Gastric Ultrasound in Elective Surgical Diabetic Patients

Recruiting

• Conditions: Gastric Ultrasound; Elective Surgery; Diabetes Mellitus
• Interventions: Device: Gastric ultrasound

• Registration Number: NCT06600035
• Lead Sponsor: Tanta University

Brief Summary

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

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 Timeline

• Status Verified: 2024-09
• Study First Submitted: 2024-09-12
• Study Start: 2024-09-17
• Study First Submitted QC: 2024-09-17
• Last Update Submitted: 2024-09-17
• Study First Posted: 2024-09-19
• Last Update Posted: 2024-09-19
• Primary Completion: 2025-04-01
• Study Completion: 2025-04-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 130

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Group I - Diabetic	Gastric ultrasound	Diabetic patients
Group II - Non-diabetic	Gastric ultrasound	Non-diabetic patients

Primary Outcome Measures

Name	Time	Method
Antral cross-sectional area (CSA)	Just before surgery	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

Secondary Outcome Measures

Name	Time	Method
Gastric volume	Just before surgery	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)
Gastric volume/weight	Just before surgery	Gastric volume/weight will be recorded.

Trial Locations

Locations (1)

Tanta University; 🇪🇬 Tanta, El-Gharbia, Egypt