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The New Laryngeal Tube Suction-Disposable for Childrens

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02866890
Enrollment
90
Registered
2016-08-15
Start date
2016-12-31
Completion date
2017-10-31
Last updated
2016-08-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Adverse Anesthesia Outcome

Keywords

Laryngeal Tube Suction, seal pressure, mechanical ventilation

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.

Interventions

DEVICELaryngeal Tube Suction

Laryngeal Tube Suction Measurement of leak pressure

Sponsors

Bnai Zion Medical Center
Lead SponsorOTHER_GOV

Study design

Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)

Eligibility

Sex/Gender
ALL
Age
1 Years to 10 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Seal pressure in cm H2Oone minuteWe 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

MeasureTime frameDescription
Time of insertion in secondsone minuteWas 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.

Other

MeasureTime frameDescription
Easy of insertion using a five-point Likert ScaleOne minuteInvestigators 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.

Contacts

Primary ContactLuis A Gaitini, M.D.
luis.gaitini@b-zion.org.il# 972 4 8359361

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026