Clinical trial NCT06600035: Gastric Ultrasound in Elective Surgical Diabetic Patients
Official title: Gastric Ultrasound in Elective Surgical Diabetic Patients
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Gastric Ultrasound
Elective Surgery
Diabetes Mellitus
Lead sponsor: Tanta University
Sponsor class: OTHER
First posted: 2024-09-19
Enrollment: 130
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

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

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Antral cross-sectional area (CSA)
timeFrame: Just before surgery
Secondary outcomes:
measure: Gastric volume
timeFrame: Just before surgery
measure: Gastric volume/weight
timeFrame: Just before surgery
Other outcomes:
Locations:
city: Tanta
country: Egypt
facility: Tanta University
state: El-Gharbia
Study officials:
References: