NCT02866890

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2016

Shorter than P25 for not_applicable

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 25, 2016

Completed
21 days until next milestone

First Posted

Study publicly available on registry

August 15, 2016

Completed
4 months until next milestone

Study Start

First participant enrolled

December 1, 2016

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2017

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2017

Completed
Last Updated

August 15, 2016

Status Verified

August 1, 2016

Enrollment Period

1 month

First QC Date

July 25, 2016

Last Update Submit

August 10, 2016

Conditions

Adverse Anesthesia Outcome

Keywords

Laryngeal Tube Suctionseal pressuremechanical ventilation

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Time of insertion in seconds

    one minute

Other Outcomes (1)

  • Easy of insertion using a five-point Likert Scale

    One minute

Study Arms (3)

Laryngeal Tube Suction size 1

EXPERIMENTAL

Measurement of leak pressure

Device: Laryngeal Tube Suction

Laryngeal Tube Suction size 2

EXPERIMENTAL

Measurement of leak pressure

Device: Laryngeal Tube Suction

Laryngeal Tube Suction size 2.5

EXPERIMENTAL

Measurement of leak pressure

Device: Laryngeal Tube Suction

Interventions

Laryngeal Tube SuctionDEVICE

Laryngeal Tube Suction Measurement of leak pressure

Also known as: VBM Medical, Sulz, Germany
Laryngeal Tube Suction size 1Laryngeal Tube Suction size 2Laryngeal Tube Suction size 2.5

Eligibility Criteria

Age1 Year - 10 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Officials

  • Luis A Gaitini, M.D.

    Bnai Zion Medical Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Luis A Gaitini, M.D.

CONTACT

# 972 4 8359361luis.gaitini@b-zion.org.il

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
M.D.

Study Record Dates

First Submitted

July 25, 2016

First Posted

August 15, 2016

Study Start

December 1, 2016

Primary Completion

January 1, 2017

Study Completion

October 1, 2017

Last Updated

August 15, 2016

Record last verified: 2016-08

Data Sharing

IPD Sharing
Will share