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

Pulmonary Hemorrhage Clinical Trial

— BloodyBlocker  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05001607
• Other study ID #: H20-00662
• Status: Recruiting
• Phase: N/A
• Start date: September 16, 2021
• Est. completion date: October 2022

Study information

• Verified date: September 2021
• Source: University of British Columbia
• Contact: Andrew Poznikoff, BSc
• Phone: 604-875-2000
• Email: apoznikoff[@]bcchr.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: October 2022
• Est. primary completion date: July 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Practicing anesthesiologists

• Anesthesia fellows

Exclusion Criteria:

• Those who don't want to participate

Related Conditions & MeSH terms

• Hemorrhage
• Pulmonary Hemorrhage

Intervention

Device:
• Bronchial Blocker
Trial of four methods of pulmonary blockade; one novel method and three published methods.

Locations

Country	Name	City	State
Canada	BC Children's Hospital - Department of Anesthesia	Vancouver	British Columbia

Sponsors (1)

Lead Sponsor	Collaborator
University of British Columbia

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total time to successful lung isolation.	Total time from start of direct laryngoscopy to establishment of lung isolation confirmed by one lung ventilation.	Within 10 minutes from start of direct laryngoscopy
Secondary	Time to successful intubation	Time from the start of direct laryngoscopy to successful intubation confirmed by ventilation of both lungs.	Within 10 minutes from start of direct laryngoscopy
Secondary	Time to successful method placement	Time from successful intubation to establishment of lung isolation.	Within 10 minutes from successful intubation
Secondary	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.	At the end of the trial, within an hour of starting the first practice intubation.