabolic, Endocrine
|
|
Participants - inclusion criteria
|
Not provided at time of registration
|
|
Participants - exclusion criteria
|
Not provided at time of registration
|
|
Anticipated start date
|
01/01/2004
|
|
Anticipated end date
|
01/01/2007
|
|
Status of trial
|
Completed
|
|
Patient information material
|
|
|
Target number of participants
|
Not provided at time of registration
|
|
Interventions
|
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.
|
|
Primary outcome measure(s)
|
Outcomes to be monitored will include the following:
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 measure(s)
|
Not provided at time of registration
|
|
Sources of funding
|
University Hospital Birmingham NHS Trust (UK)
|
|
Trial website
|
|
|
Publications
|
|
|
Contact name
|
Dr
JM
Woodward
|
|
Address
|
Anatomy
Selly Oak Hospital
|
|
City/town
|
Birmingham
|
|
Zip/Postcode
|
B29 6JD
|
|
Country
|
United Kingdom
|
|
Sponsor
|
Record Provided by the NHSTCT Register - 2005 Update - Department of Health (UK)
|
|
Address
|
The Department of Health, Richmond House, 79 Whitehall
|
|
City/town
|
London
|
|
Zip/Postcode
|
SW1A 2NL
|
|
Country
|
United Kingdom
|
|
Tel
|
+44 (0)20 7307 2622
|
|
Email
|
dhmail@doh.gsi.org.uk
|
|
Sponsor website:
|
http://www.dh.gov.uk/Home/fs/en
|
|
Date applied
|
30/09/2005
|
|
Last edited
|
02/06/2008
|
|
Date ISRCTN assigned
|
30/09/2005
|
