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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DEVICE_FEASIBILITY
Masking
NONE
Enrollment
20
Trial of four methods of pulmonary blockade; one novel method and three published methods.
BC Children's Hospital - Department of Anesthesia
Vancouver, British Columbia, Canada
RECRUITINGTotal time to successful lung isolation.
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
Time to successful intubation
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
Time to successful method placement
Time from successful intubation to establishment of lung isolation.
Time frame: Within 10 minutes from successful intubation
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.
Time frame: At the end of the trial, within an hour of starting the first practice intubation.
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