Menu
Recruiting NCT07312890

Bedside Observation by Clinical Ultrasound for Stomach Expansion

No phase Interventional Enteral Feeding Intolerance

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Gastric ultrasound with measurement of the antral area.
Who it may be relevant to
Registry conditions: Enteral Feeding Intolerance. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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

  • Other Gastric ultrasound with measurement of the antral area
    Gastric ultrasound with measurement of the antral area

Primary outcome measures

  • Enteral nutrition intolerance [Time frame: Within 7 days following the gastric ultrasound]
Secondary outcome measures (5)
  • 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]

Eligibility criteria

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)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Prevention

Study locations

France · 1 center
  • Hôpital Saint Joseph Saint Luc — Lyon

Identifiers

NCT: NCT07312890 · BOCUSE

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗