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

NCT ID: NCT01581255

Last Updated: 2012-09-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

2 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-02-29

Study Completion Date

2012-08-31

Brief Summary

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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.

Detailed Description

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Conditions

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Acute Respiratory Distress Syndrome

Keywords

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

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

No interventions assigned to this group

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.

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* enrollment in OSCILLATE (NCT01506401)

Exclusion Criteria

* inability to provide blood samples
Minimum Eligible Age

16 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Canadian Intensive Care Foundation

OTHER

Sponsor Role collaborator

Canadian Critical Care Trials Group

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Alexandra Binnie, MD, DPhil

Role: PRINCIPAL_INVESTIGATOR

University of Toronto

Claudia dos Santos, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Toronto

Niall Ferguson, MD, MSc

Role: PRINCIPAL_INVESTIGATOR

University of Toronto

Locations

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St Michael's Hospital

Toronto, Ontario, Canada

Site Status

University Health Network

Toronto, Ontario, Canada

Site Status

Countries

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Canada

Related Links

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http://clinicaltrials.gov/ct2/show/NCT01506401

OSCILLATE trial

Other Identifiers

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OSCILLATE Biomarkers Study

Identifier Type: -

Identifier Source: org_study_id