Clinical trial NCT01729637: SI-EVLP Study: STRESS INDEX in Lung Reconditioning
Official title: Normothermic Ex-vivo Lung Perfusion: Clinical Experience of the Pressure/Time Curve Profile Study (Stress Index)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Lung Transplantation
Keywords: Lung Transplantation
Respiratory Mechanics
Isolated lung perfusion
Ex-vivo lung perfusion
Lung mechanics
Lead sponsor: University of Turin, Italy
Sponsor class: OTHER
First posted: 2012-11-20
Enrollment: 11
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: consecutive patient sampling from University Ward of Cardio Surgery of St. Giovanni Battista Hospital of Turin

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Presence of mechanical stress as assessed by analysis of the "Stress Index"
timeFrame: During EVLP procedure (4 hours)
Secondary outcomes:
measure: Association between values of Stress Index and occurrence of physiological criteria for EVLP success
timeFrame: During EVLP procedure (4 hours)
Other outcomes:
Locations:
city: Turin
country: Italy
facility: University of Turin - Department of Anesthesia and Intensive Care Medicine
Study officials:
affiliation: University of Turin - Department of Anesthesia and Intensive Care Medicine
name: Pier Paolo Terragni, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Terragni PP, Fanelli V, Boffini M, Filippini C, Cappello P, Ricci D, Del Sorbo L, Faggiano C, Brazzi L, Frati G, Venuta F, Mascia L, Rinaldi M, Ranieri VM. Ventilatory Management During Normothermic Ex Vivo Lung Perfusion: Effects on Clinical Outcomes. Transplantation. 2016 May;100(5):1128-35. doi: 10.1097/TP.0000000000000929.