A Novel Method of Lung Isolation Compared With Standard Methods in a Model of Massive Pulmonary Hemorrhage
NCT ID: NCT05001607
Last Updated: 2021-09-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
20 participants
INTERVENTIONAL
2021-09-16
2022-10-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NA
SINGLE_GROUP
DEVICE_FEASIBILITY
NONE
Study Groups
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Study trial
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.
Bronchial Blocker
Trial of four methods of pulmonary blockade; one novel method and three published methods.
Interventions
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Bronchial Blocker
Trial of four methods of pulmonary blockade; one novel method and three published methods.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Anesthesia fellows
Exclusion Criteria
ALL
Yes
Sponsors
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University of British Columbia
OTHER
Responsible Party
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F. Robert Purdy
Principle Investigator
Principal Investigators
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F Robert Purdy, FRCA
Role: PRINCIPAL_INVESTIGATOR
The University of British Columbia
Locations
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BC Children's Hospital - Department of Anesthesia
Vancouver, British Columbia, Canada
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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H20-00662
Identifier Type: -
Identifier Source: org_study_id
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