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A complex neurohumoral feedback mechanism regulates gastric emptying of enteral nutrition through changes in gastric motility. In this investigation, we aim to investigate the impact of different infusion rates of enteral nutrition on gastric motility, gastric emptying rate, epigastric symptoms and satiation.
Additionally, magnetic resonance imaging will be used to validate an extended 13C-octanoate breath test for gastric emptying of a liquid test meal that is infused over 2 hours. Furthermore, the reliability of a manual position check of the VIPUN Balloon catheter will be confirmed with radiographic imaging. Finally, the data will be used for the data driven optimization of the VIPUN MI algorithm.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Condition A | Experimental |
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| Condition B | Experimental |
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| Condition C | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| VIPUN Balloon Catheter | Device | The VIPUN Balloon Catheter is a nasogastric balloon catheter consisting of a standard nasogastric double lumen Sump catheter and a balloon attached to this catheter. Once the catheter is advanced into the stomach, the balloon can be inflated. The inflated balloon dimensions and intraballoon pressure are such that intragastric motility can optimally be assessed without inducing epigastric symptoms. |
| Measure | Description | Time Frame |
|---|---|---|
| Motility | Motility index (MI) measured with the VIPUN Balloon Catheter. | 8 hour |
| Gastric emptying rate (13C-Octanoate Breath Test) | Gastric emptying rate of liquid test meal, measured with 13C-Octanoate Breath Test. | 8 hour |
| Gastric emptying rate (Magnetic resonance imaging) | Gastric emptying rate of liquid test meal, measured with magnetic resonance imaging | Conditions B and C: 4 hour. |
| Measure | Description | Time Frame |
|---|---|---|
| Satiation | Subjective satiation score at a 30-minute interval. Visual Analogue Scale (100 mm, 0=absent, 100= maximal sensation). | 6 hour |
| Safety profile VIPUN Balloon Catheter | Incidence, frequency, severity, seriousness and relatedness of AE's |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UZ Leuven | Leuven | Vlaams-Brabant | 3000 | Belgium |
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Three-way crossover
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| Trough study completion, from Visit 1 until completion of Visit 3, on average 3 weeks |
| Feasibility VIPUN Balloon Catheter related procedures | Success rate of completing the procedure (placement and removal VIPUN Balloon Catheter | Trough study completion, from Visit 1 until completion of Visit 3, on average 3 weeks |
| Reliability manual position check | Success rate (pass/fail) (reliability) of the manual position check of the VIPUN balloon catheter | Once for each subject (during Condition A only): Position of the inflated balloon is judged on the thorax Rx (t<0) prior to start motility recording (= reference time point, t=0). |
| Position catheter at t=480. | Qualitative assessment of the migration of the catheter over the course of the study procedures. | During Condition A only: at t=480 minutes (after cessation motility recording). |
| Epigastric symptoms | Subjective epigastric symptom scores at a 30-minute interval. 3 Visual Analogue Scales (100 mm, 0=absent, 100= maximal sensation). Scale 1: Nausea, Scale 2: Bloating, Scale 3: Pain. | 6 hours |