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Trial record 11 of 20 for:    evlp

SI-EVLP Study: STRESS INDEX in Lung Reconditioning

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01729637
Recruitment Status : Completed
First Posted : November 20, 2012
Last Update Posted : July 8, 2013
Information provided by (Responsible Party):
Marco Ranieri, University of Turin, Italy

Brief Summary:
In order to minimize mechanical stress the investigators propose to implement EVLP procedure with a ventilation monitoring guided by the analysis of the Paw-t shape.

Condition or disease
Lung Transplantation

Detailed Description:

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.

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Study Type : Observational
Actual Enrollment : 11 participants
Time Perspective: Prospective
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

Primary Outcome Measures :
  1. 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.

Secondary Outcome Measures :
  1. Association between values of Stress Index and occurrence of physiological criteria for EVLP success [ Time Frame: During EVLP procedure (4 hours) ]

Information from the National Library of Medicine

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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
consecutive patient sampling from University Ward of Cardio Surgery of St. Giovanni Battista Hospital of Turin

Inclusion Criteria:

  • High risk donor lung, define as:
  • the ratio of partial pressure arterial oxygen and fraction of inspired oxygen less than 300
  • pulmonary edema
  • poor lung deflation or inflation
  • blood transfusions exceeding 10 units
  • donation after cardiac death as defined by Maastricht category III o IV

Exclusion Criteria:

  • donors lung with established pneumonia
  • donors lung with severe mechanical lung injury
  • donors lung with gross gastric aspiration

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01729637

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University of Turin - Department of Anesthesia and Intensive Care Medicine
Turin, Italy, 10126
Sponsors and Collaborators
University of Turin, Italy
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Principal Investigator: Pier Paolo Terragni, MD University of Turin - Department of Anesthesia and Intensive Care Medicine

Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Marco Ranieri, MD Professor, University of Turin, Italy Identifier: NCT01729637     History of Changes
Other Study ID Numbers: SI-EVLP
First Posted: November 20, 2012    Key Record Dates
Last Update Posted: July 8, 2013
Last Verified: July 2013
Keywords provided by Marco Ranieri, University of Turin, Italy:
Lung Transplantation
Respiratory Mechanics
Isolated lung perfusion
Ex-vivo lung perfusion
Lung mechanics