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

Adverse Anesthesia Outcome Clinical Trial

Official title:

Establishing a Definitive Airway: Comparison of Direct Laryngoscopy With Blind Intubation Via Intubating Laryngeal Mask Airway

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02884869
• Other study ID #: BnaiZionMC-16-LG-006
• Status: Not yet recruiting
• Phase: N/A
• First received: August 16, 2016
• Last updated: August 30, 2016
• Start date: August 2016
• Est. completion date: September 2017

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
• Health authority: Israel: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

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.

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. 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: September 2017
• Est. primary completion date: August 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

Inclusion Criteria:

• American Society Anesthesiology class I and II

Exclusion Criteria:

• Difficult airway

• Cervical pathology

• Full stomach

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Adverse Anesthesia Outcome

Intervention

Device:
• Intubating Laryngeal Mask
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	Time of blind intubation measure in second	Time of blind intubation in seconds	30 seconds	Yes
Secondary	Easy to perform intubation measure in numeric scale	Easy of intubation in numerical scale from 1 to 10	30 seconds	Yes