Clinical trial NCT00673517: The Effect of High Frequency Oscillation on Biological Markers of Lung Injury
Official title: 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: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute Respiratory Distress Syndrome
Keywords: Acute respiratory distress syndrome
Ventilator induced lung injury
High frequency oscillation
Lung protective ventilation
Biomarkers
Biotrauma
Lead sponsor: Unity Health Toronto
Sponsor class: OTHER
Collaborators: name: Canadian Intensive Care Foundation
First posted: 2008-05-07
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subset of patients enrolled in the parent study (OSCILLATE- #NCT00474656) Patients enrolled in the parent study have early severe acute respiratory syndrome and will be recruited from a critical care environment

Brief summary: 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: 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

Eligibility criteria: 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

Primary outcomes:
measure: Serum concentration of known biomarkers associated with VILI and biotrauma
timeFrame: 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 outcomes:
measure: Serum concentration of tissue and cell specific markers that are potential novel biomarkers associated with VILI and biotrauma
timeFrame: 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
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: St. Michael's Hospital
state: Ontario
Study officials:
affiliation: Unity Health Toronto
name: Claudia C DosSantos, MD
role: PRINCIPAL_INVESTIGATOR
References: