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

Adverse Anesthesia Outcome Clinical Trial

Official title:

Establishing a Definitive Airway: A Comparison of Direct Laryngoscopy With Blind Intubation Via Intubating Laryngeal Tube Suction Disposable

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02884895
• Other study ID #: BnaiZionMC-16-LG-007
• Status: Not yet recruiting
• Phase: N/A
• First received: August 16, 2016
• Last updated: January 31, 2017
• Start date: April 2017
• Est. completion date: November 2018

Study information

• Verified date: August 2016
• Source: Bnai Zion Medical Center
• Contact: Luis A Gaitini, M.D.
• Phone: # 972 4 8359346
• Email: luis.gaitini[@]b-zion.org.il
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: November 2018
• Est. primary completion date: August 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

Inclusion Criteria:

• American Society Anesthesiology class I and II

Exclusion Criteria:

• Difficult airways

• Cervical pathology

• Full stomach

Related Conditions & MeSH terms

• Adverse Anesthesia Outcome

Intervention

Device:
• Intubating Laryngeal Tube Suction
Intubating Laryngeal Tube Suction Disposable
• Direct Laryngoscopy
Direct Laryngoscopy

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bnai Zion Medical Center

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Blind tracheal intubation time measure in seconds		30 seconds
Secondary	Easy of insertion measure in numerical scale	Easy of insertion measure 1 to 5 Numerical scale	30 seconds