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

NCT07555080 | Not Yet Recruiting

• 1 other identifier: 2025/437
• Study Type: observational
• Target: 250
• Locations: 1 country
• Sites: 1

Brief Summary

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 a 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.

Conditions

Gastric Ultrasonography; Gastric Volume; Gastric Insufflation; Airway Complications; Supraglottic Airways; Supraglottic Airway Use in Children

Keywords

gastric ultrasonography; airway management

Outcome Measures

Primary Outcomes (1)

• Comparison of gastric volume changes smong study groups

  The primary outcome is to compare the change in gastric volume calculated via ultrasound at T0 (before induction), T1 (after the airway secured), and T2 (end of the operation) among the three groups (Endotracheal tube, first-generation SAD, and second-generation SAD). This will determine whether the choice of airway device leads to a difference in gastric volume during the perioperative period.

  up to 2 hours

Secondary Outcomes (8)

• Correlation between duration of surgery and change in gastric volume

  30 minutes to 2 hours

• Antral cross sectional area changes

  up to 2 hours

• Air leakege

  up to 2 hours

• Airway pressures

  up to 2 hours

• SpO2

  up to 2 hours

Study Arms (3)

Endotracheal intubation tube

The patients who ventilated by endotracheal tube

First-generation supraglottic airway

Patients ventilated via a first-generation supraglottic airway

Second-generation supraglottic airway

Patients ventilated via a second-generation supraglottic airway

Eligibility Criteria

• Age: 1 Year - 10 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Pediatric patients (1-10 years) undergoing elective surgery

You may qualify if:

• years of age
• Adherence to standard preoperative fasting guidelines
• Elective surgeries
• ASA I-III status
• Surgery time 30 min to 2 hours

You may not qualify if:

• Gastrointestinal tract surgeries
• Laparoscopic surgeries
• Emergency procedures
• Full stomach patients
• Lack of parental/guardian consent

Sponsors & Collaborators

• Istanbul University: lead

Study Sites (1)

Istanbul University

Istanbul, Turkey (Türkiye)

Location

Related Publications (3)

• 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.

  PMID: 36960139 BACKGROUND

• 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.

  PMID: 22956643 BACKGROUND

• 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.

  PMID: 26239668 BACKGROUND

Study Officials

• Meltem Savran Karadeniz

  Istanbul University Faculty of Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Meltem Savran Karadeniz, Professor

CONTACT

+9005334845563; mskaradeniz@gmail.com

Zeynep Sandikci, Resident

CONTACT

+905396076093; zeynepsandikcii@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 21, 2026
• First Posted: April 28, 2026
• Study Start: June 15, 2026
• Primary Completion: August 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: June 8, 2026

Record last verified: 2026-06

Locations

TU (1)