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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00673517

Enrollment

Registered

2008-05-07

Start date

2007-11-30

Completion date

2008-11-30

Last updated

2008-11-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Respiratory Distress Syndrome

Keywords

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

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

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Serum concentration of known biomarkers associated with VILI and biotrauma	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

Measure	Time frame
Serum concentration of tissue and cell specific markers that are potential novel biomarkers associated with VILI and biotrauma	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

Countries

Canada

Outcome results