NCT04087135

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 11, 2019

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2019

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

September 9, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 12, 2019

Completed
Last Updated

September 12, 2019

Status Verified

October 1, 2018

Enrollment Period

4 months

First QC Date

September 9, 2019

Last Update Submit

September 9, 2019

Conditions

Keywords

videolaryngoscopyThiel's embalmed cadaver

Outcome Measures

Primary Outcomes (1)

  • failure of intubation on first try

    defined as the withdrawal of the laryngoscope from the mouth

    the duration of the simulation

Secondary Outcomes (4)

  • time to intubation

    the duration of the simulation

  • failure in intubation

    the duration of the simulation

  • use of suction

    the duration of the simulation

  • difficulty of intubation

    the duration of the simulation

Study Arms (3)

participant LD

EXPERIMENTAL
Other: direct laryngoscopy

participant VL

EXPERIMENTAL
Other: videolaryngoscopy McGrath

participant VLS

EXPERIMENTAL
Other: videolaryngoscopy McGrath with suction

Interventions

Participants will intubate the hemoptysis cadaver model in simulation with direct laryngoscopy MacIntosh blade.

participant LD

Participants will intubate the hemoptysis cadaver model in simulation with videolaryngoscopy using McGrath and the short curved blade (XBlade)

participant VL

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.

participant VLS

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • refusal to participate

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hôpital Trois-Rivières

Trois-Rivières, Quebec, H2J3T5, Canada

Location

MeSH Terms

Conditions

HemoptysisCadaver

Interventions

Suction

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract DiseasesHemorrhagePathologic ProcessesPathological Conditions, Signs and SymptomsSigns and Symptoms, RespiratorySigns and SymptomsDeath

Intervention Hierarchy (Ancestors)

DrainageSurgical Procedures, Operative

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
OTHER
Intervention Model
SINGLE GROUP
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 9, 2019

First Posted

September 12, 2019

Study Start

March 11, 2019

Primary Completion

June 30, 2019

Study Completion

June 30, 2019

Last Updated

September 12, 2019

Record last verified: 2018-10

Locations