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

September 10, 2012 updated by: Canadian Critical Care Trials Group
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.

Study Overview

Status

Terminated

Conditions

Study Type

Observational

Enrollment (Actual)

2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M5B 1W8
        • St Michael's Hospital
      • Toronto, Ontario, Canada, M5G 2C4
        • University Health Network

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 85 years (ADULT, OLDER_ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Critically-ill patients with the acute respiratory distress syndrome enrolled in the OSCILLATE trial (NCT01506401).

Description

Inclusion Criteria:

  • enrollment in OSCILLATE (NCT01506401)

Exclusion Criteria:

  • inability to provide blood samples

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
24 hrs

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Canadian Critical Care Trials Group

Collaborators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2012

Primary Completion (ACTUAL)

August 1, 2012

Study Completion (ACTUAL)

August 1, 2012

Study Registration Dates

First Submitted

April 17, 2012

First Submitted That Met QC Criteria

April 18, 2012

First Posted (ESTIMATE)

April 20, 2012

Study Record Updates

Last Update Posted (ESTIMATE)

September 12, 2012

Last Update Submitted That Met QC Criteria

September 10, 2012

Last Verified

September 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OSCILLATE Biomarkers Study

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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