Bedside ultrasound measurement of the stomach antral area to predict enteral feeding intolerance
Bedside Observation by Clinical Ultrasound for Stomach Expansion
This test uses an early bedside ultrasound of the stomach's antral area to see if it can predict which ventilated adult patients on tube feeding will later have poor gastric tolerance.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 150 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Centre Hospitalier Saint Joseph Saint Luc de Lyon Academic / other |
| Locations | 1 site (Lyon) |
| Trial ID | NCT07312890 on ClinicalTrials.gov |
What this trial studies
In this single-center interventional protocol, clinicians perform a bedside gastric ultrasound to measure the antral cross-sectional area early after enteral nutrition is started. Measured antral area values are compared with subsequent clinical signs of poor gastric tolerance (for example high gastric residuals, vomiting, or need to stop/reduce feeding). The study enrolls adults expected to remain on mechanical ventilation for at least 48 hours and receiving enteral feeding via a nasogastric or orogastric tube within a defined early window. The aim is to determine whether that early ultrasound measurement predicts later feeding intolerance.
Who should consider this trial
Good fit: Ideal candidates are adults (≥18) in the ICU who are predicted to need mechanical ventilation ≥48 hours and who have been started on enteral nutrition via a nasogastric or orogastric tube within the early 48–96 hour window.
Not a fit: Patients unlikely to benefit include those with prior major gastric surgery, those fed by gastrostomy/jejunostomy or jejunal tube, pregnant patients, patients with no ultrasound window, terminal prognosis, or those excluded for legal/social coverage reasons.
Why it matters
Potential benefit: If successful, this approach could help clinicians identify patients at high risk for feeding intolerance sooner and adapt feeding strategies to reduce complications.
How similar studies have performed: Prior studies using gastric ultrasound have shown good correlation between antral area and gastric volume or aspiration risk, but using an early antral-area measurement specifically to predict later enteral feeding intolerance is relatively novel and not yet widely proven.
Eligibility criteria
Show full inclusion / exclusion 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)
Where this trial is running
Lyon
- Hôpital Saint Joseph Saint Luc — Lyon, France (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.