Lung TransplantationNCT01729637
SI-EVLP Study: STRESS INDEX in Lung Reconditioning
An observational study of Lung Transplantation, run by University of Turin, Italy at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Lung Transplantation
- How many people
- 11 participants
- Where
- 1 siteItaly
- Study dates
- Jul 2011to Jun 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Study population: consecutive patient sampling from University Ward of Cardio Surgery of St. Giovanni Battista Hospital of Turin
Who may be able to join
- 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
Who cannot join
- donors lung with established pneumonia
- donors lung with severe mechanical lung injury
- donors lung with gross gastric aspiration
Trial locations and contacts
1 site in 1 country.
Italy1 site
University of Turin - Department of Anesthesia and Intensive Care Medicine
Turin, Italy, 10126
About this study
Official title: Normothermic Ex-vivo Lung Perfusion: Clinical Experience of the Pressure/Time Curve Profile Study (Stress Index)
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.
Read the 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
- Lung Transplantation
- Keywords
- Lung Transplantation, Respiratory Mechanics, Isolated lung perfusion, Ex-vivo lung perfusion, Lung mechanics
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: During EVLP procedure (4 hours)
Secondary outcomes (1)
Association between values of Stress Index and occurrence of physiological criteria for EVLP success
Measured: During EVLP procedure (4 hours)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2012 (estimated)
- Study startJul 2011
- Primary completionFeb 2013
- Study completionJun 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Lung TransplantationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Prospective
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Turin, Italy
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marco Ranieri, University of Turin, Italy
- Investigators
- Pier Paolo Terragni, MD, Principal investigator, University of Turin - Department of Anesthesia and Intensive Care Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01729637
- Sponsor's protocol ID
- SI-EVLP
- Status last verified
- Jul 2013
- First submitted
- 8 Nov 2012
- Last updated
- 8 Jul 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 26425874
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Normothermic Ex-vivo Lung Perfusion: Clinical Experience of the Pressure/Time Curve Profile Study (Stress Index)
- ClinicalTrials.gov ID
- NCT01729637
- Acronym / sponsor ID
- SI-EVLP
- Conditions
- Lung Transplantation
- Keywords
- Lung Transplantation, Respiratory Mechanics, Isolated lung perfusion, Ex-vivo lung perfusion, Lung mechanics
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- University of Turin, ItalyUniversity, hospital or other
- Study start
- Jul 2011
- Primary completion
- Feb 2013 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 20 Nov 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Time perspective
- Prospective
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- consecutive patient sampling from University Ward of Cardio Surgery of St. Giovanni Battista Hospital of Turin
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (3 listed)
- donors lung with established pneumonia
- donors lung with severe mechanical lung injury
- donors lung with gross gastric aspiration
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
1 secondary outcome
Association between values of Stress Index and occurrence of physiological criteria for EVLP success
Time frame: During EVLP procedure (4 hours)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2013.
- Derived from this study: PubMed 26425874Terragni 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pier Paolo Terragni, MD principal investigator
University of Turin - Department of Anesthesia and Intensive Care Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lung Transplantation, run by University of Turin, Italy at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Jul 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Presence of mechanical stress as assessed by analysis of the "Stress Index" (time frame: During EVLP procedure (4 hours)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01729637, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jul 2013.