Condition category
Circulatory System
Date applied
05/04/2006
Date assigned
13/04/2006
Last edited
30/07/2010
Prospective/Retrospective
Prospectively 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 Simon Conroy

ORCID ID

Contact details

Senior Lecturer/Geriatrician
Department of Medical Education
University of Leicester School of Medicine
Maurice Shock Medical Sciences Building
PO Box 138
Leicester
LE1 9HN
United Kingdom
+44 (0)116 252 5878
spc3@le.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

9.0

Study information

Scientific title

Acronym

Study hypothesis

Does use of the looped nasogastric tube (LNGT) in dysphagic acute stroke patients result in a greater proportion of nutritional prescription received per patient over a two-week period than conventional nasogastric tube use?

Ethics approval

Ethics approval received from the Nottingham Research Ethics Committee 2 on the 22nd August 2006 (ref: 06/Q2404/60).

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

Stroke

Intervention

Please note that this trial has now closed and analysis is underway. The previous anticipated end date for this trial was 01/12/2008.

Interventions:
The intervention group will receive all usual care except that the looped nasogastric feeding tube will be used for feed delivery. Subjects will have the loop component of the LNGT sited as per manufacturer’s instructions. The loop will be sited by either the research fellow, stroke nurses or ward staff who will have been fully trained in placing the loop. A nasogastric tube (NGT) will be passed and once in place fixed using the loop, thus creating the looped nasogastric tube. Upon confirmation that the NGT is correctly located, feeding will be commenced on an incremental fashion as per local protocols, which will vary between the centres.

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

Percentage of nutritional prescription received (amount delivered/amount intended as per dietician’s prescription, including all feed and fluids) delivered in the two weeks from allocation or at the point NG feeding is stopped earlier on clinical grounds.

Secondary outcome measures

1. Number of times tube re-sited in two weeks; treatment failure/completed treatment as specified (where treatment failure means any occasion where attempts at nasogastric tube feeding is ceased before normal oral intake is established, and includes multiple failed attempts at passing a tube, use of a percutaneous endoscopic gastrostomy (PEG) (in first two weeks), death or deterioration such that feeding is considered unsafe or unwanted)
2. Mean volume of nasogastric feed delivered in the two weeks from allocation
3. Proportion of patients requiring early PEG insertions
4. The technical efficiency (that is whether the best outcome is being achieved within a given set of resources) of looped nasogastric feeding after stroke compared to ordinary nasogastric tubes will be assessed from an National Health Service (NHS) perspective to see if this new technology offers value for money. An intervention specific outcome will be used to estimate an incremental cost-effectiveness ratio in the form of a cost per change in percentage nutritional prescription received.
5. Change in Demiquet index from baseline to two weeks (weight in kilograms)
6. Tolerability or acceptability of technique by questionnaires to patients, families and nursing staff

Overall trial start date

01/06/2006

Overall trial end date

01/05/2008

Reason abandoned

Eligibility

Participant inclusion criteria

Any adult (>18 years of age) with an acute clinically diagnosed stroke as defined by World Health Organisation (WHO) standards; managed on the stroke unit. A clinical decision to attempt nasogastric tube feeding according to usual protocols has been made by the attending clinical team.

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

110

Participant exclusion criteria

1. Those not consenting to either nasogastric tube (NGT) placement or to entry into the trial
2. Those lacking capacity for whom NG feeding is determined not to be in their best interests
3. Pregnant women
4. Those with contraindications to NG feeding (nasal trauma/malignancies)

Recruitment start date

01/06/2006

Recruitment end date

01/05/2008

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Senior Lecturer/Geriatrician
Leicester
LE1 9HN
United Kingdom

Sponsor information

Organisation

University of Nottingham (UK)

Sponsor details

Research Support and Commercialisation Office
University of Nottingham
University Park
Nottingham
NG7 2RD
United Kingdom

Sponsor type

University/education

Website

Funders

Funder type

Research organisation

Funder name

Royal College of Physicians (UK)

Alternative name(s)

RCP

Funding Body Type

private sector organisation

Funding Body Subtype

professional associations and societies

Location

United Kingdom

Funder name

Dunhill Medical Trust Fellowship (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

1. 2007 protocol in http://www.ncbi.nlm.nih.gov/pubmed/17683555
2. 2010 results in http://www.ncbi.nlm.nih.gov/pubmed/20667840

Publication citations

  1. Protocol

    Beavan JR, Conroy S, Leonardi-Bee J, Bowling T, Gaynor C, Gladman J, Good D, Gorman P, Harwood R, Riley J, Sach T, Sunman W, Is looped nasogastric tube feeding more effective than conventional nasogastric tube feeding for dysphagia in acute stroke?, Trials, 2007, 8, 19, doi: 10.1186/1745-6215-8-19.

  2. Results

    Beavan J, Conroy SP, Harwood R, Gladman JR, Leonardi-Bee J, Sach T, Bowling T, Sunman W, Gaynor C, Does looped nasogastric tube feeding improve nutritional delivery for patients with dysphagia after acute stroke? A randomised controlled trial., Age Ageing, 2010, 39, 5, 624-630, doi: 10.1093/ageing/afq088.

Additional files

Editorial Notes