The established mathematical model for the assessment of gastric volume will prove to be valid for non-clear fluids.
ID
Bron
Verkorte titel
Aandoening
Critically ill
Enteral feeding
Gastric emptying
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
Validate the existing mathematical clear fluid model for gastric volume for non-clear fluids.
Achtergrond van het onderzoek
Introduction
Enteral nutrition management in critically ill patients is essential. Gastric emptying time is delayed in critically ill, mechanically ventilated patients which increases chances of malnutrition, pulmonary aspiration, infections and mortality. Current methods for monitoring enteral feeding are unreliable and result in unnecessary cessations of enteral feedings and suboptimal provision of nutrition.
Bedside gastric ultrasonography (GUS) is a recent non-invasive tool that provides both qualitative and quantitative information about gastric contents. Using a cross-sectional area of the gastric antrum (antral CSA) and a validated mathematical model, it is possible to accurately estimate total gastric clear fluid volumes.
However, this mathematical model has been validated for clear fluids only. The primary aim of this study is to investigate if the existing model can be validated to estimate non-clear fluid volumes.
Secondary objectives of this study include assessment of gastric emptying time and assessment of the previously established 3-point Perlas grading scale.
Methods
Healthy volunteers will be recruited and asked to arrive fasted according to national guidelines. All participants will be scanned in supine and RLD position and gastric volume will be calculated using this previously established mathematical model:
Volume = 27.0 + 14.6 * Right-latCSA – 1.28 * age
After the first ultrasound exam each participant will be asked to drink a bottle of non-clear fluid (Nutricia Nutridrink) with a predetermined volume, to which the examiner is blinded. A second exam, both in supine and RLD position, will be performed 5 minutes post-drink and every 15 minutes until the antrum has returned to pre-ingestion baseline CSA/volume.
Doel van het onderzoek
The established mathematical model for the assessment of gastric volume will prove to be valid for non-clear fluids.
Onderzoeksopzet
The primary and secondary outcomes will be assessed on the day of the ultrasound exam.
Publiek
Wetenschappelijk
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
- Minimal 18 years of age
- American Society of Anesthesiologists (ASA) physical status classification I or II
- Body mass index < 35 kg/m2
- Adhered to national fasting guidelines of 6 hours for food and 2 hours for clear liquids
- Ability to understand the study protocol and provide informed consent
- Baseline gastric antrum grade 0 or 1
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
- Pregnancy, diabetes mellitus type I or II, hiatus hernia, neurological disease. (Gastro-esophageal reflux disease is not an exclusion criterium)
- History of upper gastrointestinal disease or surgical procedures of the esophagus or the upper abdomen
- Baseline gastric antrum grade 2 or with solid food
- Known allergy for any of the ingredients of Nutrison Nutridrink® or galactosemia
Opzet
Deelname
Voornemen beschikbaar stellen Individuele Patiënten Data (IPD)
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In overige registers
| Register | ID |
|---|---|
| NTR-new | NL7677 |
| Ander register | CMO Radboudumc : 2019-5365 |