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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Pulmonary Hemorrhage
• Intervention / Treatment: Device: Bronchial Blocker

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.

• Study Type: Interventional
• Enrollment (Anticipated): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Andrew Poznikoff, BSc; Phone Number: 1989 604-875-2000; Email: apoznikoff@bcchr.ca

Study Locations

• Canada
  • British Columbia
    • Vancouver, British Columbia, Canada, V5Z 4V4
      • Recruiting
      • BC Children's Hospital - Department of Anesthesia
      • Contact: Andrew Poznikoff, BSc; Phone Number: 1989 604-875-2000; Email: apoznikoff@bcchr.ca
      • Principal Investigator: F Robert Purdy, FRCA
      • Sub-Investigator: Michael Barker, FRCA
      • Sub-Investigator: Andrew Morrison, FRCA
      • Sub-Investigator: Alex Zheng, MSc
      • Sub-Investigator: Emma Nielsen, MSc

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Practicing anesthesiologists
• Anesthesia fellows

Exclusion Criteria:

• Those who don't want to participate

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Device Feasibility
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: 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.	Device: Bronchial Blocker; Trial of four methods of pulmonary blockade; one novel method and three published methods.; Other Names: Arndt Endobronchial Blocker; Double lumen tube; Endotracheal tube

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Time to successful method placement	Time from successful intubation to establishment of lung isolation.	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.	At the end of the trial, within an hour of starting the first practice intubation.

Collaborators and Investigators

• Sponsor: University of British Columbia
• Investigators: Principal Investigator: F Robert Purdy, FRCA, The University of British Columbia

Study record dates

Study Major Dates

• Study Start (Actual): September 16, 2021
• Primary Completion (Anticipated): July 1, 2022
• Study Completion (Anticipated): October 1, 2022

Study Registration Dates

• First Submitted: July 30, 2021
• First Submitted That Met QC Criteria: August 5, 2021
• First Posted (Actual): August 12, 2021

Study Record Updates

• Last Update Posted (Actual): September 20, 2021
• Last Update Submitted That Met QC Criteria: September 16, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Keywords: anesthesia; simulation
• Additional Relevant MeSH Terms: Pathologic Processes; Hemorrhage
• Other Study ID Numbers: H20-00662

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No