The New Laryngeal Tube Suction-Disposable for Childrens

Study Overview
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Brief Summary
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The Laryngeal Tube Suction Disposable( LTS-D) has recently undergone considerable structural changes in design. As these changes may influence the performance of the LTS-D relative to the old LTS-D version the investigator decided to check the new LTS-D in the pediatric version The investigator hypothesized that the LTS-D perform clinically well during general anesthesia with controlled ventilation.

Detailed Description
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The LTS-D, is a second generation supraglottic airway device, made from the medical polyvinyl chloride introduce in 2005. It is used for maintaining the airway during spontaneous and controlled ventilation during general anesthesia . It has been advocated for prehospital emergency airway management and serves as a useful tool during failed intubations The LTS-D has recently undergone considerable changes in design based on clinical studies and investigators feedback. The new LTS-D is available to adult and pediatric sizes.For childrens the devices is presented in the size 3 for patients of < 155 cm (> 30 Kg.), the size 2.5 for patients 125-150cm. (20-30 Kg.), the size 2 for patients of 12-25 Kg, the size 1 for patients of 5-12 Kg and the size 0 for patients < 5 Kg. As these changes may influence the performance of the LTS-D relative to the old LTS-D version the investigator decided to check the new LTS-D in the pediatric version. The investigator hypothesized that the LTS-D perform clinically well during general anesthesia with controlled ventilation.

Official Title
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The New Laryngeal Tube Suction-Disposable for Childrens. An Observational Study

Conditions
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Adverse Anesthesia Outcome

Intervention / Treatment
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* Device: Laryngeal Tube Suction


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria:Pediatric patients, ASA I and II, normal airway, for minor elective surgery Exclusion Criteria: Weigth <10Kg or > 30 Kg, known difficult airway, active esophagial reflux

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: Single Group Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Laryngeal Tube Suction size 1<br>Measurement of leak pressure | Device: Laryngeal Tube Suction<br>* Laryngeal Tube Suction Measurement of leak pressure<br>* Other names: VBM Medical, Sulz, Germany;|
| Experimental: Laryngeal Tube Suction size 2<br>Measurement of leak pressure | Device: Laryngeal Tube Suction<br>* Laryngeal Tube Suction Measurement of leak pressure<br>* Other names: VBM Medical, Sulz, Germany;|
| Experimental: Laryngeal Tube Suction size 2.5<br>Measurement of leak pressure | Device: Laryngeal Tube Suction<br>* Laryngeal Tube Suction Measurement of leak pressure<br>* Other names: VBM Medical, Sulz, Germany;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Seal pressure in cm H2O | We will measure the seal leak pressure at 60 cm H2O intracuff pressure and the minimal pressure of the cuff to performed effective volume controlled ventilation | one minute | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time of insertion in seconds | Was measured as the time after the anesthesiologist removed the facemask until the square-wave capnograph tracing was observed after insertion of the LTS-D. Two attempts at insertion were permitted. | one minute | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Laryngeal Tube Suction, seal pressure, mechanical ventilation