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NCT05435157 Clinical Trial

Residual Gastric Volume Measured by Ultrasound in Diabetic Surgical Population Versus Non-diabetic Surgical Population.

Diabetes Mellitus Clinical Trial

Official title:
Comparative Observational Study of Residual Gastric Volume Measured by Ultrasound After Preoperative Fasting in a Diabetic Surgical Population Versus a Non-diabetic Surgical Population.

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05435157
Other study ID # PI 2022 02 934
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date March 9, 2022
Est. completion date December 31, 2024

Study information
Verified date February 2024
Source Fundación Instituto de Estudios de Ciencias de la Salud de Castilla y León
Contact José A. Sastre, MD, PhD
Phone +34923291100
Email jasastre@saludcastillayleon.es
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Comparison of residual gastric volume measure by ultrasounds between diabetic and non-diabetic patients scheduled for elective surgery

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 296
Est. completion date December 31, 2024
Est. primary completion date December 31, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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.

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
Spain IBSAL Salamanca

Sponsors (1)
Lead Sponsor Collaborator
Fundación Instituto de Estudios de Ciencias de la Salud de Castilla y León

Country where clinical trial is conducted

Spain, 

Outcome
Type Measure Description Time frame Safety issue
Primary Residual gastric volume Residual gastric volume measured by ultrasounds Preoperative
Secondary Antral cross-sectional area Antral cross-sectional area measured by ultrasounds Preoperative
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