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

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ClinicalTrials.gov Identifier: NCT01581255
Recruitment Status : Terminated (Parent study (OSCILLATE) stopped by the Data Monitoring Committee)
First Posted : April 20, 2012
Last Update Posted : September 12, 2012
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
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.

Condition or disease
Acute Respiratory Distress Syndrome

Study Design

Study Type : Observational
Actual Enrollment : 2 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Effect of High Frequency Oscillation on Biological Markers of Lung Injury
Study Start Date : February 2012
Primary Completion Date : August 2012
Study Completion Date : August 2012


Groups and Cohorts

Group/Cohort
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.


Outcome Measures

Primary Outcome Measures :
  1. Change from baseline in biomarkers of ventilator-induced lung injury [ Time Frame: 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.


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.

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years to 85 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Critically-ill patients with the acute respiratory distress syndrome enrolled in the OSCILLATE trial (NCT01506401).
Criteria

Inclusion Criteria:

  • enrollment in OSCILLATE (NCT01506401)

Exclusion Criteria:

  • inability to provide blood samples
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01581255


Locations
Canada, Ontario
St Michael's Hospital
Toronto, Ontario, Canada, M5B 1W8
University Health Network
Toronto, Ontario, Canada, M5G 2C4
Sponsors and Collaborators
Canadian Critical Care Trials Group
Canadian Intensive Care Foundation
Investigators
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:
Responsible Party: Canadian Critical Care Trials Group
ClinicalTrials.gov Identifier: NCT01581255     History of Changes
Other Study ID Numbers: OSCILLATE Biomarkers Study
First Posted: April 20, 2012    Key Record Dates
Last Update Posted: September 12, 2012
Last Verified: September 2012

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