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Bedside Observation by Clinical Ultrasound for Stomach Expansion

Bedside Observation by Clinical Ultrasound for Stomach Expansion

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07312890
Acronym
BOCUSE
Enrollment
150
Registered
2025-12-31
Start date
2025-10-25
Completion date
2027-01-25
Last updated
2025-12-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Enteral Feeding Intolerance

Keywords

Enteral feeding intolerance, Gastric antral area

Brief 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.

Interventions

OTHERGastric ultrasound with measurement of the antral area

Gastric ultrasound with measurement of the antral area

Sponsors

Centre Hospitalier Saint Joseph Saint Luc de Lyon
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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)

Design outcomes

Primary

MeasureTime frameDescription
Enteral nutrition intoleranceWithin 7 days following the gastric ultrasoundPresence of regurgitation and/or vomiting and/or interruption or reduction of enteral nutrition flow rates

Secondary

MeasureTime frameDescription
Occurrence of VAPFrom H0 until ICU discharge, up to 3 monthsOccurrence of Ventilator Associated Pneumonia
MortalityAt ICU discharge, at 28 days, and at 3 monthsMortality at ICU discharge, at day 28, and at 3 months
Duration of mechanical ventilationFrom H0 until ICU discharge, up to 3 monthsNumber of days on mechanical ventilation
Number of ventilator-free daysDay 28, 3 monthsNumber of ventilator-free days at day 28 and 3 months
Length of stay in the ICUFrom ICU admission until ICU discharge, up to 3 monthsLength of ICU stay (in days)

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026