Comparison of Intubation With Direct Laryngoscopy or Vide... | NCT04087135

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

NCT04087135

Sponsor

Université de Montréal

Status

Completed

Last Update Posted

Sep 12, 2019Actual

Enrollment

25Actual

Phase

Not Applicable

Conditions

Laryngoscope
Hemoptysis
Simulation
Cadaver
Intubation; Difficult or Failed

Interventions

direct laryngoscopy
videolaryngoscopy McGrath
videolaryngoscopy McGrath with suction

Countries

Canada

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Status Module

Record Verification Date

Oct 2018

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 11, 2019Actual

Primary Completion Date

Jun 30, 2019Actual

Completion Date

Jun 30, 2019Actual

First Submitted Date

Sep 9, 2019

First Submission Date that Met QC Criteria

Sep 9, 2019

First Posted Date

Sep 12, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 9, 2019

Last Update Posted Date

Sep 12, 2019Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Sponsor

Lead Sponsor

Université de MontréalOTHER

Collaborators

Name	Class
Centre d'Apprentissage des Habiletés Cliniques (CAAHC)	UNKNOWN
Laboratoire d'anatomie de Trois-Rivières	UNKNOWN

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

25Actual

Arms/Interventions Module

Arm Groups

Label	Type	Intervention Names
participant LD	Experimental	Other: direct laryngoscopy
participant VL	Experimental	Other: videolaryngoscopy McGrath
participant VLS	Experimental	Other: videolaryngoscopy McGrath with suction

Interventions

Name	Type	Description	Arm Group Labels	Other Names
direct laryngoscopy	Other	Participants will intubate the hemoptysis cadaver model in simulation with direct laryngoscopy MacIntosh blade.	participant LD

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
time to intubation	from the insertion of the laryngoscope in the mouth to the inflation of the endotracheal cuff	the duration of the simulation
failure in intubation	failure to intubate after three try

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hôpital Trois-Rivières		Trois-Rivières	Quebec	H2J3T5	Canada

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Derived Section

Miscellaneous Info Module

Version Holder

Jul 10, 2026

Removed Countries

Not provided

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

MeSH Terms

Intervention Browse Module

MeSH Terms

Intervention 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.

ID	Term
D006469	Hemoptysis
D002102	Cadaver

Ancestor Terms

ID	Term
D008171	Lung Diseases
D012140	Respiratory Tract Diseases
D006470	Hemorrhage
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms
D012818	Signs and Symptoms, Respiratory
D012816	Signs and Symptoms
D003643	Death

ID	Term
D004322	Drainage
D013514	Surgical Procedures, Operative