Actively Recruiting
Bedside Observation by Clinical Ultrasound for Stomach Expansion
Led by Centre Hospitalier Saint Joseph Saint Luc de Lyon · Updated on 2025-12-31
150
Participants Needed
1
Research Sites
12 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to explore the connection between early ultrasound measurements of the stomach's antral area and the development of poor tolerance to enteral feeding among patients expected to need mechanical ventilation for at least 48 hours. The study focuses on adults aged 18 and older who have begun enteral nutrition through nasogastric or orogastric tubes. The goal is to better predict and understand feeding intolerance in critical care settings. Participants will undergo bedside gastric ultrasound to measure the antral area. Over the following seven days, researchers will monitor signs of enteral nutrition intolerance, such as regurgitation, vomiting, and any interruptions or reductions in feeding flow rates. This period includes continuous observation to assess how stomach expansion relates to feeding tolerance. The study does not involve any masking or placebo control. During participation, patients will be regularly assessed for feeding intolerance and monitored for secondary outcomes, including ventilator-associated pneumonia occurrence, mortality rates at ICU discharge and up to three months, duration of mechanical ventilation, ventilator-free days, and ICU length of stay. Data collection spans from initial ultrasound to ICU discharge or up to three months, ensuring comprehensive evaluation of feeding tolerance and related health outcomes.
CONDITIONS
Brief Title
Bedside Observation by Clinical Ultrasound for Stomach Expansion
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Predicted mechanical ventilation for 48 hours or more
- Started enteral nutrition via nasogastric or orogastric tube for at least 48 hours
- Free and informed consent obtained from patient's relative, legal representative, or inclusion in emergency situation
You will not qualify if you...
- History of major gastric surgery such as bypass, total gastrectomy, or biliopancreatic diversion
- Enteral nutrition via nasogastric or orogastric tube for more than 96 hours
- Enteral nutrition started before intubation
- Feeding via gastrostomy, jejunostomy, or jejunal tube
- Pregnancy
- Prognosis considered terminal
- No available ultrasound window
- Legally protected adults under curatorship, guardianship, or judicial protection
- No social security coverage
- Patient under State Medical Aid (AME)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 7 days
Participants are monitored for enteral nutrition intolerance and undergo gastric ultrasound with measurement of the antral area to assess stomach expansion.
Daily assessments during the 7-day period
Duration - Up to 3 months
Participants are observed for clinical outcomes including ventilator-associated pneumonia, mortality, duration of mechanical ventilation, ventilator-free days, and length of ICU stay.
Assessments at ICU discharge, 28 days, and 3 months
Trial Site Locations
Total: 1 location
1
Hôpital Saint Joseph Saint Luc
Lyon, France, 69007
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
PREVENTION
Number of Arms
1
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