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Clinical Trials/NCT02884843
NCT02884843
Unknown
Not Applicable

A Comparative Randomized Prospective Study Between the New Intubating Laryngeal Tube Suction-Disposable and the Ambu AuraGain in Blind and Fibreoptic-guided Intubation

Bnai Zion Medical Center0 sites60 target enrollmentAugust 2016

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Adverse Anesthesia Outcome
Sponsor
Bnai Zion Medical Center
Enrollment
60
Primary Endpoint
Time of blind intubation measure in seconds
Last Updated
9 years ago

Overview

Brief Summary

The study compares the intubating Laryngeal Tube Suction (iLTS-D) with the Ambu®AuraGain™ in blind and fibreoptic endotracheal intubation.

The current randomized study is designed to assess the success rate of blind and fibreoptic endotracheal intubation using i-LTS-D, in comparison with the Air-Q, i-gel® and Ambu®AuraGain™ in an airway simulator. The investigators hypothesize that the iLTS-D and the Supreme Laryngeal Mask Airway will similarly perform during spontaneous ventilation despite differences in their structural design.

Detailed Description

The intubating Laryngeal Tube Suction-Disposable (iLTS-D) (VBM Medizintechnik, Sulz, Germany) is a new updated version of the Laryngeal Tube-Suction Disposable (LTS-D). It has a ventilator channel with a 13.5mm internal diameter, which enables the passage of an Endotracheal Tube (ETT) either blindly or with fibreoptic guidance. Similarly to the LTS-D, the iLTS-D also has a separate channel for gastric tubes placement up to a size of 18 Fr. The current randomized study was designed to assess the success rate of blind and fibreoptic endotracheal intubation using iLTS-D, in comparison with the Ambu® AuraGain™ in adult patients under general anesthesia.

Registry
clinicaltrials.gov
Start Date
August 2016
End Date
July 2017
Last Updated
9 years ago
Study Type
Interventional
Study Design
Crossover
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

LUIS.GAITINI

Medical Doctor

Bnai Zion Medical Center

Eligibility Criteria

Inclusion Criteria

  • American Society Anesthesiology I and II

Exclusion Criteria

  • Difficult intubation, cervical pathology

Outcomes

Primary Outcomes

Time of blind intubation measure in seconds

Time Frame: 30 seconds

Secondary Outcomes

  • Time of Fiberoptic intubation measure in seconds(60 seconds)

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