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Trials / Recruiting

RecruitingNCT06600035

Gastric Ultrasound in Elective Surgical Diabetic Patients

Status
Recruiting
Phase
Study type
Observational
Enrollment
130 (estimated)
Sponsor
Tanta University · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
DEVICEGastric ultrasoundA 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

Timeline

Start date
2024-09-17
Primary completion
2025-04-01
Completion
2025-04-01
First posted
2024-09-19
Last updated
2024-09-19

Locations

1 site across 1 country: Egypt

Source: ClinicalTrials.gov record NCT06600035. Inclusion in this directory is not an endorsement.