An observational study in Laryngeal Masks Comparison, Elective Surgeries and Gastric Ultrasonography, sponsored by Ankara City Hospital Bilkent. Completed at 1 site in Turkey (Türkiye). Open to participants aged 1 Year to 12 Years. Per ClinicalTrials.gov, last updated 2026-05-07.
Sponsored by Ankara City Hospital Bilkent · Observational
The primary objective of the study is to evaluate gastric insufflation during the use of two different airway devices (Laringeal Tube Suction and Air Q sp3G Laryngeal Mask.
The secondary objectives of the study are to assess these two airway devices in terms of perioperative complications.
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 Q sp3G 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.
Ankara City Hospital Bilkent is the lead sponsor of 424 studies on the registry; 105 are open to participants now.
Counted across the registry records on this site, refreshed daily.
ASA I-III class, ages between 1-12, patients who will undergo elective surgery under standard general anesthesia
Patients with an ASA score of I-III for whom a supraglottic airway (SGA) is planned.
Operation time less than 2 hours. Patients who have read and accepted the informed consent form. Patients between the ages of 1 and 12, or their guardians, will be included in the study.
Exclusion criteria:
Patients who do not meet perioperative fasting criteria. Patients whose stomachs are not considered empty during the initial gastric ultrasound.
Patients with a known difficult airway. Patients with oropharyngeal or laryngeal anomalies. Patients who require the use of neuromuscular blockers. Patients with a history of a previously failed SGA placement. Patients with known reflux. Patients who do not give consent will not be included in the study.
After obtaining consent, patients will be asked to choose their airway device using a sealed envelope method. The patients' demographic data and ASA scores will be recorded. Gastric antrum diameters will be recorded at the beginning of the case, before induction. After the airway device is placed, the antrum diameters will be recorded. The antrum diameters will be recorded again after the surgery is complete, before the airway device is removed. Mechanical ventilator settings will be recorded. To ensure standardization, the tidal volume will be set to 7 ml per kg. No PEEP will be applied. Volume-controlled ventilation will be used. The lowest intraoperative saturation and the highest peak pressure that occurred will be recorded.The cuff pressure will be recorded after being inflated with the recommended volume. The time taken for airway device placement (the time from when it is picked up until Endtidal CO2 is observed) and any failed placements will be recorded.
After obtaining consent, patients will be asked to choose their airway device using a sealed envelope method. The patients' demographic data and ASA scores will be recorded. Gastric antrum diameters will be recorded at the beginning of the case, before induction. After the airway device is placed, the antrum diameters will be recorded. The antrum diameters will be recorded again after the surgery is complete, before the airway device is removed. Mechanical ventilator settings will be recorded. To ensure standardization, the tidal volume will be set to 7 ml per kg. No PEEP will be applied. Volume-controlled ventilation will be used. The lowest intraoperative saturation and the highest peak pressure that occurred will be recorded.The cuff pressure will be recorded after being inflated with the recommended volume. The time taken for airway device placement (the time from when it is picked up until Endtidal CO2 is observed) and any failed placements will be recorded.
Gastric Antral Cross Sectional Area (T0)
First gastric measurement: Before anesthesia induction gastric ultrasound will be done and gastric antrum cross sectional area will be recorded by blinded researcher
Time frame: Just before anesthesia induction
Gastric Antral Cross Sectional Area (T1)
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
Time frame: Right after the SGA is placed following anesthesia induction.
Gastric Antral Cross Sectional Area (T2)
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.
Time frame: Just before the end of anesthesia, after the surgery is completed
LTS Cuff Pressure Measurement
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.
Time frame: Just after inserting a Laryngeal Tube Suction
Maximum Airway Pressure (PPeak)
The highest pressure measured by the mechanical ventilator will be recorded.
Time frame: Intraoperative
Minimum Saturation
The lowest measured saturation value.
Time frame: Intraoperative
Spasm
Incidence of spasm
Time frame: Intraoperative and/or postoperative 2 hours
The time taken for airway device placement and failed placement
The time from the moment the airway device is touched until end-tidal CO2 is detected (Second)
Time frame: Intraoperative
Postoperative Sore Throat
Incidence of sore throat assessed by direct questioning
Time frame: Postoperative 2 hours
Postoperative Nausea and Vomitting
Incidence of post operative nausea and vomitting assessed by direct questioning
Time frame: Postoperative 2 hours
Presence of blood on the supraglottic airway
Nonblinded researcher will check if there is blood contamination on the SGA after removing it.
Time frame: Just after removing the SGA
Postoperative Cough
Incidence of Cough assessed by direct questioning or physical examination
Time frame: Postoperative 2 hours
Need for nebulized medications or cool mist.
Need for nebulized medications or cool mist for spasm or cough
Time frame: Postoperative 2 hours
Plan to share: No
This study is completed, as verified in Sep 2025. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Ankara City Hospital Bilkent