Condition category
Nutritional, Metabolic, Endocrine
Date applied
30/09/2005
Date assigned
30/09/2005
Last edited
12/12/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr JM Woodward

ORCID ID

Contact details

Anatomy
Selly Oak Hospital
Birmingham
B29 6JD
United Kingdom

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 (0)20 7307 2622
dhmail@doh.gsi.org.uk

Sponsor type

Government

Website

http://www.dh.gov.uk/Home/fs/en

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

Publication citations

Additional files

Editorial Notes