- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05435157
Residual Gastric Volume Measured by Ultrasound in Diabetic Surgical Population Versus Non-diabetic Surgical Population.
February 21, 2024 updated by: Jose Alfonso Sastre, Fundación Instituto de Estudios de Ciencias de la Salud de Castilla y León
Comparative Observational Study of Residual Gastric Volume Measured by Ultrasound After Preoperative Fasting in a Diabetic Surgical Population Versus a Non-diabetic Surgical Population.
Comparison of residual gastric volume measure by ultrasounds between diabetic and non-diabetic patients scheduled for elective surgery
Study Overview
Status
Recruiting
Conditions
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 Type
Observational
Enrollment (Estimated)
296
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: José A. Sastre, MD, PhD
- Phone Number: +34923291100
- Email: jasastre@saludcastillayleon.es
Study Locations
-
-
-
Salamanca, Spain, 37007
- Recruiting
- IBSAL
-
Contact:
- José A. Sastre, MD, PhD
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Sampling Method
Non-Probability Sample
Study Population
Fasted diabetic and non-diabetic patients scheduled for surgery.
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
---|
Diabetic patients
Diabetic patients undergoing scheduled surgery
|
Non-diabetic patients
Non-diabetic patients undergoing sheduled surgery
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Residual gastric volume
Time Frame: Preoperative
|
Residual gastric volume measured by ultrasounds
|
Preoperative
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Antral cross-sectional area
Time Frame: Preoperative
|
Antral cross-sectional area measured by ultrasounds
|
Preoperative
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: José A. Sastre, MD, PhD, Anesthesiology Service. Salamanca University Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 9, 2022
Primary Completion (Estimated)
December 31, 2024
Study Completion (Estimated)
December 31, 2024
Study Registration Dates
First Submitted
June 22, 2022
First Submitted That Met QC Criteria
June 22, 2022
First Posted (Actual)
June 28, 2022
Study Record Updates
Last Update Posted (Actual)
February 22, 2024
Last Update Submitted That Met QC Criteria
February 21, 2024
Last Verified
February 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- PI 2022 02 934
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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