Is looped nasogastric tube feeding more effective than conventional nasogastric tube feeding in dysphagia after acute stroke?

ISRCTN	ISRCTN61174381
DOI	https://doi.org/10.1186/ISRCTN61174381
Protocol serial number	9.0
Sponsor	University of Nottingham (UK)
Funders	Royal College of Physicians (UK), Dunhill Medical Trust Fellowship (UK)

Submission date: 05/04/2006
Registration date: 13/04/2006
Last edited: 30/07/2010

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Circulatory System

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Simon Conroy
Scientific

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

Phone	+44 (0)116 252 5878
Email	spc3@le.ac.uk

Study information

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Scientific title
Study objectives	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(s)	Ethics approval received from the Nottingham Research Ethics Committee 2 on the 22nd August 2006 (ref: 06/Q2404/60).
Health condition(s) or problem(s) studied	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 manufacturers 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
Primary outcome measure(s)	Percentage of nutritional prescription received (amount delivered/amount intended as per dieticians 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.
Key secondary outcome measure(s)	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
Completion date	01/05/2008

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	110
Key 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.
Key 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)
Date of first enrolment	01/06/2006
Date of final enrolment	01/05/2008

Locations

Countries of recruitment

United Kingdom
England

Study participating centre

Senior Lecturer/Geriatrician

Leicester
LE1 9HN
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/09/2010		Yes	No
Protocol article	protocol	03/08/2007		Yes	No