The Effect of High Frequency Oscillation on Biological Markers of Lung Injury
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Purpose
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.
| Condition |
|---|
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Acute Respiratory Distress Syndrome |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | The Effect of High Frequency Oscillation on Biological Markers of Lung Injury |
- Change from baseline in biomarkers of ventilator-induced lung injury [ Time Frame: 24 hrs ] [ Designated as safety issue: No ]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.
Biospecimen Retention: Samples Without DNA
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.
| Enrollment: | 2 |
| Study Start Date: | February 2012 |
| Study Completion Date: | August 2012 |
| Primary Completion Date: | August 2012 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
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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.
|
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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.
|
Eligibility| Ages Eligible for Study: | 16 Years to 85 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Critically-ill patients with the acute respiratory distress syndrome enrolled in the OSCILLATE trial (NCT01506401).
Inclusion Criteria:
- enrollment in OSCILLATE (NCT01506401)
Exclusion Criteria:
- inability to provide blood samples
Contacts and Locations| Canada, Ontario | |
| St Michael's Hospital | |
| Toronto, Ontario, Canada, M5B 1W8 | |
| University Health Network | |
| Toronto, Ontario, Canada, M5G 2C4 | |
| Principal Investigator: | 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 |
More Information
Additional Information:
No publications provided
| Responsible Party: | Canadian Critical Care Trials Group |
| ClinicalTrials.gov Identifier: | NCT01581255 History of Changes |
| Other Study ID Numbers: | OSCILLATE Biomarkers Study |
| Study First Received: | April 17, 2012 |
| Last Updated: | September 10, 2012 |
| Health Authority: | Canada: Ethics Review Committee |
Keywords provided by Canadian Critical Care Trials Group:
|
acute respiratory distress syndrome high frequency oscillation ventilation ventilator-induced lung injury biomarkers |
Additional relevant MeSH terms:
|
Respiratory Distress Syndrome, Newborn Respiratory Distress Syndrome, Adult Acute Lung Injury Lung Injury Lung Diseases Respiratory Tract Diseases |
Respiration Disorders Infant, Premature, Diseases Infant, Newborn, Diseases Thoracic Injuries Wounds and Injuries |
ClinicalTrials.gov processed this record on May 16, 2013