Study Stopped
Funding withdrawn for the study
The Relative Effectiveness of BOLUS Versus Continuous Nasogastric Feeding After Stroke: a Proof of Principal Study
BOLUS
1 other identifier
interventional
N/A
1 country
1
Brief Summary
Patients with severe strokes are often unable to be take oral diet food and fluids safely because they cannot swallow effectively. Therefore, patients need to be fed via a tube placed through the nose into the stomach (nasogastric tube). Tube feeding can be given by the intermittent (bolus) method, whereby the feed is given over a short time (15 to 30 minutes), or by the continuous feeding method, where the feed is given continuously over 10-16 hours. Nasogastric feeding can be complicated by vomiting or reflux of the feed into the oesophagus causing aspiration of gastric contents into the lung and pneumonia. Nasogastric feeds can be given continuously or as bolus feeds. Healthy people eating normally take their diet in discrete meals. The human digestive system is adapted to intermittent food intake and is likely to work best if food is provided in this pattern, but the larger volume of the feed by this method may cause vomiting and aspiration. It is unclear which method is better for allowing normal digestive processes and reducing pneumonia due to aspirated feeds. There are no trials comparing these two feeding methods in patients with acute stroke. The aim of this small study is to determine if a trial comparing the two treatment approaches is feasible in patients with acute stroke, and to collect information on the effects on feed tolerance and digestion. In this study we will compare the effect of the bolus and intermittent nasogastric tube feeding on digestion and feed tolerance in 20 patients who need nasogastric feeding within 36 hours of a stroke. Patients will be randomly allocated to be given the feeds either by the bolus or by the continuous method for 7 days. During this time they will be examined every day. The study will examine how effectively food is digested by measuring the amount of feed given and the metabolic responses of the body by looking at changes in the level of blood sugar and digestive hormones. The investigators will also monitor complications such as vomiting, diarrhoea, and pneumonia. Patients will be randomly allocated to be given the feeds either by the bolus or by the continuous method for 7 days. This will provide information which will allow the investigators to design a larger definitive study to conclusively prove which method is more appropriate.
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Started Jul 2022
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 12, 2019
CompletedFirst Posted
Study publicly available on registry
July 8, 2019
CompletedStudy Start
First participant enrolled
July 1, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2023
CompletedMay 26, 2022
May 1, 2022
1.1 years
March 12, 2019
May 19, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
Feed tolerance
Total of 7 points. 7/7 full tolerance, 0/7 severe intolerance. This is based on Nutrition, Vomiting, Diarrhoea, Bloating, Abdominal pain, Pneumonia and raised inflammatory markers
7 days
Secondary Outcomes (15)
Number of glucose excursions above 7mmol/L
7 days
mean glucose levels
7 days
glucose centiles
7 days
total area under curve (AUC)
7 days
diurnal AUC
7 days
- +10 more secondary outcomes
Study Arms (2)
Intervention
ACTIVE COMPARATORbolus NGT feeding
Control
OTHERContinuous NGT feeding (standard care)
Interventions
Participants randomised to bolus NGT feeding will receive this for 7 days at mealtimes
Participants randomised to bolus NGT feeding will receive this continuously for 7 days as per hospital protocol
Both participant groups will have continuous glucose monitoring performed for 5 days while in the study
Bloods will be taken to assess all patients metabolic profile
A chest X-ray will be performed on patients receiving study interventions on day 7 to confirm/exclude pneumonia
Eligibility Criteria
You may qualify if:
- Age \>=18 years
- Within 36 h hospital admission with acute ischaemic or haemorrhagic stroke
- Dysphagia requiring nasogastric tube (NGT) feeding (assessed by failed sip test)
You may not qualify if:
- Moribund, receiving palliative care
- Clinical diagnosis of pneumonia
- Pre-existing gastric motility problems
- Inability to obtain consent from the patients or their representative
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University Hospitals of North Midlands NHS Trust
Stoke-on-Trent, Staffordshire, ST4 6QG, United Kingdom
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Fahmy Hanna
Consultant
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 12, 2019
First Posted
July 8, 2019
Study Start
July 1, 2022
Primary Completion
August 1, 2023
Study Completion
September 1, 2023
Last Updated
May 26, 2022
Record last verified: 2022-05
Data Sharing
- IPD Sharing
- Will not share
The participants' clinicians clinical team and members of the research team on the delegation log will access the data. Representatives of the sponsor (UHNM) and representatives the regulatory authorities will have access to personal data for monitoring and audit purposes only.