Status:
COMPLETED
Diagnostic Performance of Gastric Ultrasound in Children
Lead Sponsor:
Hospices Civils de Lyon
Conditions:
Healthy Volunteer
Eligibility:
All Genders
1-10 years
Phase:
NA
Brief Summary
Pulmonary aspiration of gastric contents is a complication responsible for the third highest cause of anaesthesia-related mortality in France, and for 50% of airway management-related mortality in the...
Eligibility Criteria
Inclusion
- Children aged between 1 and 10 years
- Healthy volunteer, with no significant medical history (American Society of Anesthesiologists class ASA 1)
- Fasting according to the 2022 recommendations of the European Society of Anaesthesia: minimum fasting time of 1 h for clear liquids, 3 h for breast milk, 4 h for infant formula, 6 h for solid non-fatty foods and milk, 8 h for richer meals
- Informed consent signed by the child's legal representatives,
- affiliated to a social security scheme
Exclusion
- Agitation of the child preventing gastric ultrasound scans from being performed
- Non-compliance with fasting instructions
- Previous oeso-gastro-duodenal surgery
- Treatments affecting gastric motility (erythromycin, metoclopramide, etc.)
- Obesity defined by a body mass index ≥ 30 kg/m².
- Pathologies that may affect gastric volume: insulin-dependent or requiring diabetes, gastro-oesophageal reflux, scleroderma, etc.
Key Trial Info
Start Date :
December 20 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 15 2024
Estimated Enrollment :
92 Patients enrolled
Trial Details
Trial ID
NCT06079268
Start Date
December 20 2023
End Date
April 15 2024
Last Update
September 9 2025
Active Locations (1)
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1
Hopital Femme Mère Enfant
Bron, France, 69500