Stroke Circulatory System Stroke
Conditions
Interventions
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
Sponsors
University of Nottingham (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
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.
Exclusion criteria
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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
United Kingdom
Outcome results
None listed