The New Laryngeal Tube Suction-Disposable for Childrens

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

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.

Study Overview

• Status: Unknown
• Conditions: Adverse Anesthesia Outcome
• Intervention / Treatment: Device: Laryngeal Tube Suction

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 Type: Interventional
• Enrollment (Anticipated): 90
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Luis A Gaitini, M.D.; Phone Number: # 972 4 8359361; Email: luis.gaitini@b-zion.org.il

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year to 10 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Laryngeal Tube Suction size 1; Measurement of leak pressure	Device: Laryngeal Tube Suction; Laryngeal Tube Suction Measurement of leak pressure; Other Names: VBM Medical, Sulz, Germany
Experimental: Laryngeal Tube Suction size 2; Measurement of leak pressure	Device: Laryngeal Tube Suction; Laryngeal Tube Suction Measurement of leak pressure; Other Names: VBM Medical, Sulz, Germany
Experimental: Laryngeal Tube Suction size 2.5; Measurement of leak pressure	Device: Laryngeal Tube Suction; Laryngeal Tube Suction Measurement of leak pressure; Other Names: VBM Medical, Sulz, Germany

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Easy of insertion using a five-point Likert Scale	Investigators were asked to complete a questionnaire independently and anonymously to record the 'ease-of-use' of the LTS-D. Insertion of the devices was classified as 1= easy, 2= moderate, 3= difficult and 4=impossible.	One minute

Collaborators and Investigators

• Sponsor: Bnai Zion Medical Center

Study record dates

Study Major Dates

• Study Start: December 1, 2016
• Primary Completion (Anticipated): January 1, 2017
• Study Completion (Anticipated): October 1, 2017

Study Registration Dates

• First Submitted: July 25, 2016
• First Submitted That Met QC Criteria: August 10, 2016
• First Posted (Estimate): August 15, 2016

Study Record Updates

• Last Update Posted (Estimate): August 15, 2016
• Last Update Submitted That Met QC Criteria: August 10, 2016
• Last Verified: August 1, 2016

More Information

Terms related to this study

• Keywords: mechanical ventilation; seal pressure; Laryngeal Tube Suction
• Other Study ID Numbers: BnaiZionMC-16-LG-003

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES