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

Overview

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.

Full Title of Study: “The Effect of High Frequency Oscillation on Biological Markers of Ventilator Induced Lung Injury (VILI): Nested Translational Biology Sub-Study of the OSCILLATE Pilot Study”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: November 2008

Detailed Description

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

Arms, Groups and Cohorts

  • 1
    • Patients randomized to high frequency oscillation
  • 2
    • Patients randomized to conventional lung protective ventilation

Clinical Trial Outcome Measures

Primary Measures

  • Serum concentration of known biomarkers associated with VILI and biotrauma
    • Time Frame: Baseline, after standardization, 6-10 hours after randomization, 12-16 hours after randomization, 24-30 hours after randomization, 72-76 hours after randomization, and every 3 subsequent days until death, discharge, or completion of the study at 28 days

Secondary Measures

  • Serum concentration of tissue and cell specific markers that are potential novel biomarkers associated with VILI and biotrauma
    • Time Frame: Baseline, after standardization, 6-10 hours after randomization, 12-16 hours after randomization, 24-30 hours after randomization, 72-76 hours after randomization, and every 3 subsequent days until death, discharge, or completion of the study at 28 days

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Unity Health Toronto
  • Collaborator
    • Canadian Intensive Care Foundation
  • Provider of Information About this Clinical Study
    • Claudia DosSantos, MD, FRCPC, St. Michael’s Hospital
  • Overall Official(s)
    • Claudia C DosSantos, MD, Principal Investigator, Unity Health Toronto

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.