SI-EVLP Study: STRESS INDEX in Lung Reconditioning

NCT01729637 | Completed

• 1 other identifier: SI-EVLP
• Study Type: observational
• Target: 11
• Locations: 1 country
• Sites: 1

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.

Conditions

Lung Transplantation

Keywords

Lung Transplantation; Respiratory Mechanics; Isolated lung perfusion; Ex-vivo lung perfusion; Lung mechanics

Outcome Measures

Primary Outcomes (1)

• Presence of mechanical stress as assessed by analysis of the "Stress Index"

  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.

  During EVLP procedure (4 hours)

Secondary Outcomes (1)

• Association between values of Stress Index and occurrence of physiological criteria for EVLP success

  During EVLP procedure (4 hours)

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

consecutive patient sampling from University Ward of Cardio Surgery of St. Giovanni Battista Hospital of Turin

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University of Turin, Italy: lead

Study Sites (1)

University of Turin - Department of Anesthesia and Intensive Care Medicine

Turin, Italy, 10126, Italy

Location

Related Publications (1)

• 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.

  PMID: 26425874 DERIVED

Study Officials

• Pier Paolo Terragni, MD

  University of Turin - Department of Anesthesia and Intensive Care Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD Professor

Study Record Dates

• First Submitted: November 8, 2012
• First Posted: November 20, 2012
• Study Start: July 1, 2011
• Primary Completion: February 1, 2013
• Study Completion: June 1, 2013
• Last Updated: July 8, 2013

Record last verified: 2013-07

Locations

IT (1)