The New Laryngeal Tube Suction-Disposable for Childrens

Not Applicable

• Conditions: Adverse Anesthesia Outcome
• Interventions: Device: Laryngeal Tube Suction

• Registration Number: NCT02866890
• Lead Sponsor: Bnai Zion Medical Center

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2016-07-25
• Status Verified: 2016-08
• Study First Submitted QC: 2016-08-10
• Last Update Submitted: 2016-08-10
• Study First Posted: 2016-08-15
• Last Update Posted: 2016-08-15
• Study Start: 2016-12
• Primary Completion: 2017-01
• Study Completion: 2017-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 90

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Laryngeal Tube Suction size 2	Laryngeal Tube Suction	Measurement of leak pressure
Laryngeal Tube Suction size 1	Laryngeal Tube Suction	Measurement of leak pressure
Laryngeal Tube Suction size 2.5	Laryngeal Tube Suction	Measurement of leak pressure

Primary Outcome Measures

Name	Time	Method
Seal pressure in cm H2O	one minute	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

Secondary Outcome Measures

Name	Time	Method
Time of insertion in seconds	one minute	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.