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

NCT ID: NCT00673517

Last Updated: 2008-11-17

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

COMPLETED

Total Enrollment

20 participants

Study Classification

OBSERVATIONAL

Study Start Date

2007-11-30

Study Completion Date

2008-11-30

Brief Summary

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Although mechanical ventilation is life saving, it is associated with a number of severe complications collectively referred to as ventilator induced lung injury (VILI). VILI contributes to the high morbidity and mortality associated with the acute respiratory distress syndrome (ARDS). Within the context of a randomized study evaluating the feasibility of conducting a study comparing high frequency oscillation to conventional lung protective ventilation in early severe ARDS, we are evaluating the effect of both ventilator strategies on biological markers of VILI.

Detailed Description

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Specific objectives:

To measure known biomarkers conventionally associated with VILI and biotrauma To measure potential novel biomarkers of VILI and biotrauma To identify the best time point for biomarker measurement To collect and store samples for differential expression and genomic analysis

Conditions

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Acute Respiratory Distress Syndrome

Keywords

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Acute respiratory distress syndrome Ventilator induced lung injury High frequency oscillation Lung protective ventilation Biomarkers Biotrauma

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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1

Patients randomized to high frequency oscillation

No interventions assigned to this group

2

Patients randomized to conventional lung protective ventilation

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

Informed consent previously obtained for enrollment in the OSCILLATE study:

1. Acute onset of respiratory failure
2. Endotracheal intubation or tracheostomy
3. Hypoxemia (P:F \<200 mmHg)
4. Bilateral alveolar consolidation

Exclusion Criteria

1\. Refusal of consent to participate in this biomarkers substudy
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Canadian Intensive Care Foundation

OTHER

Sponsor Role collaborator

Unity Health Toronto

OTHER

Sponsor Role lead

Responsible Party

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St. Michael's Hospital

Principal Investigators

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Claudia C DosSantos, MD

Role: PRINCIPAL_INVESTIGATOR

Unity Health Toronto

Locations

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St. Michael's Hospital

Toronto, Ontario, Canada

Site Status

Countries

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Canada

Other Identifiers

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OSCILLATE Biomarkers Substudy

Identifier Type: -

Identifier Source: org_study_id