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The Relative Effectiveness of BOLUS Versus Continuous Nasogastric Feeding After Stroke: a Proof of Principal Study (BOLUS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04011787
Recruitment Status : Not yet recruiting
First Posted : July 8, 2019
Last Update Posted : February 17, 2020
Sponsor:
Information provided by (Responsible Party):
University Hospitals of North Midlands NHS Trust

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.


Condition or disease Intervention/treatment Phase
Stroke Dysphagia Dietary Supplement: bolus NGT feeding Dietary Supplement: Continuous NGT feeding Diagnostic Test: Continuous Glucose Monitoring Diagnostic Test: Metabolic Profile Radiation: Chest X-ray Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: 20 patients will be randomised to two arms with a control group of a further 10 patients
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: The Relative Effectiveness of BOLUS Versus Continuous Nasogastric Feeding After Stroke: a Proof of Principal Study
Estimated Study Start Date : April 1, 2020
Estimated Primary Completion Date : November 2020
Estimated Study Completion Date : December 2020

Arm Intervention/treatment
Active Comparator: Intervention
bolus NGT feeding
Dietary Supplement: bolus NGT feeding
Participants randomised to bolus NGT feeding will receive this for 7 days at mealtimes

Diagnostic Test: Continuous Glucose Monitoring
Both participant groups will have continuous glucose monitoring performed for 5 days while in the study

Diagnostic Test: Metabolic Profile
Bloods will be taken to assess all patients metabolic profile

Radiation: Chest X-ray
A chest X-ray will be performed on patients receiving study interventions on day 7 to confirm/exclude pneumonia

Control
Continuous NGT feeding (standard care)
Dietary Supplement: Continuous NGT feeding
Participants randomised to bolus NGT feeding will receive this continuously for 7 days as per hospital protocol

Diagnostic Test: Metabolic Profile
Bloods will be taken to assess all patients metabolic profile

Radiation: Chest X-ray
A chest X-ray will be performed on patients receiving study interventions on day 7 to confirm/exclude pneumonia




Primary Outcome Measures :
  1. Feed tolerance [ Time Frame: 7 days ]
    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


Secondary Outcome Measures :
  1. Number of glucose excursions above 7mmol/L [ Time Frame: 7 days ]
    Number of glucose excursions above 7mmol/L

  2. mean glucose levels [ Time Frame: 7 days ]
    mean glucose levels

  3. glucose centiles [ Time Frame: 7 days ]
    10th, 25th, 50th, 75th, 90th

  4. total area under curve (AUC) [ Time Frame: 7 days ]
    total area under the curve (AUC) measured in mmol

  5. diurnal AUC [ Time Frame: 7 days ]
    diurnal AUC

  6. nocturnal AUC [ Time Frame: 7 days ]
    nocturnal AUC

  7. average duration of specific glucose readings [ Time Frame: 7 days ]
    e.g. <4-7.9mmol/l, 7-11mmol/l and >11mmol/l

  8. average hourly change [ Time Frame: 7 days ]
    change in glucose levels from one hour to the next

  9. inter-day variability [ Time Frame: 7 days ]
    change in glucose levels between days

  10. largest amplitude of glycaemic excursions [ Time Frame: 7 days ]
    largest rise in glucose levels

  11. mean amplitude of glycaemic excursions [ Time Frame: 7 days ]
    average of glucose levels

  12. postprandial amplitude of glycaemic excursions [ Time Frame: 7 days ]
    glucose changes after meal

  13. the time-averaged mean insulin and glucose responses [ Time Frame: 5 hours ]
    computed as incremental AUCs (above baseline), divided by the time interval (hours)

  14. total glycaemic exposure [ Time Frame: 5 hours ]
    glucose AUC 0-240

  15. the insulinogenic index [ Time Frame: 5 hours ]
    relationship between insulin and glucose levels at 30 minutes



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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)

Exclusion Criteria:

  • Moribund, receiving palliative care
  • Clinical diagnosis of pneumonia
  • Pre-existing gastric motility problems
  • Inability to obtain consent from the patients or their representative

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04011787


Contacts
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Contact: Heather Reidy 01782 675398 heather.reidy@uhnm.nhs.uk
Contact: Jane Copestick 01782 675616 jane.copestick@uhnm.nhs.uk

Locations
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United Kingdom
University Hospitals of North Midlands NHS Trust
Stoke-on-Trent, Staffordshire, United Kingdom, ST4 6QG
Contact: Heather Reidy    01782 675398    heather.reidy@uhnm.nhs.uk   
Contact: Jane Copestick    01782 675616    jane.copestick@uhnm.nhs.uk   
Principal Investigator: Fahmy Hanna         
Sponsors and Collaborators
University Hospitals of North Midlands NHS Trust
Investigators
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Principal Investigator: Fahmy Hanna Consultant
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Responsible Party: University Hospitals of North Midlands NHS Trust
ClinicalTrials.gov Identifier: NCT04011787    
Other Study ID Numbers: 1437
First Posted: July 8, 2019    Key Record Dates
Last Update Posted: February 17, 2020
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: 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.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases