Clinical Trials Directory

Trials / Completed

CompletedNCT01729637

SI-EVLP Study: STRESS INDEX in Lung Reconditioning

Normothermic Ex-vivo Lung Perfusion: Clinical Experience of the Pressure/Time Curve Profile Study (Stress Index)

Status
Completed
Phase
Study type
Observational
Enrollment
11 (actual)
Sponsor
University of Turin, Italy · Academic / Other
Sex
All
Age
65 Years
Healthy volunteers
Not accepted

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.

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.

Conditions

Timeline

Start date
2011-07-01
Primary completion
2013-02-01
Completion
2013-06-01
First posted
2012-11-20
Last updated
2013-07-08

Locations

1 site across 1 country: Italy

Source: ClinicalTrials.gov record NCT01729637. Inclusion in this directory is not an endorsement.