Gastric Ultrasound in Elective Surgical Diabetic Patients

NCT06600035 | Recruiting

• 1 other identifier: 36264PR801/8/24
• Study Type: observational
• Target: 130
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Gastric Ultrasound; Elective Surgery; Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Gastric volume

  Just before surgery

• Gastric volume/weight

  Just before surgery

Study Arms (2)

Group I - Diabetic

Diabetic patients

Device: Gastric ultrasound

Group II - Non-diabetic

Non-diabetic patients

Device: Gastric ultrasound

Interventions

Gastric ultrasound DEVICE

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 I - Diabetic; Group II - Non-diabetic

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tanta University: lead

Study Sites (1)

Tanta University

Tanta, El-Gharbia, 31527, Egypt

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Central Study Contacts

Mohammed S ElSharkawy, MD

CONTACT

00201148207870; mselsharkawy@med.tanta.edu.eg

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of Anesthesiology, Surgical Intensive Care and Pain Medicine, Faculty of Medicine, Tanta University, Tanta, Egypt.

Study Record Dates

• First Submitted: September 12, 2024
• First Posted: September 19, 2024
• Study Start: September 17, 2024
• Primary Completion: April 1, 2025
• Study Completion: April 1, 2025
• Last Updated: September 19, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: After the end of study for one year.
• Access Criteria: The data will be available upon a reasonable request from the corresponding author

Locations

EG (1)