Bedside Observation by Clinical Ultrasound for Stomach Expansion

NCT ID: NCT07312890

Last Updated: 2025-12-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-10-25

Study Completion Date

2027-01-25

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Enteral Feeding Intolerance

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Enteral feeding intolerance Gastric antral area

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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

Group Type OTHER

Gastric ultrasound with measurement of the antral area

Intervention Type OTHER

Gastric ultrasound with measurement of the antral area

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Gastric ultrasound with measurement of the antral area

Gastric ultrasound with measurement of the antral area

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Centre Hospitalier Saint Joseph Saint Luc de Lyon

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Hôpital Saint Joseph Saint Luc

Lyon, , France

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

France

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Emmanuel Vivier, Dr

Role: primary

Fanny Doroszewski

Role: backup

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

BOCUSE

Identifier Type: -

Identifier Source: org_study_id