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Completed

NCT Number: NCT00673517

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

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.

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Key information

Conditions

Acute Respiratory Distress Syndrome Lung Diseases Lung Injury Respiration Disorders Respiratory Distress Syndrome Respiratory Tract Diseases Ventilator-Induced Lung Injury

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

St. Michael's Hospital

Toronto, Ontario, M5B1W8, Canada

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

  • Refusal of consent to participate in this biomarkers substudy

Treatment and study plan

Primary outcomes

  1. 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 outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Unity Health Toronto

Other

Collaborators

  • Canadian Intensive Care Foundation

Registry information

Official study 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

Important dates

Study start
2007
Primary completion
2008
Study completion
2008
First posted
May 7, 2008
Registry last updated
Nov 17, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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