Enteral Feeding IntoleranceBOCUSENCT07312890
Bedside Observation by Clinical Ultrasound for Stomach Expansion
A study testing Gastric ultrasound with measurement of the antral area in people with Enteral Feeding Intolerance, run by Centre Hospitalier Saint Joseph Saint Luc de Lyon at 1 site in France.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Enteral Feeding Intolerance
- What is being tested?
- Gastric ultrasound with measurement of the antral area
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteFrance
- Study dates
- 25 Oct 2025to 25 Jan 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- No ultrasound window available
- Legally protected adults (under curatorship, guardianship, or judicial protection)
- No social security coverage
- Patient under State Medical Aid (AME)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Hôpital Saint Joseph Saint Luc
Lyon, 69007
Emmanuel Vivier, Dr, +33478618209, evivier@saintjosephsaintluc.fr
Fanny Doroszewski, +33478618398, fdoroszewski@saintjosephsaintluc.fr
About this study
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.
- Conditions
- Enteral Feeding Intolerance
- Being tested
- Gastric ultrasound with measurement of the antral area
- Keywords
- Enteral feeding intolerance, Gastric antral area
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gastric ultrasound with measurement of the antral areaOther
Gastric ultrasound with measurement of the antral area
| Study group | Role | What they receive |
|---|---|---|
| Monitoring of enteral nutrition intolerance | Other | 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 Receives: Other: Gastric ultrasound with measurement of the antral area |
What is being measured
The primary outcome is the main question the study is designed to answer.
Enteral nutrition intolerance
Presence of regurgitation and/or vomiting and/or interruption or reduction of enteral nutrition flow rates
Measured: Within 7 days following the gastric ultrasound
Secondary outcomes (5)
Occurrence of VAP
Occurrence of Ventilator Associated Pneumonia
Measured: From H0 until ICU discharge, up to 3 months
Mortality
Mortality at ICU discharge, at day 28, and at 3 months
Measured: At ICU discharge, at 28 days, and at 3 months
Duration of mechanical ventilation
Number of days on mechanical ventilation
Measured: From H0 until ICU discharge, up to 3 months
Number of ventilator-free days
Number of ventilator-free days at day 28 and 3 months
Measured: Day 28, 3 months
Length of stay in the ICU
Length of ICU stay (in days)
Measured: From ICU admission until ICU discharge, up to 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Dec 2025
- Study start25 Oct 2025
- Primary completion1 Nov 2026 (estimated)
- Study completion25 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Enteral Feeding IntoleranceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Saint Joseph Saint Luc de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07312890
- Sponsor's protocol ID
- BOCUSE
- Acronym
- BOCUSE
- Status last verified
- Dec 2025
- First submitted
- 3 Dec 2025
- Last updated
- 31 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bedside Observation by Clinical Ultrasound for Stomach Expansion
- ClinicalTrials.gov ID
- NCT07312890
- Acronym / sponsor ID
- BOCUSE / BOCUSE
- Conditions
- Enteral Feeding Intolerance
- Keywords
- Enteral feeding intolerance, Gastric antral area
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Centre Hospitalier Saint Joseph Saint Luc de LyonUniversity, hospital or other
- Study start
- 25 Oct 2025 (actual)
- Primary completion
- 1 Nov 2026 (estimated)
- Study completion
- 25 Jan 2027 (estimated)
- First posted
- 31 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Monitoring of enteral nutrition intolerance | Other | Other: Gastric ultrasound with measurement of the antral areaMonitoring 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Gastric ultrasound with measurement of the antral areaGastric ultrasound with measurement of the antral area | Other | Monitoring of enteral nutrition intolerance |
Primary outcome
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
5 secondary outcomes
Occurrence of VAP
Time frame: From H0 until ICU discharge, up to 3 months
Mortality
Time frame: 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 ventilator-free days
Time frame: Day 28, 3 months
Length of stay in the ICU
Time frame: From ICU admission until ICU discharge, up to 3 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Dec 2025.
- Individual participant dataSharing planned: No
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Not yet recruitingObservational study
FACTORS AFFECTİNG ENTERAL FEEDİNG INTOLERANCE İN INTENSİVE CARE UNİT PATİENTS
Patients Who Receive Enteral Nutrition for at Least 72 Hours in the Intensive Care Unit Will be Included in the Study
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Effect of Blenderized Enteral Tube Feeds on Pediatric Upper Gastrointestinal Tract Physiology
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Continuous Versus Intermittent Enteral Feeding and Gastric Residual Volume in Critically Ill Patients
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Not yet recruitingObservational study
Gut Microbiota Structure, Functional and Metabolic Profiles, and Composite Biomarkers in ICU Adults With Refractory Enteral Feeding Intolerance
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Gastric ultrasound with measurement of the antral area in people with Enteral Feeding Intolerance, run by Centre Hospitalier Saint Joseph Saint Luc de Lyon at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 31 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Enteral nutrition intolerance (time frame: Within 7 days following the gastric ultrasound). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Dec 2025.