Comparative Observational Study of Residual Gastric Volume Measured by Ultrasound After Preoperative Fasting in a Diabetic Surgical Population Versus a Non-diabetic Surgical Population.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 592
- Locations
- 1
- Primary Endpoint
- Residual Gastric Volume
Study Overview
Brief Summary
Comparison of residual gastric volume measure by ultrasounds between diabetic and non-diabetic patients scheduled for elective surgery
Detailed Description
The presence of gastric content increases the risk of aspiration during general anesthesia. Delayed gastric emptying has been described in diabetic patients; for that reason, diabetic patients could have a high risk of aspiration despite adequate fasting. This study aimed to compare ultrasound-guided measurement of residual gastric volume between diabetic and non-diabetic patients scheduled for elective surgery.
Study Design
- Study Type
- Observational
- Observational Model
- Case Control
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •BMI<40 kg.m-2;
- •Age over 18 years;
- •American Society of Anesthesiologists' physical status status I-III
- •who were to undergo elective surgery and had the ability to understand the rationale of the study and provide informed consent
Exclusion Criteria
- •Pregnancy
- •Recent upper gastrointestinal bleed (< 1 month)
- •Abnormal anatomy of the upper gastrointestinal tract (such as hiatal hernias and gastric tumors)
- •Previous surgical procedures on the esophagus, stomach, or upper abdomen
- •Gastroesophageal reflux disease
- •Previous use of prokinetics or high doses of opiates.
Arms & Interventions
Diabetic patients
Diabetic patients undergoing scheduled surgery
Non-diabetic patients
Non-diabetic patients undergoing sheduled surgery
Outcomes
Primary Outcomes
Residual Gastric Volume
Time Frame: Preoperative
Residual gastric volume measured by ultrasounds as follows: Volume (mL) = 27.0 + 14.6 × CSARLD (cm²) - 1.28 × age (years)
Secondary Outcomes
- Antral Cross-Sectional Area(Preoperative)
Investigators
Jose Alfonso Sastre
Principal Investigator
Fundación Instituto de Estudios de Ciencias de la Salud de Castilla y León