A Cohort Study of Ultrasound Evaluation of Gastric Emptying in Diabetic Patients: a Comparison With Non-diabetic Controls
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- West China Hospital
- Enrollment
- 108
- Locations
- 1
- Primary Endpoint
- Prevalence of full stomach
Study Overview
Brief Summary
This is a prospective cohort study. The main objective is to compare the prevalence of a "full stomach" using gastric ultrasound technique, in elective surgical patients with diabetes mellitus compared to non-diabetic controls following the present fasting guidelines (2 h after clear liquid and 6h after a light meal). For patients with a full stomach or intermediate stomach, an consecutive ultrasound scan is performed every 10 min,until empty stomachstomach contents are detected to determine the mean gastric emptying time for clear liquid and light meal, and to investigate the risk factors for delayed stomach emptying in diabetic patients by logistic regression analysis .
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •diabetes (two fasting plasma glucose concentration≥7mmol/L or casual plasma glucose concentration≥11.1mmol/L);
- •age≥18 yr; ASA physical status I-III;
- •body mass index <35kg/m2;
- •who are admitted to the surgical department;
- •who are able to understand the rationale of the study and provide informed consent.
Exclusion Criteria
- •pregnancy;
- •a history of upper gastrointestinal disease or previous surgery on the oesophagus, stomach or upper abdomen;
- •documented abnormalities of the upper gastrointestinal tract such as gastric tumors;
- •recent upper gastrointestinal bleeding (within the preceding 1 month);
- •taking medicines that may delay gastric emptying(e.g., anticholinergic agents).
- •hypothyroidism.
Outcomes
Primary Outcomes
Prevalence of full stomach
Time Frame: one day
The frequency of a "full stomach" in the diabetic population compared to a non-diabetic control population at 2h after ingesting clear liquid or 6h after light meal.
Secondary Outcomes
- Mean gastric emptying time of clear liquid and light meal(one day)
Investigators
Chunling Jiang
Professor
West China Hospital