Evaluation of Preoperative Gastric Ultrasonography in Pediatric Patients in Terms of Patient Safety

Evaluation of Preoperative Gastric Ultrasonography in Pediatric Patients in Terms of Patient Safety in Non-Operating Room Anesthesia Applications

Preoperative evaluation of stomach fullness with ultrasound in children who will undergo anesthesia outside the operating room

Study Overview

• Status: Recruiting
• Conditions: Gastric Ultrasound; Nonoperating Room Anesthesia

Detailed Description

Determining the gastric contents and volume by preoperative gastric ultrasound in pediatric patients and defining its relationship with the risk of postoperative aspiration.

• Study Type: Observational
• Enrollment (Estimated): 200

Contacts and Locations

• Study Contact: Name: Özlem OZ GERGIN, MD; Phone Number: 09005332466396; Email: oozgergin@erciyes.edu.tr

Study Locations

• Turkey (Türkiye)
  • Kayseri, Turkey (Türkiye)
    • Recruiting
    • Erciyes University
    • Contact: Erciyes U

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

ASA I-II children aged 0-18 years who underwent non-operating room anesthesia

Description

Inclusion Criteria:

• Children between 0-18 years of age and ASA I-II patients will be included in the study.

Exclusion Criteria:

• Patients over 18 years of age,
• ASA-III and above patients,
• patients with gastrointestinal dysfunction,
• patients who cannot assume the lateral decubitus position for gastric -ultrasound measurements,
• those who have had previous lower esophageal or gastric surgery,
• those who do not comply with institutional fasting guidelines,
• those with concomitant systemic diseases affecting gastric emptying,
• those with a high body mass index (BMI) > 40 kg/m2,
• those with gastroesophageal reflux or aspiration risk factors, and emergency cases with delayed gastric emptying despite appropriate fasting time will not be included in the study.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Group undergoing gastric ultrasound; Children between 0-18 years of age and ASA I-II patients will be included in the study. Stomach contents and volume will be determined with ultrasound and the postoperative effects of the values found will be examined. Gastric ultrasound will be performed before anesthesia induction, with children in the supine and lateral decubitus positions, using either a linear high-frequency or abdominal probe, depending on the age of the child, to obtain a sagittal section of the antrum in a plane that includes the left lobe of the liver and the aorta.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Qualitative assessment of residual gastric fluid volume	Grade 0: Defined as no contents visible in the antrum, the stomach is empty and the volume of the contents approaches zero. Grade 1: Visible clear fluid with a fluid volume of <1.5 mL/kg. Grade 2: Defined as visible clear fluid with a fluid volume of >1.5 mL/kg in both the supine and lateral decubitus positions.	preoperative evaluation in the operating room

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Gastric content volume	It will be calculated using a mathematical model validated in children aged 11 months to 18 years. Volume(mL/kg) = [-7.8 + 0.035 × antral area measured in lateral decubitus position (mm2) + 0.127 × age (months)] / body weight (kg). The R² value for this model was 0.60.	preoperative evaluation in the operating room
Antral cross-sectional area	In both supine and lateral decubitus positions, between antral contractions, serosa to serosa, measuring the length diameter (D1) and the anteroposterior diameter (D2); Antral area = (π × D1 × D2) / 4 will be measured using the formula.	preoperative evaluation in the operating room

Collaborators and Investigators

• Sponsor: TC Erciyes University

Study record dates

Study Major Dates

• Study Start (Actual): November 15, 2024
• Primary Completion (Estimated): July 31, 2026
• Study Completion (Estimated): September 30, 2026

Study Registration Dates

• First Submitted: May 6, 2026
• First Submitted That Met QC Criteria: May 6, 2026
• First Posted (Actual): May 12, 2026

Study Record Updates

• Last Update Posted (Actual): May 12, 2026
• Last Update Submitted That Met QC Criteria: May 6, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: gastric ultrasound; nonoperating room anesthesia; pediatric nonoperating room anesthesia
• Other Study ID Numbers: 2024/163 (Ordu University Ethics Committee)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No