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

Not Applicable

• Conditions: Adverse Anesthesia Outcome
• Interventions: Device: Intubating Laryngeal Tube Suction; Device: Direct Laryngoscopy

• Registration Number: NCT02884895
• Lead Sponsor: Bnai Zion Medical Center

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.

Study Timeline

• Status Verified: 2016-08
• Study First Submitted: 2016-08-16
• Study First Submitted QC: 2016-08-30
• Study First Posted: 2016-08-31
• Last Update Submitted: 2017-01-31
• Last Update Posted: 2017-02-01
• Study Start: 2017-04
• Primary Completion: 2018-08
• Study Completion: 2018-11

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• American Society Anesthesiology class I and II

Exclusion Criteria

• Difficult airways
• Cervical pathology
• Full stomach

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Intubating laryngeal Tube Suction	Intubating Laryngeal Tube Suction	Intubating laryngeal Tube Suction
Direct Laryngoscopy	Direct Laryngoscopy	Direct Laryngoscopy

Primary Outcome Measures

Name	Time	Method
Blind tracheal intubation time measure in seconds	30 seconds

Secondary Outcome Measures

Name	Time	Method
Easy of insertion measure in numerical scale	30 seconds	Easy of insertion measure 1 to 5 Numerical scale