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Gastric Ultrasound in Elective Surgical Diabetic Patients

T

Tanta University

Status

Enrolling

Conditions

Elective Surgery
Diabetes Mellitus
Gastric Ultrasound

Treatments

Device: Gastric ultrasound

Study type

Observational

Funder types

Other

Identifiers

NCT06600035
36264PR801/8/24

Details and patient eligibility

About

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

Full 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.

Enrollment

130 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

130 participants in 2 patient groups

Group I - Diabetic
Description:
Diabetic patients
Treatment:
Device: Gastric ultrasound
Group II - Non-diabetic
Description:
Non-diabetic patients
Treatment:
Device: Gastric ultrasound

Trial contacts and locations

1

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Central trial contact

Mohammed S ElSharkawy, MD

Data sourced from clinicaltrials.gov

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