NCT04119089: GASTRIPED

Gastric Ultrasound to Monitor Gastric Residual Volume

Completed Last updated 25 January 2022

What this trial tests

trial testing Gastric ultrasound in Mechanical Ventilation Complication in 65 participants. Completed in 18 December 2021.

Timeline

30 May 2020

Primary endpoint
18 December 2021

18 December 2021

Quick facts

Lead sponsor	Hospices Civils de Lyon
Status	Completed
Study type	OBSERVATIONAL
Enrollment	65
Start date	30 May 2020
Primary completion	18 December 2021
Estimated completion	18 December 2021
Sites	1 location across France

Drugs / interventions tested

• Gastric ultrasound

Conditions studied

• Mechanical Ventilation Complication — all drugs for Mechanical Ventilation Complication →
• Enteral Feeding Intolerance — all drugs for Enteral Feeding Intolerance →

Sponsor

Hospices Civils de Lyon — full company profile →

Who can join

Adults 37 Weeks to 18, any sex, with Mechanical Ventilation Complication or Enteral Feeding Intolerance. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

It is currently recommended to start enteral nutrition early in intensive care unit children receiving invasive or non-invasive mechanical ventilation.

Gastrointestinal intolerance is the main complication related to early enteral feeding in intensive care unit patients, characterized by gastroparesis with delayed gastric emptying that may lead to regurgitations, vomiting, pulmonary aspiration, and potentially increased risk of ventilator-associated pneumonia (VAP).

Residual gastric volume (RGV) measurement had been recommended to monitor the tolerance to enteral nutrition in mechanically ventilated patients receiving early enteral feeding.

Nevertheless, several studies have challenged the usefulness of such RGV monitoring, showing that it led to reduced caloric intake without any benefits in terms of reducing the occurrence of vomiting and the incidence of VAP.

This lack of relationship between RGV monitored using gastric suctioning and the occurrence of regurgitation, aspiration and pneumonia may reflect the inaccuracy of the aspiration method used for the measurement of the RGV, as it has been reported in adult patients.

Gastric ultrasonography is a non-invasive and easy-to-use tool allowing accurate preoperative assessment of gastric contents, based on both qualitative examination of the gastric antrum and calculation of gastric content volume. Ultrasound examination of the antrum could therefore constitute an alternative to gastric suctioning for the monitoring of RGV in intensive care unit patients.

This prospective study aims to assess the reliability of the RGV monitoring based on gastric suctioning compared to ultrasound technique. Secondary endpoint is to assess whether increased gastric volume, aspirated or calculated by ultrasound, is an independent risk factor of regurgitation and / or vomiting.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Gastric Point-of-Care Ultrasound in Acutely and Critically Ill Children (POCUS-ped): A Scoping Review.
   Valla FV, Tume LN, Jotterand Chaparro C, Arnold P, et al · · 2022 · cited 12× · PMID 35874585 · DOI 10.3389/fped.2022.921863
2. Point-of-Care Gastric Ultrasound Confirms the Inaccuracy of Gastric Residual Volume Measurement by Aspiration in Critically Ill Children: GastriPed Study.
   Valla FV, Cercueil E, Morice C, Tume LN, et al · · 2022 · cited 9× · PMID 35783320 · DOI 10.3389/fped.2022.903944