A Comparison of Direct Laryngoscopy With Blind Intubation Via Intubating Laryngeal Tube Suction Disposable

NCT ID: NCT02884895

Last Updated: 2017-02-01

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-04-30
• Study Completion Date: 2018-11-30

Brief Summary

Tracheal intubation is an important part of treatment for a trauma casualty. Tracheal intubation is usually achieved by a direct laryngoscope.It is an effective method but requires experience and skill demanding a long learning time.The use of the Laryngeal Tube Suction for fast control of the airway is known for many years. The Intubating Laryngeal Tube Suction is a new version of the Laryngeal Tube. The aim of this study is to examine the effectiveness of the the Intubating Laryngeal Tube Suction to achieve a definitive airway by unskilled practitioners in anesthetized patients with the head in neutral position (trauma model).

Detailed Description

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.

Tracheal intubation is usually achieved by a direct laryngoscope. This method is taught both in the training of doctors and paramedics training. Although it is an effective method requires experience and skill demanding a long learning time The use of the Laryngeal Tube Suction for fast control of the airway is known for many years. The Laryngeal Tube Suction 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 new generation of these devices allows perform blind intubation directly through a special channel. One of these devices is the Intubating Laryngeal Tube Suction

The aim of this study is to examine the effectiveness of the Intubating Laryngeal Tube Suction 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 Tube Suction 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

Adverse Anesthesia Outcome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Intubating laryngeal Tube Suction

Intubating laryngeal Tube Suction

Group Type: EXPERIMENTAL

Intubating Laryngeal Tube Suction

Intervention Type: DEVICE

Intubating Laryngeal Tube Suction Disposable

Direct Laryngoscopy

Direct Laryngoscopy

Group Type: ACTIVE_COMPARATOR

Direct Laryngoscopy

Intervention Type: DEVICE

Direct Laryngoscopy

Interventions

Intubating Laryngeal Tube Suction

Intubating Laryngeal Tube Suction Disposable

Intervention Type: DEVICE

Direct Laryngoscopy

Direct Laryngoscopy

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• American Society Anesthesiology class I and II

Exclusion Criteria

• Difficult airways
• Cervical pathology
• Full stomach

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Bnai Zion Medical Center

OTHER_GOV

Sponsor Role: lead

Responsible Party

LUIS.GAITINI

M.D.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Luis A Gaitini, M.D.

Role: PRINCIPAL_INVESTIGATOR

Bnai Zion Medical Center

Central Contacts

Luis A Gaitini, M.D.

Role: CONTACT

luis.gaitini@b-zion.org.il

# 972 4 8359346

Mostafa Somri, M.D.

Role: CONTACT

mostafa.somri@b-zion.org.il

# 972 4 8359304

Other Identifiers

BnaiZionMC-16-LG-007

Identifier Type: -

Identifier Source: org_study_id