SI-EVLP Study: STRESS INDEX in Lung Reconditioning
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|ClinicalTrials.gov Identifier: NCT01729637|
Recruitment Status : Completed
First Posted : November 20, 2012
Last Update Posted : July 8, 2013
|Condition or disease|
Increase of interest about technique of Ex-Vivo Lung Perfusion (EVLP) has highlighted the need of new approaches to respiratory mechanics monitoring to prevent lung stress in atypical physiological settings.
Airway pressure/time curve (Paw-t) shape analysis at constant flow ventilation (Stress Index, SI) is thought to be predictor of lung stress; so the SI coefficient may therefore identify and quantify mechanical stress during ventilation. (1) In experimental studies, the threshold values for SI that best discriminated lungs with signs of Ventilator Induced Lung Injury ranged between 0.9 and 1.1. (2) During EVLP, the isolated lungs are free from the effect of chest wall impairment and represent the effective response of lung parenchyma to ventilatory setting.
Use of SI monitoring in isolated and perfuse lung reconditioning, may be an useful tool to prevent hyperinflation and opening-closing conditions by titrating optimal protective ventilation As previously reported by our group, in the first trial of lung reconditioning, signs of mechanical stress were detected with Paw-t curve. (3) Therefore we implemented EVLP procedure with continuous stress index analysis to detect and quantify the occurrence of hyperinflation or opening closing condition.
|Study Type :||Observational|
|Actual Enrollment :||11 participants|
|Official Title:||Normothermic Ex-vivo Lung Perfusion: Clinical Experience of the Pressure/Time Curve Profile Study (Stress Index)|
|Study Start Date :||July 2011|
|Actual Primary Completion Date :||February 2013|
|Actual Study Completion Date :||June 2013|
- Presence of mechanical stress as assessed by analysis of the "Stress Index" [ Time Frame: During EVLP procedure (4 hours) ]Stress index is the exponential coefficient of the equation describing the shape of the airway opening pressure vs time (Paw-t) curve during constant flow. This approach is based on the observation that, at constant flow the rate of change of the Paw-t curve corresponds to the rate of change of the compliance of the respiratory system during tidal inflation. A progressive increase in slope (i.e. a downward concavity of the curve) indicates that compliance is progressively increasing with tidal inflation (tidal recruitment). A progressive decrease in slope (i.e. a upward convexity of the curve) indicates that compliance is decreasing with tidal inflation (tidal hyperinflation). Clinical and experimental data show that presence of Stress Index values indicating mechanical stress are associated to morphological, histological and inflammatory evidence of ventilator induce lung injury.
- Association between values of Stress Index and occurrence of physiological criteria for EVLP success [ Time Frame: During EVLP procedure (4 hours) ]
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Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01729637
|University of Turin - Department of Anesthesia and Intensive Care Medicine|
|Turin, Italy, 10126|
|Principal Investigator:||Pier Paolo Terragni, MD||University of Turin - Department of Anesthesia and Intensive Care Medicine|