Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
24 participants
INTERVENTIONAL
2016-04-30
2017-06-30
Brief Summary
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Detailed Description
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Subjects will be followed up daily during their post-operative course in hospital for clinical outcomes. A 30-day phone follow-up will be conducted for vital status and MI.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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Heliox
Cardioplegia enriched with a 70:30 (Helium:Oxygen) Heliox mixture while the patient is on cardiopulmonary bypass
Heliox
Half of the study population will be randomly assigned to receive cardioplegia enriched with a 70:30 (Helium:Oxygen) via a D100 pediatric oxygenator. The Heliox itself will need to be administered via an oxygen regulator using a low flowmeter.
Standard of care
Cardioplegia enriched with a Nitrogen and Oxygen mixture while the patient is on cardiopulmonary bypass
Standard of care
The other half will be randomized to Nitrogen:Oxygen mixture. This will be done through the standard of care cardioplegia apparatus. There will be no novel interventions administered in this group.
Interventions
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Heliox
Half of the study population will be randomly assigned to receive cardioplegia enriched with a 70:30 (Helium:Oxygen) via a D100 pediatric oxygenator. The Heliox itself will need to be administered via an oxygen regulator using a low flowmeter.
Standard of care
The other half will be randomized to Nitrogen:Oxygen mixture. This will be done through the standard of care cardioplegia apparatus. There will be no novel interventions administered in this group.
Eligibility Criteria
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Inclusion Criteria
* Cardiac surgery with CPB where use of a coronary sinus catheter is indicated
Exclusion Criteria
* Recent myocardial infarction (less than 7 days old)
* Left ventricular ejection fraction less than 30%
* Known pregnancy on date of surgery
18 Years
ALL
No
Sponsors
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Unity Health Toronto
OTHER
Responsible Party
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Principal Investigators
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David Mazer, MD
Role: PRINCIPAL_INVESTIGATOR
Unity Health Toronto
Locations
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St. Michael's Hospital
Toronto, Ontario, Canada
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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15 - 311
Identifier Type: -
Identifier Source: org_study_id
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