Pulmonary HemorrhageBloodyBlockerNCT05001607
A Novel Method of Lung Isolation Compared With Standard Methods in a Model of Massive Pulmonary Hemorrhage
A study testing Bronchial Blocker in people with Pulmonary Hemorrhage, run by University of British Columbia at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Pulmonary Hemorrhage
- What is being tested?
- Bronchial Blocker
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteCanada
- Study dates
- 16 Sep 2021to Oct 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Practicing anesthesiologists
- Anesthesia fellows
Who cannot join
- Those who don't want to participate
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
BC Children's Hospital - Department of Anesthesia
Vancouver, British Columbia, V5Z 4V4
Andrew Poznikoff, BSc, 604-875-2000 ext. 1989, apoznikoff@bcchr.ca
Andrew Poznikoff, BSc
About this study
Official title: 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.
Read the 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.
- Conditions
- Pulmonary Hemorrhage
- Being tested
- Bronchial Blocker
- Keywords
- simulation, anesthesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bronchial BlockerDevice
Also called Arndt Endobronchial Blocker, Double lumen tube, Endotracheal tube
Trial of four methods of pulmonary blockade; one novel method and three published methods.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Bronchial Blocker |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total time to successful lung isolation.
Total time from start of direct laryngoscopy to establishment of lung isolation confirmed by one lung ventilation.
Measured: Within 10 minutes from start of direct laryngoscopy
Secondary outcomes (3)
Time to successful intubation
Time from the start of direct laryngoscopy to successful intubation confirmed by ventilation of both lungs.
Measured: Within 10 minutes from start of direct laryngoscopy
Time to successful method placement
Time from successful intubation to establishment of lung isolation.
Measured: 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.
Measured: At the end of the trial, within an hour of starting the first practice intubation.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2021
- Study start16 Sep 2021
- Primary completionJul 2022 (estimated)
- Study completionOct 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary HemorrhageStudies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- 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.
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, F. Robert Purdy, University of British Columbia
- Investigators
- F Robert Purdy, FRCA, Principal investigator, The University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05001607
- Sponsor's protocol ID
- H20-00662
- Acronym
- BloodyBlocker
- Status last verified
- Sep 2021
- First submitted
- 30 Jul 2021
- Last updated
- 20 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Novel Method of Lung Isolation Compared With Standard Methods in a Model of Massive Pulmonary Hemorrhage.
- ClinicalTrials.gov ID
- NCT05001607
- Acronym / sponsor ID
- BloodyBlocker / H20-00662
- Conditions
- Pulmonary Hemorrhage
- Keywords
- simulation, anesthesia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Study start
- 16 Sep 2021 (actual)
- Primary completion
- Jul 2022 (estimated)
- Study completion
- Oct 2022 (estimated)
- First posted
- 12 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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.
| Arm | Type | Receives |
|---|---|---|
| Study trial | Other | Device: Bronchial BlockerAll 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Practicing anesthesiologists
- Anesthesia fellows
Key exclusion criteria (1 listed)
- Those who don't want to participate
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bronchial BlockerAlso: Arndt Endobronchial Blocker, Double lumen tube, Endotracheal tubeTrial of four methods of pulmonary blockade; one novel method and three published methods. | Device | Study trial |
Primary outcome
Total time to successful lung isolation.
Time frame: Within 10 minutes from start of direct laryngoscopy
Total time from start of direct laryngoscopy to establishment of lung isolation confirmed by one lung ventilation.
3 secondary outcomes
Time to successful intubation
Time frame: Within 10 minutes from start of direct laryngoscopy
Time to successful method placement
Time frame: Within 10 minutes from successful intubation
Model utility
Time frame: At the end of the trial, within an hour of starting the first practice intubation.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Sep 2021.
- Individual participant dataSharing planned: No
Related trials for Pulmonary Hemorrhage
Active, not recruitingPhase 1/2
Efficacy and Safety of Baricitinib in the Post-intracerebral Hemorrhage Pulmonary Injury
Pulmonary Injury After Intracerebral Hemorrhage
RecruitingPhase 3
REGN7508 in Adult Participants for Prevention of Cancer-Associated Thrombosis
Cancer-Associated Thrombosis (CAT)
RecruitingObservational study
Pharmacokinetics, Pharmacodynamics, and Safety Profile of Understudied Drugs Administered to Children Per Standard of Care (POPS)
Coronavirus Infection (COVID-19), Pulmonary Arterial Hypertension
Active, not recruitingPhase 3
Prophylactic Endobronchial Tranexamic Acid to Reduce Bleeding in Transbronchial Cryobiopsy
Hemorrhage Lung, Endobronchial Mass
Active, not recruitingPhase 2
A Clinical Efficacy and Safety Study of OHB-607 in Preventing Bronchopulmonary Dysplasia in Extremely Premature Infants
Bronchopulmonary Dysplasia, Chronic Lung Disease of Prematurity
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
F Robert Purdy, FRCA principal investigator
The University of British Columbia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bronchial Blocker in people with Pulmonary Hemorrhage, run by University of British Columbia at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Andrew Poznikoff, BSc (604-875-2000 ext. 1989, apoznikoff@bcchr.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total time to successful lung isolation. (time frame: Within 10 minutes from start of direct laryngoscopy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Sep 2021; AzTrials last refreshed its copy on 29 Oct 2026.