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The New Laryngeal Tube Suction-Disposable for Childrens

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ClinicalTrials.gov Identifier: NCT02866890
Recruitment Status : Unknown
Verified August 2016 by LUIS.GAITINI, Bnai Zion Medical Center.
Recruitment status was:  Not yet recruiting
First Posted : August 15, 2016
Last Update Posted : August 15, 2016
Sponsor:
Information provided by (Responsible Party):
LUIS.GAITINI, 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.

Condition or disease Intervention/treatment Phase
Adverse Anesthesia Outcome Device: Laryngeal Tube Suction Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: The New Laryngeal Tube Suction-Disposable for Childrens. An Observational Study
Study Start Date : December 2016
Estimated Primary Completion Date : January 2017
Estimated Study Completion Date : October 2017

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 Name: 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 Name: 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 Name: VBM Medical, Sulz, Germany




Primary Outcome Measures :
  1. Seal pressure in cm H2O [ Time Frame: 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 :
  1. Time of insertion in seconds [ Time Frame: 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.


Other Outcome Measures:
  1. Easy of insertion using a five-point Likert Scale [ Time Frame: One minute ]
    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.



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Ages Eligible for Study:   1 Year to 10 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02866890


Contacts
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Contact: Luis A Gaitini, M.D. # 972 4 8359361 luis.gaitini@b-zion.org.il

Sponsors and Collaborators
Bnai Zion Medical Center
Investigators
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Principal Investigator: Luis A Gaitini, M.D. Bnai Zion Medical Center

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Responsible Party: LUIS.GAITINI, M.D., Bnai Zion Medical Center
ClinicalTrials.gov Identifier: NCT02866890     History of Changes
Other Study ID Numbers: BnaiZionMC-16-LG-003
First Posted: August 15, 2016    Key Record Dates
Last Update Posted: August 15, 2016
Last Verified: August 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

Keywords provided by LUIS.GAITINI, Bnai Zion Medical Center:
Laryngeal Tube Suction
seal pressure
mechanical ventilation