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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

101 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-09-29

Study Completion Date

2026-01-29

Brief Summary

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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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Detailed Description

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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.

Conditions

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Laryngeal Masks Comparison Elective Surgeries Gastric Ultrasonography Gastric Insufflation

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Study Groups

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AIRQ

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.

No interventions assigned to this group

LTS

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.

No interventions assigned to this group

Eligibility Criteria

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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.

Minimum Eligible Age

1 Year

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No