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

NCT05001607 | Unknown

• 1 other identifier: H20-00662
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Pulmonary Hemorrhage

Keywords

simulation; anesthesia

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Time to successful intubation

  Within 10 minutes from start of direct laryngoscopy

• Time to successful method placement

  Within 10 minutes from successful intubation

• Model utility

  At the end of the trial, within an hour of starting the first practice intubation.

Study Arms (1)

Study trial

OTHER

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

Interventions

Bronchial Blocker DEVICE

Trial of four methods of pulmonary blockade; one novel method and three published methods.

Also known as: Arndt Endobronchial Blocker, Double lumen tube, Endotracheal tube

Study trial

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Practicing anesthesiologists
• Anesthesia fellows

You may not qualify if:

• Those who don't want to participate

Sponsors & Collaborators

• University of British Columbia: lead

Study Sites (1)

BC Children's Hospital - Department of Anesthesia

Vancouver, British Columbia, V5Z 4V4, Canada

RECRUITING

Study Officials

• F Robert Purdy, FRCA

  The University of British Columbia

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Andrew Poznikoff, BSc

CONTACT

604-875-2000; apoznikoff@bcchr.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator

Model Details: 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.

Study Record Dates

• First Submitted: July 30, 2021
• First Posted: August 12, 2021
• Study Start: September 16, 2021
• Primary Completion: July 1, 2022
• Study Completion: October 1, 2022
• Last Updated: September 20, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)