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Comparison of Direct Laryngoscopy With Blind Intubation Via Intubating Laryngeal Mask Airway

NCT ID: NCT02884869

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

2017-09-30

Brief Summary

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Control the airways by endotracheal intubation is an important part of treatment for a trauma casualty. The use of the Laryngeal Mask Airway for fast control of the airway is known for many years. The aim of this study is to examine the effectiveness of the Intubating Laryngeal Mask Airway to achieve a definitive airway by unskilled practitioners.

The hypothesis is that definitive airway obtaining with Intubating Laryngeal Mask Airway will be more success and faster compared to the standard way of direct laryngoscope.

Detailed Description

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Control the airways and respiration are an important part of treatment for a trauma casualty. Tracheal intubation an action that allows the insertion of a tube through the vocal cords and fixation by the balloon inflation is a definitive airway. The use of the Laryngeal Mask Airway for fast control of the airway is known for many years. The Laryngeal Mask Airway and others similar devices are known as Supraglottic Airway Devices and are inserted blind in the oropharynx and allow a fast oxygenation and ventilation of the patients.The aim of this study is to examine the effectiveness of the Laryngeal Mask Airway to achieve a definitive airway by unskilled practitioners in anesthetized patients with the head in neutral position (trauma model)

The hypothesis is that definitive airway obtaining with Intubating Laryngeal Mask Airway will be more success and faster compared to the standard way of direct laryngoscope. If the hypothesis is proven, this research will be very important implications for the management of the airway describing pre-hospital and in particular military scenarios.

Conditions

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Adverse Anesthesia Outcome

Keywords

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Blind intubation, Laryngeal Mask Airway

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

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Intubating laryngeal Mask

Intubating laryngeal Mask

Group Type EXPERIMENTAL

Intubating Laryngeal Mask

Intervention Type DEVICE

Direct laryngoscopy

Direct laryngoscopy

Intubating laryngeal Mask

Group Type ACTIVE_COMPARATOR

Intubating Laryngeal Mask

Intervention Type DEVICE

Direct laryngoscopy

Interventions

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Intubating Laryngeal Mask

Direct laryngoscopy

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* American Society Anesthesiology class I and II

Exclusion Criteria

* Difficult airway
* Cervical pathology
* Full stomach
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

M.D.

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 8359346

Email: [email protected]

Other Identifiers

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BnaiZionMC-16-LG-006

Identifier Type: -

Identifier Source: org_study_id