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NCT01581255 Clinical Trial

The Effect of High Frequency Oscillation on Biological Markers of Lung Injury

Acute Respiratory Distress Syndrome Clinical Trial

Official title:
The Effect of High Frequency Oscillation on Biological Markers of Lung Injury

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT01581255
Other study ID # OSCILLATE Biomarkers Study
Secondary ID
Status Terminated
Phase N/A
First received April 17, 2012
Last updated September 10, 2012
Start date February 2012
Est. completion date August 2012

Study information
Verified date September 2012
Source Canadian Critical Care Trials Group
Contact n/a
Is FDA regulated No
Health authority Canada: Ethics Review Committee
Study type Observational

Clinical Trial Summary

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.

Recruitment information / eligibility
Status Terminated
Enrollment 2
Est. completion date August 2012
Est. primary completion date August 2012
Accepts healthy volunteers No
Gender Both
Age group 16 Years to 85 Years
Eligibility Inclusion Criteria:

- enrollment in OSCILLATE (NCT01506401)

Exclusion Criteria:

- inability to provide blood samples

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

  • Acute Lung Injury
  • Acute Respiratory Distress Syndrome
  • Lung Injury
  • Respiratory Distress Syndrome, Adult
  • Respiratory Distress Syndrome, Newborn

Locations
Country Name City State
Canada St Michael's Hospital Toronto Ontario
Canada University Health Network Toronto Ontario

Sponsors (2)
Lead Sponsor Collaborator
Canadian Critical Care Trials Group Canadian Intensive Care Foundation

Country where clinical trial is conducted

Canada, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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-1ß, IL-6, IL-8, IL-10, IFN-?, TGF-ß, TNF-a, 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 No
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