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

August 30, 2016 updated by: LUIS.GAITINI, Bnai Zion Medical Center

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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. 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.

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • American Society Anesthesiology class I and II

Exclusion Criteria:

  • Difficult airway
  • Cervical pathology
  • Full stomach

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intubating laryngeal Mask
Device: Intubating Laryngeal Mask
Direct laryngoscopy
Active Comparator: Direct laryngoscopy
Intubating laryngeal Mask
Device: Intubating Laryngeal Mask
Direct laryngoscopy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time of blind intubation measure in second
Time Frame: 30 seconds
Time of blind intubation in seconds
30 seconds

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Easy to perform intubation measure in numeric scale
Time Frame: 30 seconds
Easy of intubation in numerical scale from 1 to 10
30 seconds

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bnai Zion Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2016

Primary Completion (Anticipated)

August 1, 2016

Study Completion (Anticipated)

September 1, 2017

Study Registration Dates

First Submitted

August 16, 2016

First Submitted That Met QC Criteria

August 30, 2016

First Posted (Estimate)

August 31, 2016

Study Record Updates

Last Update Posted (Estimate)

August 31, 2016

Last Update Submitted That Met QC Criteria

August 30, 2016

Last Verified

August 1, 2016

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • BnaiZionMC-16-LG-006

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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