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NCT Number: NCT06600035

Gastric Ultrasound in Elective Surgical Diabetic Patients

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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

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

[email protected]

00201148207870

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Gastric ultrasound

Device

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

Primary outcomes

  1. Antral cross-sectional area (CSA)

    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

Secondary outcomes

  1. Gastric volume

    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)

  2. Gastric volume/weight

    Time frame: Just before surgery

    Gastric volume/weight will be recorded.

Study contacts

Contact information is provided by the study sponsor or research team.

Mohammed S ElSharkawy, MD

CONTACT

[email protected]

00201148207870

Sponsors and collaborators

Lead sponsor

Tanta University

Other

Registry information

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Sep 19, 2024
Registry last updated
Sep 19, 2024

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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