The New Laryngeal Tube Suction-Disposable for Childrens

Adverse Anesthesia Outcome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02866890
• Other study ID #: BnaiZionMC-16-LG-003
• Status: Not yet recruiting
• Phase: N/A
• First received: July 25, 2016
• Last updated: August 10, 2016
• Start date: December 2016
• Est. completion date: October 2017

Study information

• Verified date: August 2016
• Source: Bnai Zion Medical Center
• Contact: Luis A Gaitini, M.D.
• Phone: # 972 4 8359361
• Email: luis.gaitini[@]b-zion.org.il
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 90
• Est. completion date: October 2017
• Est. primary completion date: January 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 1 Year to 10 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Adverse Anesthesia Outcome

Intervention

Device:
• Laryngeal Tube Suction
Laryngeal Tube Suction Measurement of leak pressure

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bnai Zion Medical Center

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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	Yes
Primary	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	Yes
Secondary	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	Yes