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A Novel Method of Lung Isolation Compared With Standard Methods in a Model of Massive Pulmonary Hemorrhage (BloodyBlocker)

Primary Purpose

Pulmonary Hemorrhage

Status
Unknown status
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Bronchial Blocker
Sponsored by
University of British Columbia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional device feasibility trial for Pulmonary Hemorrhage focused on measuring simulation, anesthesia

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Practicing anesthesiologists
  • Anesthesia fellows

Exclusion Criteria:

  • Those who don't want to participate

Sites / Locations

  • BC Children's Hospital - Department of AnesthesiaRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Study trial

Arm Description

All participants will perform pulmonary blockade on an intubating manikin using 4 different methods: Endobronchial intubation with an endotracheal tube; Bronchial blocker attached to the outside of an endotracheal tube; Double lumen endotracheal tube; and Intraluminal placement of bronchial blocker.

Outcomes

Primary Outcome Measures

Total time to successful lung isolation.
Total time from start of direct laryngoscopy to establishment of lung isolation confirmed by one lung ventilation.

Secondary Outcome Measures

Time to successful intubation
Time from the start of direct laryngoscopy to successful intubation confirmed by ventilation of both lungs.
Time to successful method placement
Time from successful intubation to establishment of lung isolation.
Model utility
Responses on post-study questionnaire for future utility of the model in simulations, based on the Lung Isolation Techniques Simulation Training Evaluation Questionnaire (LITSTEQ) developed by Failor and colleagues (2014) https://doi.org/10.1053/j.jvca.2013.07.015, modified to specify training for massive pulmonary hemorrhage. Graded on a Likert scale of 1-5; 1 - Strongly disagree, 2 - Disagree, 3 - Neutral, 4 - Agree, 5 - Strongly Agree. Higher scores relate to a more positive outcome in assessing the utility of using the simulation model for massive pulmonary hemorrhage training.

Full Information

First Posted
July 30, 2021
Last Updated
September 16, 2021
Sponsor
University of British Columbia
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1. Study Identification

Unique Protocol Identification Number
NCT05001607
Brief Title
A Novel Method of Lung Isolation Compared With Standard Methods in a Model of Massive Pulmonary Hemorrhage
Acronym
BloodyBlocker
Official Title
A Novel Method of Lung Isolation Compared With Standard Methods in a Model of Massive Pulmonary Hemorrhage.
Study Type
Interventional

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Unknown status
Study Start Date
September 16, 2021 (Actual)
Primary Completion Date
July 2022 (Anticipated)
Study Completion Date
October 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of British Columbia

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Dr. Purdy has developed a novel bronchial blocker device that has multiple applications. In this project, a simulation model of massive pulmonary hemorrhage in an adolescent intubating manikin will be used to compare the novel method against 3 published methods of lung isolation.
Detailed Description
Purpose: To compare a novel airway device in a realistic adolescent airway model of massive pulmonary hemorrhage to three standard methods of lung isolation. Hypothesis: The novel method will be as fast or faster than traditional methods. Justification: Lung isolation in massive pulmonary hemorrhage is associated with mortality rates as high as 40%. Current methods of lung isolation are challenging and have a number of limitations. The development of this novel device was a response to the limitations of current solutions and could significantly increase the speed and ease of placing a bronchial blocker under these circumstances. Objectives: (1) To determine the length of time required for successful lung isolation in each of the four methods trialed. (2) To determine the length of time required for intubation in each of the four methods trialed. (3) To describe challenges in each method within the scenario of massive pulmonary hemorrhage. (4) To assess the utility of the model of massive pulmonary hemorrhage in future simulations. Research Design: We propose a within-subject randomized procedure evaluation study comparing the placement of a novel bronchial blocker with three standard methods of lung isolation in a massive pulmonary hemorrhage simulation. Analysis: Mixed effects model will be used to test the difference in total time to lung isolation between the novel method and the other three methods, with the subject as the random variable. If normality and homogeneity assumptions of the mixed-effects model are not fulfilled, then the non-parametric Wilcoxon signed-rank test would be used to compare the novel method to each of the other methods. Time constraints are placed on completion of a task, as such, we will complete sensitivity analysis where we include all participants in the analysis compared to excluding those that were unable to complete at least 1 method.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulmonary Hemorrhage
Keywords
simulation, anesthesia

7. Study Design

Primary Purpose
Device Feasibility
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Recruited anesthesiologists will sequentially perform all four methods of pulmonary blockade on an intubating manikin. The method order will be randomized to control for a learning effect.
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Study trial
Arm Type
Other
Arm Description
All participants will perform pulmonary blockade on an intubating manikin using 4 different methods: Endobronchial intubation with an endotracheal tube; Bronchial blocker attached to the outside of an endotracheal tube; Double lumen endotracheal tube; and Intraluminal placement of bronchial blocker.
Intervention Type
Device
Intervention Name(s)
Bronchial Blocker
Other Intervention Name(s)
Arndt Endobronchial Blocker, Double lumen tube, Endotracheal tube
Intervention Description
Trial of four methods of pulmonary blockade; one novel method and three published methods.
Primary Outcome Measure Information:
Title
Total time to successful lung isolation.
Description
Total time from start of direct laryngoscopy to establishment of lung isolation confirmed by one lung ventilation.
Time Frame
Within 10 minutes from start of direct laryngoscopy
Secondary Outcome Measure Information:
Title
Time to successful intubation
Description
Time from the start of direct laryngoscopy to successful intubation confirmed by ventilation of both lungs.
Time Frame
Within 10 minutes from start of direct laryngoscopy
Title
Time to successful method placement
Description
Time from successful intubation to establishment of lung isolation.
Time Frame
Within 10 minutes from successful intubation
Title
Model utility
Description
Responses on post-study questionnaire for future utility of the model in simulations, based on the Lung Isolation Techniques Simulation Training Evaluation Questionnaire (LITSTEQ) developed by Failor and colleagues (2014) https://doi.org/10.1053/j.jvca.2013.07.015, modified to specify training for massive pulmonary hemorrhage. Graded on a Likert scale of 1-5; 1 - Strongly disagree, 2 - Disagree, 3 - Neutral, 4 - Agree, 5 - Strongly Agree. Higher scores relate to a more positive outcome in assessing the utility of using the simulation model for massive pulmonary hemorrhage training.
Time Frame
At the end of the trial, within an hour of starting the first practice intubation.

10. Eligibility

Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Practicing anesthesiologists Anesthesia fellows Exclusion Criteria: Those who don't want to participate
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Andrew Poznikoff, BSc
Phone
604-875-2000
Ext
1989
Email
apoznikoff@bcchr.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
F Robert Purdy, FRCA
Organizational Affiliation
The University of British Columbia
Official's Role
Principal Investigator
Facility Information:
Facility Name
BC Children's Hospital - Department of Anesthesia
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V5Z 4V4
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Andrew Poznikoff, BSc
Phone
604-875-2000
Ext
1989
Email
apoznikoff@bcchr.ca
First Name & Middle Initial & Last Name & Degree
Andrew Poznikoff, BSc
First Name & Middle Initial & Last Name & Degree
F Robert Purdy, FRCA
First Name & Middle Initial & Last Name & Degree
Michael Barker, FRCA
First Name & Middle Initial & Last Name & Degree
Andrew Morrison, FRCA
First Name & Middle Initial & Last Name & Degree
Matthias Gorges, PhD
First Name & Middle Initial & Last Name & Degree
Alex Zheng, MSc
First Name & Middle Initial & Last Name & Degree
Emma Nielsen, MSc

12. IPD Sharing Statement

Plan to Share IPD
No

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A Novel Method of Lung Isolation Compared With Standard Methods in a Model of Massive Pulmonary Hemorrhage

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