The New Laryngeal Tube Suction-Disposable for Childrens

Bnai Zion Medical Center

Status: Unknown

Conditions: Adverse Anesthesia Outcome

Treatments: Device: Laryngeal Tube Suction

Study type: Interventional

Funder types: Other

Identifiers

NCT02866890

BnaiZionMC-16-LG-003

Details and patient eligibility

About

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.

Full 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.

Enrollment: 90 estimated patients

Sex: All

Ages: 1 to 10 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Single Blind

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90 participants in 3 patient groups

Laryngeal Tube Suction size 1

Experimental group

Description:

Measurement of leak pressure

Treatment:

Device: Laryngeal Tube Suction

Laryngeal Tube Suction size 2

Experimental group

Description:

Measurement of leak pressure

Treatment:

Device: Laryngeal Tube Suction

Laryngeal Tube Suction size 2.5

Experimental group

Description:

Measurement of leak pressure

Treatment:

Device: Laryngeal Tube Suction