Comparing the Effect of LTS and Air-Q3 LMA Use on Gastric Insufflation Using Ultrasound

Recruiting

• Conditions: Laryngeal Masks Comparison; Elective Surgeries; Gastric Ultrasonography; Gastric Insufflation

• Registration Number: NCT07196137
• Lead Sponsor: Ankara City Hospital Bilkent

Brief Summary

The primary objective of the study is to evaluate gastric insufflation during the use of two different airway devices (Laringeal Tube Suction and Air Q3 Laryngeal Mask.

The secondary objectives of the study are to assess these two airway devices in terms of perioperative complications.

Detailed Description

During general anesthesia, various devices are used to secure the airway. Supraglottic airway devices (SGAs) are among these and are used safely for short surgical procedures. Although SGAs are used to provide an easy and safe airway, none of them seal the trachea and ventilate only the lungs in the way that endotracheal intubation (ETT) does. Positive pressure ventilation provided at the supraglottic level cannot prevent air from escaping into the esophagus and, consequently, the stomach. Gastric distension is associated with perioperative complications such as nausea, vomiting, and aspiration, and is considered an undesirable condition by anesthesiologists.

The study aims to compare the Laryngeal Tube Suction and the Air Q3 Laryngeal Mask in terms of gastric insufflation. By measuring the diameters of the gastric antrum and recording their changes throughout the case, this study intend to evaluate the effectiveness and reliability of the two airway devices.

ASA (American Society of Anesthesiologist) I-III class pediatric patients between the ages of 1-12 who will undergo elective surgery under general anesthesia will be included in the study. Randomisation will be done with a sealed envelope. The blinded researcher will collect and record data without knowing which airway device was chosen. Blind researcher will do gastric ultrasound measurements with Butterfly IQ+ ultrasound. Another researcher will insert the airway device and after insertion patients head will be covered, this researcher will not involve during data collection. After the data is collected, the airway device releated data will be recorded by non-blind researcher seperately.

Study Timeline

• Study First Submitted: 2025-08-19
• Status Verified: 2025-09
• Study First Submitted QC: 2025-09-24
• Study Start: 2025-09-29
• Study First Posted: 2025-09-29
• Last Update Submitted: 2025-09-29
• Last Update Posted: 2025-09-30
• Primary Completion: 2026-01-01
• Study Completion: 2026-02-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Gastric Antral Cross Sectional Area (T0)	Just before anesthesia induction	First gastric measurement: Before anesthesia induction gastric ultrasound will be done and gastric antrum cross sectional area will be recorded by blinded researcher
Gastric Antral Cross Sectional Area (T2)	Just before the end of anesthesia, after the surgery is completed	Third measurement: Just before the end of anesthesia, after the surgery is completed gastric ultrasound will be done and gastric antrum cross sectional area will be recorded by blinded researcher.
Gastric Antral Cross Sectional Area (T1)	Right after the SGA is placed following anesthesia induction.	Second gastric measurement: after anesthesia induction and before the start of surgery gastric ultrasound will be done and gastric antrum cross sectional area will be recorded by blinded researcher

Secondary Outcome Measures

Name	Time	Method
LTS Cuff Pressure Measurement	Just after inserting a Laryngeal Tube Suction	If the choosen airway device is an LTS, after inserting LTS a cuff pressure measurement will be done by nonblind researcher. For masking the device that used even if a measurement is not taken, it will be treated as if it were.
Maximum Airway Pressure (PPeak)	Intraoperative	The highest pressure measured by the mechanical ventilator will be recorded.
Minimum Saturation	Intraoperative	The lowest measured saturation value.
Spasm	Intraoperative and/or postoperative 2 hours	Incidence of spasm
The time taken for airway device placement and failed placement	Intraoperative	The time from the moment the airway device is touched until end-tidal CO2 is detected (Second)
Postoperative Sore Throat	Postoperative 2 hours	Incidence of sore throat assessed by direct questioning
Postoperative Nausea and Vomitting	Postoperative 2 hours	Incidence of post operative nausea and vomitting assessed by direct questioning
Presence of blood on the supraglottic airway	Just after removing the SGA	Nonblinded researcher will check if there is blood contamination on the SGA after removing it.
Postoperative Cough	Postoperative 2 hours	Incidence of Cough assessed by direct questioning or physical examination
Need for nebulized medications or cool mist.	Postoperative 2 hours	Need for nebulized medications or cool mist for spasm or cough

Trial Locations

Locations (1)

Ankara Bilkent City Hospital Department of Anesthesiology and Reanimation; Ankara, Çankaya, Turkey (Türkiye)