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Parent study (OSCILLATE) stopped by the Data Monitoring Committee
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| Name | Class |
|---|---|
| Canadian Intensive Care Foundation | OTHER |
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Mechanical ventilation, although life-saving, damages the lungs through what is known as ventilator-induced lung injury. High frequency oscillation ventilation has been proposed as a ventilation method that may be less injurious to the lungs than conventional mechanical ventilation and may lead to better patient outcomes. To evaluate this hypothesis, the OSCILLATE trial is comparing outcomes in patients with the acute respiratory distress syndrome randomized to high frequency oscillation ventilation vs conventional lung protective ventilation. The present study is a substudy of the OSCILLATE trial looking at biomarkers of ventilator-induced lung injury in blood samples drawn from patients enrolled in OSCILLATE. The objective is to look for biochemical evidence of decreased ventilator-induced lung injury in patients treated with high frequency oscillation ventilation relative to conventional ventilation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Conventional lung protective ventilation | Critically-ill patients with the acute respiratory distress syndrome randomized to the conventional lung protective ventilation arm of the OSCILLATE trial. | ||
| High frequency oscillation ventilation | Critically-ill patients with the acute respiratory distress syndrome randomized to the high frequency oscillation ventilation arm of the OSCILLATE trial. |
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| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in biomarkers of ventilator-induced lung injury | The following biomarkers will be measured in patients enrolled in both arms of the OSCILLATE trial (high frequency oscillation ventilation and conventional lung protective ventilation) at randomization and again at 24 hrs post randomization: IL-1β, IL-6, IL-8, IL-10, IFN-γ, TGF-β, TNF-α, VEGF, sICAM-1, surfactant protein D (SP-D), Krebs von den Lungen protein (KL-6), Clara cell 16 kD protein (CC16), Angiopoietin-1, Angiopoietin-2, and vWF. | 24 hrs |
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Inclusion Criteria:
Exclusion Criteria:
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Critically-ill patients with the acute respiratory distress syndrome enrolled in the OSCILLATE trial (NCT01506401).
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| Name | Affiliation | Role |
|---|---|---|
| Alexandra Binnie, MD, DPhil | University of Toronto | Principal Investigator |
| Claudia dos Santos, MD, PhD | University of Toronto | Principal Investigator |
| Niall Ferguson, MD, MSc | University of Toronto | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| St Michael's Hospital | Toronto | Ontario | M5B 1W8 | Canada | ||
| University Health Network |
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| Label | URL |
|---|---|
| OSCILLATE trial | View source |
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| ID | Term |
|---|---|
| D012128 | Respiratory Distress Syndrome |
| D055397 | Ventilator-Induced Lung Injury |
| ID | Term |
|---|---|
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D012120 | Respiration Disorders |
| D055370 | Lung Injury |
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Blood samples will be drawn to measure the following biomarkers of ventilator-induced lung injury: IL-1β, IL-6, IL-8, IL-10, IFN-γ, TGF-β, TNF-α, VEGF, sICAM-1, surfactant protein D (SP-D), Krebs von den Lungen protein (KL-6), Clara cell 16 kD protein (CC16), Angiopoietin-1, Angiopoietin-2, and vWF.
| Toronto |
| Ontario |
| M5G 2C4 |
| Canada |