Gastric Ultrasound in Diabetic Patients

January 4, 2024 updated by: Bengü Gülhan Köksal, Zonguldak Bulent Ecevit University

Preoperative Evaluation of Gastric Contents in Diabetic Patients With Gastric Ultrasound

The American Society of Anesthesiologists (ASA) does not specify a fasting period for patients with certain comorbidities, such as diabetes, for elective surgery, and does not make a separate recommendation for surgery.

The European Society of Anesthesiology (ESA) guidelines do not differentiate between diabetic patients and normal patients. Aspiration of gastric contents is a common cause of perioperative morbidity and mortality.

Aspiration can cause hypoxia, bronchospasm, pneumonia, acute respiratory distress syndrome and death.

The presence of food or fluid in the stomach before induction of anesthesia is one of the greatest risk factors for perioperative pulmonary aspiration. Sedation and general anesthesia suppress or inhibit physiologic mechanisms (tone of the lower esophageal sphincter and upper airway reflexes) that protect against aspiration.

Because restriction of fluid and food intake before general anesthesia is vital for patient safety, Anesthesiology societies have developed guidelines for preoperative fasting.

Current ASA guidelines recommend at least 2 hours fasting for clear liquids, 6 hours fasting after a light meal (toast and clear liquids) and 8 hours fasting after a high calorie or fat meal. The information obtained from gastric ultrasound allows anesthesiologists to determine the optimal timing of procedures, type of anesthesia and airway management technique.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
    • Kozlu
      • Zonguldak, Kozlu, Turkey, 67600
        • Zonguldak Bülent Ecevit University medicine faculty

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Probability Sample

Study Population

Diabetic and non-diabetic patients aged 40-65 years undergoing ASA I-III elective surgery

Description

Inclusion Criteria:

  • Written informed consent obtained 40-65 BMI<40 ASA I-III Fasting for at least 8 hours Elective surgery

Exclusion Criteria:

  • Pregnancy Upper gastrointestinal malignancy Large Hiatal Hernia Kidney failure Liver failure Opioid use Use of drugs affecting motility Previous upper abdominal surgery BMI ≥40 kg/m2 Emergency surgery Diabetic ketoacidosis Sepsis

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
Intervention / Treatment
Group D
Group Diabetic
Procedure: Gastric ultrasound
performing gastric ultrasound to determine gastric contents
Group Control
Non-diabetic patients
Procedure: Gastric ultrasound
performing gastric ultrasound to determine gastric contents

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
determine stomach fullness
Time Frame: baseline (before intubation)
To evaluate residual gastric volume in diabetic patients fasting for elective surgery
baseline (before intubation)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of risk factors
Time Frame: during surgery
Investigating risk factors for a full stomach in diabetic patients
during surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Zonguldak Bulent Ecevit University

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)

October 15, 2022

Primary Completion (Estimated)

January 31, 2024

Study Completion (Estimated)

December 1, 2024

Study Registration Dates

First Submitted

November 24, 2023

First Submitted That Met QC Criteria

January 4, 2024

First Posted (Estimated)

January 8, 2024

Study Record Updates

Last Update Posted (Estimated)

January 8, 2024

Last Update Submitted That Met QC Criteria

January 4, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 2022/17-1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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