GASTRIPED: Gastric Ultrasound to Monitor Gastric Residual Volume

Sponsor
Hospices Civils de Lyon (Other)
Overall Status
Completed
CT.gov ID
NCT04119089
Collaborator
(none)
65
1
18.6
3.5

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Gastric ultrasound

Study Design

Study Type:
Observational
Actual Enrollment :
65 participants
Observational Model:
Case-Only
Time Perspective:
Prospective
Official Title:
Reliability of Gastric Suctioning Compared to Gastric Ultrasound for Residual Gastric Volume Monitoring in Intensive Care Unit Pediatric Patients
Actual Study Start Date :
May 30, 2020
Actual Primary Completion Date :
Dec 18, 2021
Actual Study Completion Date :
Dec 18, 2021

Outcome Measures

Primary Outcome Measures

  1. Percentage of patients with an empty stomach after aspiration of gastric contents performed for the residual gastric volume monitoring. [Maximum 1 day (Second gastric ultrasound, performed once aspiration of gastric contents has been achieved)]

    Empty stomach is defined as the lack of any gastric content when performing the second gastric ultrasound, after aspiration of gastric contents.

Eligibility Criteria

Criteria

Ages Eligible for Study:
37 Weeks to 18 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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 ...)

Contacts and Locations

Locations

Site City State Country Postal Code
1 Service Anesthésie réanimation - Centre Hospitalier Hôpital Femme Mère Enfant Groupement Hospitalier Est - Hospices Civils de Lyon Bron France 69500

Sponsors and Collaborators

  • Hospices Civils de Lyon

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Hospices Civils de Lyon
ClinicalTrials.gov Identifier:
NCT04119089
Other Study ID Numbers:
  • 69HCL19_0653
First Posted:
Oct 8, 2019
Last Update Posted:
Jan 25, 2022
Last Verified:
Jan 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Jan 25, 2022