Bedside Observation by Clinical Ultrasound for Stomach Expansion

NCT07312890 | Recruiting

• 1 other identifier: BOCUSE
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

Enteral Feeding Intolerance

Keywords

Enteral feeding intolerance; Gastric antral area

Outcome Measures

Primary Outcomes (1)

• Enteral nutrition intolerance

  Presence of regurgitation and/or vomiting and/or interruption or reduction of enteral nutrition flow rates

  Within 7 days following the gastric ultrasound

Secondary Outcomes (5)

• Occurrence of VAP

  From H0 until ICU discharge, up to 3 months

• Mortality

  At ICU discharge, at 28 days, and at 3 months

• Duration of mechanical ventilation

  From H0 until ICU discharge, up to 3 months

• Number of ventilator-free days

  Day 28, 3 months

• Length of stay in the ICU

  From ICU admission until ICU discharge, up to 3 months

Study Arms (1)

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

Other: Gastric ultrasound with measurement of the antral area

Interventions

Gastric ultrasound with measurement of the antral area OTHER

Gastric ultrasound with measurement of the antral area

Monitoring of enteral nutrition intolerance

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 years
• Predicted mechanical ventilation ≥ 48 hours
• Initiation of enteral nutrition via nasogastric or orogastric tube for ≥ 48 hours

You may not qualify if:

• 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)

Sponsors & Collaborators

• Centre Hospitalier Saint Joseph Saint Luc de Lyon: lead

Study Sites (1)

Hôpital Saint Joseph Saint Luc

Lyon, 69007, France

RECRUITING

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 3, 2025
• First Posted: December 31, 2025
• Study Start: October 25, 2025
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): January 25, 2027
• Last Updated: December 31, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)