Gastric Ultrasound in Elective Surgical Diabetic Patients

The aim of this study is to evaluate the role of gastric ultrasound in elective surgical diabetic patients.

Study Overview

• Status: Recruiting
• Conditions: Diabetes Mellitus; Elective Surgery; Gastric Ultrasound
• Intervention / Treatment: Device: Gastric ultrasound

Detailed Description

Aspiration of gastric contents during perioperative period is a grave complication with significant morbidity and mortality. The overall incidence of gastric content aspiration ranges between <0.1% and 19% and aspiration pneumonia account for 9% of all anesthesia-related mortality. Mendelson described the pathophysiological mechanisms of pulmonary aspiration, which led to the development of strategies to prevent pulmonary aspiration.

Consequently, American Society of Anesthesiologists (ASA) released preoperative fasting guidelines for healthy patients undergoing elective surgery, in order to reduce gastric content volume and minimize the risk of aspiration. However, there are still many situations where the ASA fasting guidelines may be not suitable, including urgent or emergency situations and medical conditions such as diabetes mellitus.

Ultrasound is widely available and has been proven to be a reliable, bedside assessment tool for real-time evaluation of gastric contents. As diabetic patients are prone to have an inadequately empty stomach even after an adequate fasting, ultrasound can be used prior to induction for screening the fasting gastric volume (GV) of diabetic patients and see if it is more than the recommended safe limit.

As a novel point-of-care application, ultrasound sonography allows anesthesiologists to evaluate a patient's gastric content and volume at the bedside and helps guide anesthetic and airway management.

• Study Type: Observational
• Enrollment (Estimated): 130

Contacts and Locations

• Study Contact: Name: Mohammed S Elsharkawy, MD; Phone Number: 00201148207870; Email: mselsharkawy@med.tanta.edu.eg

Study Locations

• Egypt
  • El-Gharbia
    • Tanta, El-Gharbia, Egypt, 31527
      • Recruiting
      • Tanta University
      • Contact: Mohammed S Elsharkawy, MD; Phone Number: 00201148207870; Email: mselsharkawy@med.tanta.edu.eg
      • Principal Investigator: Ahmed E Abo ElKheir, MD
      • Principal Investigator: Mohammad H Alqassas, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

This case-control study will be carried out on 130 cases, aged ≥ 18 years, undergoing elective surgery at Tanta University Hospitals after approval from the institutional ethical committee.

Description

Inclusion Criteria:

• Age ≥ 18 years.
• Both sexes.
• Undergoing elective surgery.

Exclusion Criteria:

• American Society of Anesthesiology (ASA) physical status >III.
• Body mass index (BMI) outside the range of 18.5-40 Kg/m2.
• History of upper gastrointestinal disease or previous surgery on the esophagus, stomach, or upper abdomen.
• Abnormalities of the upper gastrointestinal tract, such as gastric tumors and recent upper gastrointestinal bleeding (within the preceding 1 month).
• Taking preoperative medicines that may delay gastric emptying (e.g., anticholinergic agents, opioids).
• Hypothyroidism.
• Current smoking history.
• Pregnancy.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Group I - Diabetic; Diabetic patients	Device: Gastric ultrasound; A curved array, low-frequency (2-5 MHz) transducer providing a scan depth up to 30 cm will be used. Patients will be scanned in the supine position followed by right lateral decubitus (RLD) position. The sonographic appearance of the gastric antrum will be classified as Grade 0,1 or 2, signifying empty antrum, fluid detected in RLD position only and antral fluid in both supine and RLD positions, respectively, based on the appearance in both the positions. Cross-sectional area (CSA) will be calculated by using two perpendicular diameters-anteroposterior (AP) and craniocaudal (CC) and the formula for area of an ellipse:CSA = (AP × CC × π)/4
Group II - Non-diabetic; Non-diabetic patients	Device: Gastric ultrasound; A curved array, low-frequency (2-5 MHz) transducer providing a scan depth up to 30 cm will be used. Patients will be scanned in the supine position followed by right lateral decubitus (RLD) position. The sonographic appearance of the gastric antrum will be classified as Grade 0,1 or 2, signifying empty antrum, fluid detected in RLD position only and antral fluid in both supine and RLD positions, respectively, based on the appearance in both the positions. Cross-sectional area (CSA) will be calculated by using two perpendicular diameters-anteroposterior (AP) and craniocaudal (CC) and the formula for area of an ellipse:CSA = (AP × CC × π)/4

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Antral cross-sectional area (CSA)	Cross-sectional area (CSA) will be calculated by using two perpendicular diameters-anteroposterior (AP) and craniocaudal (CC) and the formula for area of an ellipse: CSA = (AP × CC × π)/4	Just before surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Gastric volume	The gastric volume will be calculated using the previously validated formula: GVe (gastric volume in ml) = 27.0 + [14.6 × right - lateral CSA (cm2)] - (1.28 × age)	Just before surgery
Gastric volume/weight	Gastric volume/weight will be recorded.	Just before surgery

Collaborators and Investigators

• Sponsor: Tanta University

Study record dates

Study Major Dates

• Study Start (Actual): September 17, 2024
• Primary Completion (Estimated): April 1, 2025
• Study Completion (Estimated): April 1, 2025

Study Registration Dates

• First Submitted: September 12, 2024
• First Submitted That Met QC Criteria: September 17, 2024
• First Posted (Estimated): September 19, 2024

Study Record Updates

• Last Update Posted (Estimated): September 19, 2024
• Last Update Submitted That Met QC Criteria: September 17, 2024
• Last Verified: September 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus
• Other Study ID Numbers: 36264PR801/8/24

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
• IPD Sharing Time Frame: After the end of study for one year.
• IPD Sharing Access Criteria: The data will be available upon a reasonable request from the corresponding author
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No