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Completed

NCT Number: NCT07196137

Comparing the Effect of LTS and Air-Q sp3G LMA Use on Gastric Insufflation Using Ultrasound

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.

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Key information

Age range

1 year–12 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Ankara Bilkent City Hospital Department of Anesthesiology and Reanimation

Ankara, Çankaya, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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.

Treatment and study plan

Primary outcomes

  1. Gastric Antral Cross Sectional Area (T0)

    Time frame: 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

  2. Gastric Antral Cross Sectional Area (T1)

    Time frame: 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

  3. Gastric Antral Cross Sectional Area (T2)

    Time frame: 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.

Secondary outcomes

  1. LTS Cuff Pressure Measurement

    Time frame: 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.

  2. Maximum Airway Pressure (PPeak)

    Time frame: Intraoperative

    The highest pressure measured by the mechanical ventilator will be recorded.

  3. Minimum Saturation

    Time frame: Intraoperative

    The lowest measured saturation value.

  4. Spasm

    Time frame: Intraoperative and/or postoperative 2 hours

    Incidence of spasm

  5. The time taken for airway device placement and failed placement

    Time frame: Intraoperative

    The time from the moment the airway device is touched until end-tidal CO2 is detected (Second)

  6. Postoperative Sore Throat

    Time frame: Postoperative 2 hours

    Incidence of sore throat assessed by direct questioning

  7. Postoperative Nausea and Vomitting

    Time frame: Postoperative 2 hours

    Incidence of post operative nausea and vomitting assessed by direct questioning

  8. Presence of blood on the supraglottic airway

    Time frame: Just after removing the SGA

    Nonblinded researcher will check if there is blood contamination on the SGA after removing it.

  9. Postoperative Cough

    Time frame: Postoperative 2 hours

    Incidence of Cough assessed by direct questioning or physical examination

  10. Need for nebulized medications or cool mist.

    Time frame: Postoperative 2 hours

    Need for nebulized medications or cool mist for spasm or cough

Sponsors and collaborators

Lead sponsor

Ankara City Hospital Bilkent

Other

Registry information

Official study title

Comparing the Effect of Laryngeal Tube Suction (LTS) and Air-Q sp3G Laryngeal Mask Airway (LMA) Use on Gastric Insufflation and Volume Using Ultrasound

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Sep 29, 2025
Registry last updated
May 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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