Comparison of Intubation With Direct Laryngoscopy or Videolaryngoscopy in an Hemoptysis Simulated Situation on Human Cadaver Embalmed With Thiel's Method

September 9, 2019 updated by: Université de Montréal

Comparison of the Success Rate of Intubation With Direct Laryngoscopy or Videolaryngoscopy in an Hemoptysis Simulated Situation on Human Cadaver Embalmed With Thiel's Method

Our study first aims to develope a realistic cadaver model of hemoptysis based on Thiel's embalmed cadavers. Secondly, participants will intubate the hemoptysis cadaver model with (a) the direct laryngoscopy with MacIntosh blade, (b) the videolaryngoscopy with McGrath XBlade and (c) the videolaryngoscopy with McGrath XBlade and a suction advance before the optic of the camera. We hypothesis that, in simulated hemoptysis on the Thiel's embalmed cadaver, the rate of failed intubation at first try will be different depending on the laryngoscope used.

Study Overview

Detailed Description

For the simulation of hemoptysis, we will need to use the Thiel's embalmed cadaver, who's realism is established, create a synthetic form of blood resembling real blood by its viscosity and color for the simulation and elaborate the dynamic interface of the simulation of hemoptysis. The quantity and way of administration of the blood through the trachea will be tested to obtain a realistic hemoptysis as seen in supraglottic.

For the simulation, we will compare the efficiency of intubation, judged by the failure rate of intubation on first try, for (a) the direct laryngoscopy with MacIntosh blade, (b) the videolaryngoscopy with McGrath XBlade and (c) the videolaryngoscopy with McGrath XBlade with the suction advanced before the camera. We will also measure the time to intubation, the failure rate of intubation, the suction use and the difficulty of intubation as reported by the participants.

Study Type

Interventional

Enrollment (Actual)

25

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 Locations

    • Quebec
      • Trois-Rivières, Quebec, Canada, H2J3T5
        • Hôpital Trois-Rivières

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

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • all wiling doctors and medical residents in the departments of anesthesiology, emergency medicine and intensive care
  • experience with the technique of intubation using videolaryngoscopy and direct laryngoscopy.

Exclusion Criteria:

  • refusal to participate

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: Other
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: participant LD
Participants will intubate the hemoptysis cadaver model in simulation with direct laryngoscopy MacIntosh blade.
Experimental: participant VL
Participants will intubate the hemoptysis cadaver model in simulation with videolaryngoscopy using McGrath and the short curved blade (XBlade)
Experimental: participant VLS
Participants will intubate the hemoptysis cadaver model in simulation with videolaryngoscopy using McGrath and the short curved blade (XBlade) and a suction they will advanced directly before the optic of the camera.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
failure of intubation on first try
Time Frame: the duration of the simulation
defined as the withdrawal of the laryngoscope from the mouth
the duration of the simulation

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
time to intubation
Time Frame: the duration of the simulation
from the insertion of the laryngoscope in the mouth to the inflation of the endotracheal cuff
the duration of the simulation
failure in intubation
Time Frame: the duration of the simulation
failure to intubate after three try
the duration of the simulation
use of suction
Time Frame: the duration of the simulation
document the use of suction
the duration of the simulation
difficulty of intubation
Time Frame: the duration of the simulation
as describe by the participants on a Likert scale 1 to 5
the duration of the simulation

Collaborators and Investigators

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

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 (Actual)

March 11, 2019

Primary Completion (Actual)

June 30, 2019

Study Completion (Actual)

June 30, 2019

Study Registration Dates

First Submitted

September 9, 2019

First Submitted That Met QC Criteria

September 9, 2019

First Posted (Actual)

September 12, 2019

Study Record Updates

Last Update Posted (Actual)

September 12, 2019

Last Update Submitted That Met QC Criteria

September 9, 2019

Last Verified

October 1, 2018

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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.

Clinical Trials on Simulation

Clinical Trials on direct laryngoscopy

3
Subscribe