Clinical trial NCT05001607: A Novel Method of Lung Isolation Compared With Standard Methods in a Model of Massive Pulmonary Hemorrhage
Official title: A Novel Method of Lung Isolation Compared With Standard Methods in a Model of Massive Pulmonary Hemorrhage.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pulmonary Hemorrhage
Keywords: simulation
anesthesia
Lead sponsor: University of British Columbia
Sponsor class: OTHER
First posted: 2021-08-12
Enrollment: 20
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention 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.
Primary purpose: DEVICE_FEASIBILITY

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.

Eligibility criteria: Inclusion Criteria:

* Practicing anesthesiologists
* Anesthesia fellows

Exclusion Criteria:

* Those who don't want to participate

Primary outcomes:
measure: Total time to successful lung isolation.
timeFrame: Within 10 minutes from start of direct laryngoscopy
Secondary outcomes:
measure: Time to successful intubation
timeFrame: Within 10 minutes from start of direct laryngoscopy
measure: Time to successful method placement
timeFrame: Within 10 minutes from successful intubation
measure: Model utility
timeFrame: At the end of the trial, within an hour of starting the first practice intubation.
Other outcomes:
Locations:
city: Vancouver
country: Canada
facility: BC Children's Hospital - Department of Anesthesia
state: British Columbia
Study officials:
affiliation: The University of British Columbia
name: F Robert Purdy, FRCA
role: PRINCIPAL_INVESTIGATOR
References: