The New Laryngeal Tube Suction-Disposable for Childrens

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

UNKNOWN

Clinical Phase

NA

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-12-31

Study Completion Date

2017-10-31

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.

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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.

Conditions

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Adverse Anesthesia Outcome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

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Laryngeal Tube Suction size 1

Measurement of leak pressure

Group Type EXPERIMENTAL

Laryngeal Tube Suction

Intervention Type DEVICE

Laryngeal Tube Suction Measurement of leak pressure

Laryngeal Tube Suction size 2

Measurement of leak pressure

Group Type EXPERIMENTAL

Laryngeal Tube Suction

Intervention Type DEVICE

Laryngeal Tube Suction Measurement of leak pressure

Laryngeal Tube Suction size 2.5

Measurement of leak pressure

Group Type EXPERIMENTAL

Laryngeal Tube Suction

Intervention Type DEVICE

Laryngeal Tube Suction Measurement of leak pressure

Interventions

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Laryngeal Tube Suction

Laryngeal Tube Suction Measurement of leak pressure

Intervention Type DEVICE

Other Intervention Names

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VBM Medical, Sulz, Germany

Eligibility Criteria

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Inclusion Criteria

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

Minimum Eligible Age

1 Year

Maximum Eligible Age

10 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No