Bedside Observation by Clinical Ultrasound for Stomach Expansion (BOCUSE)

December 17, 2025 updated by: Centre Hospitalier Saint Joseph Saint Luc de Lyon
The objective of the BOCUSE study is to demonstrate a relationship between an early ultrasound measurement of the gastric antral area and the subsequent occurrence of poor gastric tolerance.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

150

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Age ≥ 18 years
  • Predicted mechanical ventilation ≥ 48 hours
  • Initiation of enteral nutrition via nasogastric or orogastric tube for ≥ 48 hours
  • Free and informed consent obtained from the patient's relative or legal representative, or inclusion in an emergency situation

Exclusion Criteria:

  • History of major gastric surgery (bypass, total gastrectomy, biliopancreatic diversion)
  • Enteral nutrition via nasogastric or orogastric tube > 96 hours
  • Initiation of enteral nutrition before intubation
  • Feeding via gastrostomy, jejunostomy, or jejunal tube
  • Pregnancy
  • Prognosis considered terminal
  • No ultrasound window available
  • Legally protected adults (under curatorship, guardianship, or judicial protection)
  • No social security coverage
  • Patient under State Medical Aid (AME)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Monitoring of enteral nutrition intolerance
Monitoring of enteral nutrition intolerance : presence of regurgitation or vomiting, and interruption or reduction of enteral nutrition flow rates over a 7-day period. Gastric ultrasound with measurement of the antral area
Other: Gastric ultrasound with measurement of the antral area
Gastric ultrasound with measurement of the antral area

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Enteral nutrition intolerance
Time Frame: Within 7 days following the gastric ultrasound
Presence of regurgitation and/or vomiting and/or interruption or reduction of enteral nutrition flow rates
Within 7 days following the gastric ultrasound

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Occurrence of VAP
Time Frame: From H0 until ICU discharge, up to 3 months
Occurrence of Ventilator Associated Pneumonia
From H0 until ICU discharge, up to 3 months
Mortality
Time Frame: At ICU discharge, at 28 days, and at 3 months
Mortality at ICU discharge, at day 28, and at 3 months
At ICU discharge, at 28 days, and at 3 months
Duration of mechanical ventilation
Time Frame: From H0 until ICU discharge, up to 3 months
Number of days on mechanical ventilation
From H0 until ICU discharge, up to 3 months
Number of ventilator-free days
Time Frame: Day 28, 3 months
Number of ventilator-free days at day 28 and 3 months
Day 28, 3 months
Length of stay in the ICU
Time Frame: From ICU admission until ICU discharge, up to 3 months
Length of ICU stay (in days)
From ICU admission until ICU discharge, up to 3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Saint Joseph Saint Luc de Lyon

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 25, 2025

Primary Completion (Estimated)

November 1, 2026

Study Completion (Estimated)

January 25, 2027

Study Registration Dates

First Submitted

December 3, 2025

First Submitted That Met QC Criteria

December 17, 2025

First Posted (Actual)

December 31, 2025

Study Record Updates

Last Update Posted (Actual)

December 31, 2025

Last Update Submitted That Met QC Criteria

December 17, 2025

Last Verified

December 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • BOCUSE

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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