- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00673517
The Effect of High Frequency Oscillation on Biological Markers of Lung Injury
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 Overview
Status
Conditions
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
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Locations
-
-
Ontario
-
Toronto, Ontario, Canada, M5B1W8
- St. Michael's Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
Informed consent previously obtained for enrollment in the OSCILLATE study:
- Acute onset of respiratory failure
- Endotracheal intubation or tracheostomy
- Hypoxemia (P:F <200 mmHg)
- Bilateral alveolar consolidation
Exclusion Criteria:
1. Refusal of consent to participate in this biomarkers substudy
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
---|
1
Patients randomized to high frequency oscillation
|
2
Patients randomized to conventional lung protective ventilation
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
|
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 Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
|
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
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Claudia C DosSantos, MD, Unity Health Toronto
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- OSCILLATE Biomarkers Substudy
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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