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Gastric Ultrasound in Elective Surgical Diabetic Patients

Gastric Ultrasound in Elective Surgical Diabetic Patients

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06600035
Enrollment
130
Registered
2024-09-19
Start date
2024-09-17
Completion date
2025-04-01
Last updated
2024-09-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes Mellitus, Elective Surgery, Gastric Ultrasound

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.

Interventions

DEVICEGastric 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

Sponsors

Tanta University
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
OTHER

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Antral cross-sectional area (CSA)Just before surgeryCross-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

MeasureTime frameDescription
Gastric volumeJust before surgeryThe 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/weightJust before surgeryGastric volume/weight will be recorded.

Countries

Egypt

Contacts

Primary ContactMohammed S ElSharkawy, MD
mselsharkawy@med.tanta.edu.eg00201148207870

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026