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CompletedNCT04087135Updated Sep 12, 2019

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

An interventional study of direct laryngoscopy and videolaryngoscopy McGrath in Laryngoscope, Hemoptysis and Simulation, sponsored by Université de Montréal. Completed at 1 site in Canada. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-09-12.

Sponsored by Université de Montréal · Not applicable, Interventional, and Other

Phase
Not applicable
Study type
Interventional
Enrollment
25
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Laryngoscope
  • Hemoptysis
  • Simulation
  • Cadaver
  • Intubation; Difficult or Failed

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Keywords

  • videolaryngoscopy
  • Thiel's embalmed cadaver
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

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

Exclusion Criteria:

  • refusal to participate
04

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Single group
Masking
Single (Participant)
Enrollment
25 participants (actual)

Study arms

  • Experimental
    participant LD

    Other: direct laryngoscopy

  • Experimental
    participant VL

    Other: videolaryngoscopy McGrath

  • Experimental
    participant VLS

    Other: videolaryngoscopy McGrath with suction

Interventions

  • Otherdirect laryngoscopy

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

  • Othervideolaryngoscopy McGrath

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

  • Othervideolaryngoscopy McGrath with suction

    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.

05

What researchers measure

Primary outcomes

  1. failure of intubation on first try

    defined as the withdrawal of the laryngoscope from the mouth

    Time frame: the duration of the simulation

Secondary outcomes

  1. time to intubation

    from the insertion of the laryngoscope in the mouth to the inflation of the endotracheal cuff

    Time frame: the duration of the simulation

  2. failure in intubation

    failure to intubate after three try

    Time frame: the duration of the simulation

  3. use of suction

    document the use of suction

    Time frame: the duration of the simulation

  4. difficulty of intubation

    as describe by the participants on a Likert scale 1 to 5

    Time frame: the duration of the simulation

06

Study locations

1 site
  • Hôpital Trois-Rivières
    Trois-Rivières, Quebec H2J3T5, Canada
07

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT04087135
Lead sponsor
Université de Montréal
Collaborators
Centre d'Apprentissage des Habiletés Cliniques (CAAHC), Laboratoire d'anatomie de Trois-Rivières
Responsible party
Sponsor
First posted
Sep 12, 2019
Start date
Mar 11, 2019
Primary completion
Jun 30, 2019
Completion
Jun 30, 2019
Last update
Sep 12, 2019

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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