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The HELICOPTER-1 Trial is a single centre pilot study to determine the feasibility of administering Heliox in cardioplegia during cardiac surgery and whether it has the potential to reduce the incidence and severity of myocardial ischemia during and after cardiac surgery.
The HELICOPTER-1 Trial is a single centre, randomized trial evaluating the feasibility of administration of Heliox for prevention of myocardial ischemia in patients undergoing cardiac surgery. Half of the study population will be randomly assigned to the receive cardioplegia enriched with a 70:30 (Helium:Oxygen) Heliox mixture, while the other half will be randomized to receive the current clinical standard of care (nitrogen and oxygen in cardioplegia).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Heliox | Experimental | Cardioplegia enriched with a 70:30 (Helium:Oxygen) Heliox mixture while the patient is on cardiopulmonary bypass |
|
| Standard of care | Active Comparator | Cardioplegia enriched with a Nitrogen and Oxygen mixture while the patient is on cardiopulmonary bypass |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Heliox | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Feasibility of using Heliox to oxygenate the blood cardioplegia | To determine the feasibility of using Heliox to oxygenate the blood cardioplegia. Feasibility will be measured according to subject enrollment rates and to measurement of the blood gas content of the cardioplegia solutions. | 30 days from the intervention |
| Measure | Description | Time Frame |
|---|---|---|
| New Myocardial Infarction | Myocardial infarction (MI) will be defined according to the Third Universal Definition of MI using the following two criteria:
|
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| David Mazer, MD | Contact | 416-864-5825 | mazerd@smh.ca | |
| Constantine Dalamagas, RRT, CPC | Contact | 416-864-6060 | 5753 | DalamagasC@smh.ca |
| Name | Affiliation | Role |
|---|---|---|
| David Mazer, MD | Unity Health Toronto | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| St. Michael's Hospital | Recruiting | Toronto | Ontario | M5B1W8 | Canada |
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| ID | Term |
|---|---|
| C038949 | heliox |
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
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| Standard of care | Other | 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. |
|
| 30 days from the intervention |