The New Intubating Laryngeal Tube Suction-Disposable

NCT ID: NCT02884843

Last Updated: 2016-08-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-08-31

Study Completion Date

2017-07-31

Brief Summary

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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

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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.

Conditions

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Adverse Anesthesia Outcome

Keywords

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Laryngeal Tube blind intubation fiberoptic

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Investigators

Study Groups

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Intubation laryngeal Tube Suction

Intubation laryngeal Tube Suction Disposable

Group Type ACTIVE_COMPARATOR

Intubation laryngeal Tube Suction

Intervention Type DEVICE

Intubation laryngeal Tube Suction

AuraGain Laryngeal Mask

AuraGain Laryngeal Mask

Group Type ACTIVE_COMPARATOR

AuraGain Laryngeal Mask

Intervention Type DEVICE

AuraGain Laryngeal Mask

Interventions

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Intubation laryngeal Tube Suction

Intubation laryngeal Tube Suction

Intervention Type DEVICE

AuraGain Laryngeal Mask

AuraGain Laryngeal Mask

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* American Society Anesthesiology I and II

Exclusion Criteria

* Difficult intubation, cervical pathology
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bnai Zion Medical Center

OTHER_GOV

Sponsor Role lead

Responsible Party

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LUIS.GAITINI

Medical Doctor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Luis a Gaitini, M.D.

Role: PRINCIPAL_INVESTIGATOR

Bnai Zion Medical Center

Central Contacts

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Luis A Gaitini, M.D.

Role: CONTACT

Phone: # 972 4 8359346

Email: [email protected]

Mostafa Somri, M.D.

Role: CONTACT

Phone: # 972 4 8359304

Email: [email protected]

Other Identifiers

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BnaiZionMC-16-LG-004

Identifier Type: -

Identifier Source: org_study_id