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

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

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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