Preoperative Residual Gastric Volume

NCT07031414 | Active Not Recruiting

• 1 other identifier: IZMIR CITY HOSPİTAL
• Study Type: observational
• Target: 400
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this observational study is to assess the preoperative gastric residual volume in adult patients undergoing elective surgery. The main question it aims to answer is: Does gastric residual volume, content type, and aspiration risk differ between diabetic and non-diabetic patients with similar fasting durations? Participants undergoing elective surgery will receive bedside gastric ultrasound as part of their preoperative assessment. Ultrasound images will be used to estimate gastric volume and evaluate aspiration risk.

Conditions

Preoperative; Gastric; Residual Volume

Keywords

Ultrasonography-Guided; Residual gastric volume; Diabetes mellitus

Outcome Measures

Primary Outcomes (1)

• Residual gastric volume (mL) measured by bedside ultrasound in diabetic vs. non-diabetic patients.

  The main question of the study is whether gastric emptying is delayed in diabetic patients, resulting in a higher residual gastric volume.

  Immediately before induction of anesthesia (preoperative period)

Study Arms (1)

Diabetic Group - Patients with a diagnosis of diabetes mellitus Non-Diabetic Group - Patients witho

Diabetic Group Adult patients (aged 18-65) with a known diagnosis of diabetes mellitus who are scheduled for elective surgery under general anesthesia. These participants will undergo preoperative bedside gastric ultrasound to evaluate residual gastric volume, content type, and aspiration risk. Non-Diabetic Group Adult patients (aged 18-65) without diabetes mellitus, scheduled for elective surgery under general anesthesia. These participants will also undergo preoperative bedside gastric ultrasound for the same assessments as the diabetic group.

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population will consist of adult patients aged 18 to 65 years, of both sexes, who are scheduled for elective surgery under general anesthesia. Participants will be classified into two groups: those with a documented history of diabetes mellitus (diabetic group) and those without (non-diabetic group). All patients will have American Society of Anesthesiologists (ASA) physical status I-III. The study will be conducted at Izmir City Hospital, and only patients who provide written informed consent will be included.

You may qualify if:

• Aged 18 to 65 years,
• American Society of Anesthesiologists (ASA) physical status I -III
• Scheduled for elective surgery under general anesthesia.
• Patients with a known history of diabetes mellitus will be included in the diabetic group.

You may not qualify if:

• Pregnant patients
• Patients with gastrointestinal obstructive diseases
• Patients with gastroesophageal reflux disease
• History of gastrointestinal surgery
• Emergency surgery cases
• Recent history of abdominal trauma
• Non-diabetic patients with autonomic or neurological disorders
• Patients with chronic kidney disease

Sponsors & Collaborators

• Izmir City Hospital: lead

Study Sites (1)

University of Health Sciences, Izmir Faculty of Medicine, Izmir City Hospital

Izmir, 35150, Turkey (Türkiye)

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

No specimen

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Derya A. Yurtlu, M.D.

  Izmir City Hospital, Izmir, TURKEY

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Months
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 12, 2025
• First Posted: June 22, 2025
• Study Start: March 15, 2025
• Primary Completion: August 15, 2025
• Study Completion: August 15, 2025
• Last Updated: June 22, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)