Comparison of Gastric Volume Changes After Ventilation With Endotraceal Tube, First Generation Supraglottic Airway and Second Generation Supraglottic Airway in Pediatric Patients

Comparison of Gastric Volume Changes Via Ultrasonographic Measurements After Ventilation With Endotraceal Tube, First Generation Supraglottic Airway and Second Generation Supraglottic Airway in Pediatric Patients . A Prospective Observational Study

This study aims to compare the gastric volumes of pediatric patients undergoing positive pressure ventilation with different airway management techniques. Gastric ultrasound is a non-invasive bedside tool with high sensitivity and specificity for determining the nature and amount of gastric content. In pediatric cases, maintaining a gastric volume below 1.25 ml/kg is associated with a lower risk of perioperative aspiration.

Although supraglottic airway devices (SADs) are commonly used as alternatives to endotracheal tubes, concerns regarding the potential for gastric insufflation and subsequent aspiration persist. Second-generation SADs were specifically designed with gastric drainage channels to mitigate the risk of regurgitation compared to first-generation devices.

The primary objective of this study is to determine whether there is difference in gastric volumes, as measured by ultrasound, among three groups of pediatric patients: those managed with endotracheal tubes, first-generation SADs, and second-generation SADs. By comparing these measurements post-ventilation, the investigators aim to evaluate the impact of the airway device choice on gastric volume under clinical conditions.

Study Overview

• Status: Not yet recruiting
• Conditions: Gastric Insufflation; Gastric Volume; Airway Complications; Gastric Ultrasonography; Supraglottic Airway Use in Children; Supraglottic Airways

Detailed Description

All participants will receive a standard preoperative intravenous (IV) dose of 0.1 mg/kg midazolam in the preparation room. Upon arrival at the operating room, routine monitoring will be established for all patients, including electrocardiography (ECG), non-invasive blood pressure (NIBP), and peripheral oxygen saturation (SpO2). Before the induction of anesthesia(T0), the gastric antral area will be evaluated using ultrasound in the right lateral decubitus (RLD) position. A high-frequency linear probe will be placed sagittally in the epigastric region to visualize the stomach antrum, located posterior to the left lobe of the liver and anterior to the abdominal aorta. The largest and smallest diameters (d1 and d2) of the elliptical antrum will be measured. The Antral Cross-Sectional Area (CSA) will be calculated using the formula: CSA = d1*d2*pi/4. Gastric volume will then be derived using the validated pediatric formula: [0.035*CSA(mm2) + 0.127*age(months) - 7.8] / body weight (kg). Standard general anesthesia induction will be performed using sevoflurane and oxygen inhalation, 1 mcg/kg IV fentanyl, and 0.5 mg/kg IV rocuronium. Following induction, patients will be managed with either endotracheal intubation or a supraglottic airway device (SAD). The choice of airway management will follow routine clinical practice. SAD size and cuff inflation volume will adhere to the manufacturer's recommendations. Any volume leakage during ventilation will be recorded as a percentage. Anesthesia maintenance will be provided with 1 MAC sevoflurane in an oxygen/air mixture. The gastric antral area will be re-evaluated via ultrasound in the RLD position at two additional time points: T1: Immediately after the airway device is secured and ventilation is established, before the start of surgery. T2: At the end of the surgical procedure, before the patient is emerged from anesthesia. All relevant clinical data will be recorded in the patient follow-up form, including age, gender, height, weight, duration of surgery, vital signs, type of airway device used, perioperative airway pressures, and any observed complications. Following the final measurement, patients will be emerged from anesthesia and transferred to the postoperative recovery room according to standard protocols.

• Study Type: Observational
• Enrollment (Estimated): 250

Contacts and Locations

• Study Contact: Name: Meltem Savran Karadeniz, professor; Phone Number: +9005334845563; Email: mskaradeniz@gmail.com
• Study Contact Backup: Name: Zeynep Sandikci, Resident; Phone Number: +905396076093; Email: zeynepsandikcii@gmail.com

Study Locations

• Turkey (Türkiye)
  • Istanbul, Turkey (Türkiye)
    • Istanbul University
    • Contact: Meltem Savran Karadeniz, professor; Phone Number: 009005334845563; Email: mskaradeniz@gmail.com

Participation Criteria

Eligibility Criteria

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

• Sampling Method: Non-Probability Sample

Study Population

Patients between 1-10 years of age who undergo elective surgery

Description

Inclusion Criteria:

1-10 years of age suggested preoperative npo elective surgery asa 1-3 status surgery time 30 min - 2 hours

Exclusion Criteria:

gastrointestinal tract surgery laparoscopic surgery emergency procedures full stomach patients Patients without parental consent

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort
Endotracheal entubation tube; The patients who ventilated by endotracheal tube
First generation supraglottic airway; The patients who ventilated via first generation supraglottic airway
Second generation supraglottic airway; The patients who ventilated via first generation supraglottic airway

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Comparison of Gastric Volume Changes Among Study Groups	The primary outcome is to compare the change in gastric volume which calculated via ultrasound at T0 (before induction), T1 (after airway secured) and T2 (end of the operation) among the three groups (Endotracheal tube, first generation supraglottik airway device(SAD) and second generation SAD). This will determine if the choice of airway device leads to a difference in gastric volume accumulation during the perioperative period.	up to 2 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Correlation Between Duration of Surgery and Change in Gastric Volume	Total duration of the surgical procedure and the change in gastric volume	30 minutes to 2 hours
Antral cross sectional area changes	Meauserement of antral cross sectional area at T0, T1 and T2 on lateral decubitis position	up to 2 hours
Air leakege	Air leakage percentage with different airway devices	up to 2 hours
Airway pressures	Peak airway pressures during surgery duration	up to 2 hours
SpO2	pulse oximeter	up to 2 hours
Heart rate	ECG monitoring	up to 2 hours
Mean arteryal pressure	Non invasive blood pressure measurement	up to 2 hours
Airway complications	Perioperative airway complications such as bronchospasm, laryngospasm etc. will be noted	up to 3 hours

Collaborators and Investigators

• Sponsor: Istanbul University

Publications and helpful links

General Publications

• Pan S, Lin C, Tsui BCH. Neonatal and paediatric point-of-care ultrasound review. Australas J Ultrasound Med. 2022 Oct 13;26(1):46-58. doi: 10.1002/ajum.12322. eCollection 2023 Feb.
• Theiler L, Gutzmann M, Kleine-Brueggeney M, Urwyler N, Kaempfen B, Greif R. i-gel supraglottic airway in clinical practice: a prospective observational multicentre study. Br J Anaesth. 2012 Dec;109(6):990-5. doi: 10.1093/bja/aes309. Epub 2012 Sep 6.
• Alakkad H, Kruisselbrink R, Chin KJ, Niazi AU, Abbas S, Chan VW, Perlas A. Point-of-care ultrasound defines gastric content and changes the anesthetic management of elective surgical patients who have not followed fasting instructions: a prospective case series. Can J Anaesth. 2015 Nov;62(11):1188-95. doi: 10.1007/s12630-015-0449-1. Epub 2015 Aug 4.

Study record dates

Study Major Dates

• Study Start (Estimated): May 1, 2026
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): September 1, 2026

Study Registration Dates

• First Submitted: April 21, 2026
• First Submitted That Met QC Criteria: April 21, 2026
• First Posted (Actual): April 28, 2026

Study Record Updates

• Last Update Posted (Actual): April 28, 2026
• Last Update Submitted That Met QC Criteria: April 21, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: airway management; gastric ultrasonography
• Other Study ID Numbers: 2025/437

Drug and device information, study documents

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