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NCT Number: NCT07312890

Bedside Observation by Clinical Ultrasound for Stomach Expansion

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.

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Key information

Conditions

Enteral Feeding Intolerance

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Gastric ultrasound with measurement of the antral area

Other

Gastric ultrasound with measurement of the antral area

Primary outcomes

  1. 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

Secondary outcomes

  1. Occurrence of VAP

    Time frame: From H0 until ICU discharge, up to 3 months

    Occurrence of Ventilator Associated Pneumonia

  2. Mortality

    Time frame: At ICU discharge, at 28 days, and at 3 months

    Mortality at ICU discharge, at day 28, and at 3 months

  3. Duration of mechanical ventilation

    Time frame: From H0 until ICU discharge, up to 3 months

    Number of days on mechanical ventilation

  4. Number of ventilator-free days

    Time frame: Day 28, 3 months

    Number of ventilator-free days at day 28 and 3 months

  5. Length of stay in the ICU

    Time frame: From ICU admission until ICU discharge, up to 3 months

    Length of ICU stay (in days)

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Saint Joseph Saint Luc de Lyon

Other

Registry information

Acronym: BOCUSE

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
Dec 31, 2025
Registry last updated
Dec 31, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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