Tanta University
Tanta, El-Gharbia, 31527, Egypt
Location status: Recruiting
Location contact
Ahmed E Abo ElKheir, MD
PRINCIPAL_INVESTIGATOR
Mohammad H Alqassas, MD
PRINCIPAL_INVESTIGATOR
Mohammed S Elsharkawy, MD
CONTACT
NCT Number: NCT06600035
The aim of this study is to evaluate the role of gastric ultrasound in elective surgical diabetic patients.
Interested in participating?
Request Info18 year and older
All sexes
Observational
Tanta, El-Gharbia, 31527, Egypt
Location status: Recruiting
Ahmed E Abo ElKheir, MD
PRINCIPAL_INVESTIGATOR
Mohammad H Alqassas, MD
PRINCIPAL_INVESTIGATOR
Mohammed S Elsharkawy, MD
CONTACT
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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
Time frame: 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
Time frame: 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)
Time frame: Just before surgery
Gastric volume/weight will be recorded.
Contact information is provided by the study sponsor or research team.
Tanta University
Other
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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