Gastric Ultrasound in Elective Surgical Diabetic Patients

Обзор

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

Подробное описание

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.

Вмешательства

• Устройство 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 calcu

Первичные конечные точки

• Antral cross-sectional area (CSA) [Срок оценки: Just before surgery]

Вторичные конечные точки (2)

• Gastric volume [Срок оценки: Just before surgery]
• Gastric volume/weight [Срок оценки: Just before surgery]

Критерии участия

Критерии включения

• Age ≥ 18 years.
• Both sexes.
• Undergoing elective surgery.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Случай-контроль

Центры проведения

Египет · 1 центр

• Tanta University — Tanta

Идентификаторы

NCT: NCT06600035 · 36264PR801/8/24

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗