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

Status

Terminated

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01581255

Enrollment

Registered

2012-04-20

Start date

2012-02-29

Completion date

2012-08-31

Last updated

2012-09-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Respiratory Distress Syndrome

Keywords

acute respiratory distress syndrome, high frequency oscillation ventilation, ventilator-induced lung injury, biomarkers

Brief 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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

16 Years to 85 Years

Healthy volunteers

Inclusion criteria

* enrollment in OSCILLATE (NCT01506401)

Exclusion criteria

* inability to provide blood samples

Design outcomes

Primary

Measure	Time frame	Description
Change from baseline in biomarkers of ventilator-induced lung injury	24 hrs	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.

Countries

Canada

Outcome results