A Study Between the Laryngeal Tube Suction-Disposable and the Ambu AuraGain in Pediatric Patients

Study Overview
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Brief Summary
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The study compared the Laryngeal Tube Suction Disposable (LTS-D) with the Disposable Laryngeal Mask Ambu® AuraGain™ (DLMA AG) during general anesthesia in pediatric patients. The investigators hypothesized that the LTS-D and the DLMA AG performed similarly during mechanical ventilation despite differences in their structural design.

Detailed Description
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The Laryngeal Tube Suction-Disposable (LTS-D, (VBM Medizintechnik GmbH, Sulz, Germany), is a second generation single-use supraglottic airway devices (SADs) with gastric access, for airway management in spontaneously and mechanically ventilated patients undergoing general anesthesia. The AuraGain is a second generation laryngeal mask, satisfying airway management needs by integrating gastric access and ventilation capability in an anatomically curved single-use device that facilitates rapid establishment of a safe airway. The two devices have now pediatric sizes. To date, there is no published data comparing the LTS-D and the DLMA AG during mechanical ventilation in pediatric patients. The investigators hypothesized that the LTS-D and the DLMA AG perform similarly during mechanical ventilation despite differences in their structural design. The chief aim of this prospective randomized study was to compare the LTS-D and the DLMA AG with respect to: time to achieve an effective airway, ease of insertion, need for interventions to achieve an effective airway, cuff seal (leak) pressure at an intracuff pressure of 60 cm H2O, ventilatory variables during mechanical ventilation, fiberoptic score, gastric tube insertion and adverse perioperative events.

Official Title
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A Comparative Randomized Prospective Study Between the New Laryngeal Tube Suction-Disposable and the Ambu AuraGain in Pediatric Patients

Conditions
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Adverse Anesthesia Outcome

Intervention / Treatment
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* Device: Laryngeal Tube Suction Disposable
* Device: Laryngeal Mask Airway AuraGain


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Pediatric patients, American Society of Anesthesiologist (ASA) physical status I and II weighing 30 to 10 kg, posted for abdominal surgery under general anesthesia. Exclusion Criteria: Infants with active respiratory tract infection anticipated and known difficult airway, lung disease requiring high positive end expiratory pressure, and active gastrointestinal reflux will be excluded.

Ages Eligible for Study
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Minimum Age: 1 Year
Maximum Age: 10 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Laryngeal Tube Suction Disposable<br>Laryngeal Tube Suction Disposable for ventilation | Device: Laryngeal Tube Suction Disposable<br>* Device for ventilation<br>|
| Experimental: Laryngeal Mask Airway AuraGain<br>Laryngeal Mask Airway AuraGain for oxygenation and ventilation | Device: Laryngeal Mask Airway AuraGain<br>* Ventilation device<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Leak pressure measure in cm H2O |  | 60 seconds | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to insertion a device in seconds |  | 60 seconds | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Laryngeal Tube Suction Ambu AuraGain Leak Pressure