Status:
NOT_YET_RECRUITING
Stomach Processing and Emptying Evaluation With Diet and Ultrasound
Lead Sponsor:
Medical University of Warsaw
Conditions:
Gastric Emptying
Preoperative Risk Assessment
Eligibility:
All Genders
18-40 years
Phase:
NA
Brief Summary
Gastric content is a key risk factor for aspiration during anesthesia. Although standard fasting times are recommended, various factors-including GLP-1 receptor agonists,-can delay gastric emptying. G...
Detailed Description
Pulmonary aspiration of gastric contents is a serious and potentially life-threatening complication of anesthesia. Despite adherence to preoperative fasting guidelines issued by the American Society o...
Eligibility Criteria
Inclusion
- Age between 18 and 40 years
- Ability and willingness to provide written informed consent
- Agreement to comply with study procedures, including pre-study dietary restrictions
- No history of gastrointestinal disease
- No recent abdominal surgery
Exclusion
- Lack of informed consent
- Allergy or intolerance to any of the foods used in the study meals
- Medical conditions known to delay gastric emptying, including:
- Obesity (BMI \> 30 kg/m²)
- Diabetes mellitus
- Gastroesophageal reflux disease (GERD)
- Hiatal hernia
- Bowel obstruction
- Tube feeding
- Active gastrointestinal disease
- History of gastrointestinal surgery
- Current pregnancy or breastfeeding
- Use of medications affecting gastric motility (e.g., opioids, anticholinergics, GLP-1 receptor agonists)
- Neuromuscular disorders impairing ability to remain in supine position for 6 hours or to walk for 30 minutes
Key Trial Info
Start Date :
June 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2026
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT06988397
Start Date
June 1 2025
End Date
June 1 2026
Last Update
May 23 2025
Active Locations (1)
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1
Medical University of Warsaw
Warsaw, Masovian Voivodeship, Poland, 02091