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

N/ACompletedNCT07196137

Ankara City Hospital Bilkent101 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

101

Conditions

Laryngeal Masks Comparison Elective Surgeries Gastric Ultrasonography Gastric Insufflation

Eligibility

Sex: ALLMin age: 1 YearMax age: 12 Years

Medical Language ↔ Plain English

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.

Locations (1)

Ankara Bilkent City Hospital Department of Anesthesiology and Reanimation

Ankara, Çankaya, Turkey (Türkiye)

Outcomes

Primary Outcomes

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

Secondary Outcomes

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

Data from ClinicalTrials.gov

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