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

Completed

• Conditions: Acute Respiratory Distress Syndrome

• Registration Number: NCT00673517
• Lead Sponsor: Unity Health Toronto

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

Study Timeline

• Study Start: 2007-11
• Study First Submitted: 2008-05-05
• Study First Submitted QC: 2008-05-05
• Study First Posted: 2008-05-07
• Status Verified: 2008-11
• Primary Completion: 2008-11
• Study Completion: 2008-11
• Last Update Submitted: 2008-11-14
• Last Update Posted: 2008-11-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

St. Michael's Hospital; 🇨🇦 Toronto, Ontario, Canada