Bedside Observation by Clinical Ultrasound for Stomach Expansion (BOCUSE)

Centre Hospitalier Saint Joseph Saint Luc de Lyon

Status: Enrolling

Conditions: Enteral Feeding Intolerance

Treatments: Other: Gastric ultrasound with measurement of the antral area

Study type: Interventional

Funder types: Other

Identifiers

NCT07312890

BOCUSE

Details and patient eligibility

About

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.

Enrollment: 150 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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150 participants in 1 patient group

Monitoring of enteral nutrition intolerance

Other group

Description:

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

Treatment:

Other: Gastric ultrasound with measurement of the antral area