Gastric Ultrasound to Monitor Gastric Residual Volume (GASTRIPED)

Reliability of Gastric Suctioning Compared to Gastric Ultrasound for Residual Gastric Volume Monitoring in Intensive Care Unit Pediatric Patients

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.

Study Overview

• Status: Completed
• Conditions: Mechanical Ventilation Complication; Enteral Feeding Intolerance
• Intervention / Treatment: Other: Gastric ultrasound

• Study Type: Observational
• Enrollment (Actual): 65

Contacts and Locations

Study Locations

• France
  • Bron, France, 69500
    • Service Anesthésie réanimation - Centre Hospitalier Hôpital Femme Mère Enfant Groupement Hospitalier Est - Hospices Civils de Lyon

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 8 months to 18 years (ADULT, CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

This study will be conducted in pediatric intensive care unit patients

Description

Inclusion Criteria:

• Children hospitalized in intensive care unit, requiring invasive or non-invasive mechanical ventilation for a foreseeable duration > 48 hours.
• Enteral nutrition that has been started for more than 48 hours and less than 7 days.
• Age between 37 weeks of post conceptual age and 18 years.
• Parental consent or consent by the person having parental authority.

Exclusion Criteria:

• Abdominal surgery ≤ 1 year
• History of esophageal, gastric, duodenal, or pancreatic surgery
• Enteral nutrition via jejunostomy or gastrostomy.
• Any situation contraindicating the mobilization of the child in the right lateral decubitus position (uncontrolled hemodynamic instability, unstable neurological injury ...)

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of patients with an empty stomach after aspiration of gastric contents performed for the residual gastric volume monitoring.	Empty stomach is defined as the lack of any gastric content when performing the second gastric ultrasound, after aspiration of gastric contents.	Maximum 1 day (Second gastric ultrasound, performed once aspiration of gastric contents has been achieved)

Collaborators and Investigators

• Sponsor: Hospices Civils de Lyon

Study record dates

Study Major Dates

• Study Start (ACTUAL): May 30, 2020
• Primary Completion (ACTUAL): December 18, 2021
• Study Completion (ACTUAL): December 18, 2021

Study Registration Dates

• First Submitted: October 7, 2019
• First Submitted That Met QC Criteria: October 7, 2019
• First Posted (ACTUAL): October 8, 2019

Study Record Updates

• Last Update Posted (ACTUAL): January 25, 2022
• Last Update Submitted That Met QC Criteria: January 24, 2022
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: 69HCL19_0653

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No