Residual Gastric Volume Measured by Ultrasound in Diabetic Surgical Population Versus Non-diabetic Surgical Population.
Comparative Observational Study of Residual Gastric Volume Measured by Ultrasound After Preoperative Fasting in a Diabetic Surgical Population Versus a Non-diabetic Surgical Population.
1 other identifier
observational
592
1 country
1
Brief Summary
Comparison of residual gastric volume measure by ultrasounds between diabetic and non-diabetic patients scheduled for elective surgery
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Mar 2022
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 9, 2022
CompletedFirst Submitted
Initial submission to the registry
June 22, 2022
CompletedFirst Posted
Study publicly available on registry
June 28, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2024
CompletedResults Posted
Study results publicly available
May 1, 2026
CompletedMay 1, 2026
April 1, 2026
2.8 years
June 22, 2022
March 23, 2026
April 9, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Residual Gastric Volume
Residual gastric volume measured by ultrasounds as follows: Volume (mL) = 27.0 + 14.6 × CSARLD (cm²) - 1.28 × age (years)
Preoperative
Secondary Outcomes (1)
Antral Cross-Sectional Area
Preoperative
Study Arms (2)
Diabetic patients
Diabetic patients undergoing scheduled surgery
Non-diabetic patients
Non-diabetic patients undergoing sheduled surgery
Eligibility Criteria
Fasted diabetic and non-diabetic patients scheduled for surgery.
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
IBSAL
Salamanca, 37007, Spain
Related Publications (1)
Sastre JA, Lopez T, Julian R, Bustos D, Sanchis-Dux R, Molero-Diez YB, Sanchez-Tabernero A, Ruiz-Simon FA, Sanchez-Hernandez MV, Gomez-Rios MA. Assessing Full Stomach Prevalence with Ultrasound Following Preoperative Fasting in Diabetic Patients with Dysautonomia: A Comparative Observational Study. Anesth Analg. 2024 Dec 1;139(6):1300-1308. doi: 10.1213/ANE.0000000000007110. Epub 2024 Aug 8.
PMID: 39116006RESULT
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. José A. Sastre
- Organization
- Hospital Universitario de Salamanca
Study Officials
- PRINCIPAL INVESTIGATOR
José A. Sastre, MD, PhD
Anesthesiology Service. Salamanca University Hospital
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
June 22, 2022
First Posted
June 28, 2022
Study Start
March 9, 2022
Primary Completion
December 31, 2024
Study Completion
December 31, 2024
Last Updated
May 1, 2026
Results First Posted
May 1, 2026
Record last verified: 2026-04