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

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.

Conditions

• Stroke
• Dysphagia

Interventions

DIETARY_SUPPLEMENT

bolus NGT feeding

Participants randomised to bolus NGT feeding will receive this for 7 days at mealtimes

DIETARY_SUPPLEMENT

Continuous NGT feeding

Participants randomised to bolus NGT feeding will receive this continuously for 7 days as per hospital protocol

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

Sponsors & Collaborators

• University Hospitals of North Midlands NHS Trust

  lead OTHER

Principal Investigators

• Fahmy Hanna · Consultant

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2022-07-01

Primary Completion

2023-08-31

Completion

2023-09-30

Countries

• United Kingdom

Study Locations