Comparison of Intubation With Direct Laryngoscopy or Videolaryngoscopy in an Hemoptysis Simulated Situation on Human Cadaver Embalmed With Thiel's Method
Primary Purpose
Laryngoscope, Hemoptysis, Simulation
Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
direct laryngoscopy
videolaryngoscopy McGrath
videolaryngoscopy McGrath with suction
Sponsored by
About this trial
This is an interventional other trial for Laryngoscope focused on measuring videolaryngoscopy, Thiel's embalmed cadaver
Eligibility Criteria
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
Sites / Locations
- Hôpital Trois-Rivières
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
participant LD
participant VL
participant VLS
Arm Description
Outcomes
Primary Outcome Measures
failure of intubation on first try
defined as the withdrawal of the laryngoscope from the mouth
Secondary Outcome Measures
time to intubation
from the insertion of the laryngoscope in the mouth to the inflation of the endotracheal cuff
failure in intubation
failure to intubate after three try
use of suction
document the use of suction
difficulty of intubation
as describe by the participants on a Likert scale 1 to 5
Full Information
NCT ID
NCT04087135
First Posted
September 9, 2019
Last Updated
September 9, 2019
Sponsor
Université de Montréal
Collaborators
Centre d'Apprentissage des Habiletés Cliniques (CAAHC), Laboratoire d'anatomie de Trois-Rivières
1. Study Identification
Unique Protocol Identification Number
NCT04087135
Brief Title
Comparison of Intubation With Direct Laryngoscopy or Videolaryngoscopy in an Hemoptysis Simulated Situation on Human Cadaver Embalmed With Thiel's Method
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
October 2018
Overall Recruitment Status
Completed
Study Start Date
March 11, 2019 (Actual)
Primary Completion Date
June 30, 2019 (Actual)
Study Completion Date
June 30, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Université de Montréal
Collaborators
Centre d'Apprentissage des Habiletés Cliniques (CAAHC), Laboratoire d'anatomie de Trois-Rivières
4. Oversight
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
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Laryngoscope, Hemoptysis, Simulation, Cadaver, Intubation; Difficult or Failed
Keywords
videolaryngoscopy, Thiel's embalmed cadaver
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Each participant will performe the intubation three time using the tools provided, for the same simulation situation: (a) direct laryngoscopy, (b) videolaryngoscopy McGrath and (c) videolaryngoscopy McGrath with suction.
Masking
Participant
Allocation
Randomized
Enrollment
25 (Actual)
8. Arms, Groups, and Interventions
Arm Title
participant LD
Arm Type
Experimental
Arm Title
participant VL
Arm Type
Experimental
Arm Title
participant VLS
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
direct laryngoscopy
Intervention Description
Participants will intubate the hemoptysis cadaver model in simulation with direct laryngoscopy MacIntosh blade.
Intervention Type
Other
Intervention Name(s)
videolaryngoscopy McGrath
Intervention Description
Participants will intubate the hemoptysis cadaver model in simulation with videolaryngoscopy using McGrath and the short curved blade (XBlade)
Intervention Type
Other
Intervention Name(s)
videolaryngoscopy McGrath with suction
Intervention Description
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.
Primary Outcome Measure Information:
Title
failure of intubation on first try
Description
defined as the withdrawal of the laryngoscope from the mouth
Time Frame
the duration of the simulation
Secondary Outcome Measure Information:
Title
time to intubation
Description
from the insertion of the laryngoscope in the mouth to the inflation of the endotracheal cuff
Time Frame
the duration of the simulation
Title
failure in intubation
Description
failure to intubate after three try
Time Frame
the duration of the simulation
Title
use of suction
Description
document the use of suction
Time Frame
the duration of the simulation
Title
difficulty of intubation
Description
as describe by the participants on a Likert scale 1 to 5
Time Frame
the duration of the simulation
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
Hôpital Trois-Rivières
City
Trois-Rivières
State/Province
Quebec
ZIP/Postal Code
H2J3T5
Country
Canada
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Comparison of Intubation With Direct Laryngoscopy or Videolaryngoscopy in an Hemoptysis Simulated Situation on Human Cadaver Embalmed With Thiel's Method
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