An observational study in Gastric Ultrasound, Elective Surgery and Diabetes Mellitus, sponsored by Tanta University. Recruiting at 1 site in Egypt. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-09-19.
Sponsored by Tanta University · Observational
The aim of this study is to evaluate the role of gastric ultrasound in elective surgical diabetic patients.
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.
10,925 studies on the registry are indexed under Diabetes Mellitus; 1,319 are open to participants now.
This study's planned enrollment of 130 is below the median of 233 across 2,220 observational studies indexed under Diabetes Mellitus.
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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.
Exclusion Criteria:
Diabetic patients
Device: Gastric ultrasound
Non-diabetic patients
Device: Gastric 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
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
Time frame: Just before surgery
Gastric volume
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
Gastric volume/weight will be recorded.
Time frame: Just before surgery
Plan to share: Yes — The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
Supporting information: Study protocol
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