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ISRCTN
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ISRCTN61174381
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ClinicalTrials.gov identifier
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Public title
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Is looped nasogastric tube feeding more effective than conventional nasogastric tube feeding in dysphagia after acute stroke?
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Scientific title
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Acronym
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N/A
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Serial number at source
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9.0
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Study hypothesis
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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?
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Lay summary
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Ethics approval
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Ethics approval received from the Nottingham Research Ethics Committee 2 on the 22nd August 2006 (ref: 06/Q2404/60).
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Study design
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Randomised controlled trial
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Countries of recruitment
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United Kingdom
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Disease/condition/study domain
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Stroke
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Participants - inclusion criteria
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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.
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Participants - exclusion criteria
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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)
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Anticipated start date
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01/06/2006
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Anticipated end date
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01/05/2008
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Status of trial
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Completed |
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Patient information material
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Target number of participants
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110
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Interventions
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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.
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Primary outcome measure(s)
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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.
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Secondary outcome measure(s)
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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
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Sources of funding
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1. Royal College of Physicians (UK)
2. Dunhill Medical Trust Fellowship (UK)
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Trial website
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Publications
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1. 2007 protocol in http://www.ncbi.nlm.nih.gov/pubmed/17683555
2. 2010 results in http://www.ncbi.nlm.nih.gov/pubmed/20667840
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Contact name
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Dr
Simon
Conroy
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Address
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Senior Lecturer/Geriatrician
Department of Medical Education
University of Leicester School of Medicine
Maurice Shock Medical Sciences Building
PO Box 138
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City/town
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Leicester
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Zip/Postcode
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LE1 9HN
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Country
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United Kingdom
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Tel
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+44 (0)116 252 5878
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Fax
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+44 (0)116 252 5847
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Email
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spc3@le.ac.uk
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Sponsor
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University of Nottingham (UK)
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Address
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Research Support and Commercialisation Office
University of Nottingham
University Park
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City/town
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Nottingham
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Zip/Postcode
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NG7 2RD
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Country
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United Kingdom
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Date applied
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05/04/2006
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Last edited
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30/07/2010
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Date ISRCTN assigned
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13/04/2006
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