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| Name | Class |
|---|---|
| Ministry of Health, Italy | OTHER_GOV |
The aim of the study is to verify if a "PROTECTIVE" ventilatory strategy (low tidal volume and high PEEP, application of CPAP during the apnea test and recruitment maneuvers), improves lung function and increases the number of lungs eligible for transplantation.
Lung transplantation reduces mortality in patients with severe pulmonary diseases. While 50-70% of kidney, liver and heart are eligible for transplantation, only 20% of the lungs fit the criteria for transplant. More than 30% of the lungs theoretically suitable for donation are not actually collected because following brain death they develop severe hypoxemia and abnormal chest X-ray. Guidelines for critical care management of potential organ donors suggest that after the diagnosis of brain death, treatment priority can be shifted from cerebral protection to a strategy aimed at preserving solid organ perfusion and function. However the ventilatory strategy recommended for potential lung donors is similar to the one proposed for brain injured patients. This ventilatory strategy based on high Vt and low PEEP may induce a further exacerbation of the pulmonary and systemic inflammatory response in patients with acute lung injury/acute respiratory distress syndrome. Moreover, recent data suggest that this strategy may be harmful in "normal lungs" of mechanical ventilated patients. Aim of the study is to verify if a "PROTECTIVE" ventilatory strategy (low tidal volume and high PEEP, application of CPAP during the apnea test and recruitment maneuvers) improves lung function. Primary end point of the study is to increase the number of lungs that meet the eligibility criteria for transplantation. Secondary end point is to increase the number of lungs really transplanted.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| conventional ventilation, protective ventilation | Other |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| change ventilation | Procedure | reduction of tidal volume, increase of PEEP, recruiting maneuver, apnea test during CPAP |
|
| Measure | Description | Time Frame |
|---|---|---|
| To increase the number of lungs that meet the eligibility criteria for transplantation | end of brain death diagnosis observation period |
| Measure | Description | Time Frame |
|---|---|---|
| To increase the number of lungs really transplanted | end of brain death diagnosis observation period | |
| Interim analysis at 100 subjects enrolled will be considered | six months after transplant |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| luciana mascia, MD PhD | Contact | 390116335600 | luciana.mascia@unito.it | |
| daniela pasero, MD | Contact | 390116334002 | dpasero@molinette.piemonte.it |
| Name | Affiliation | Role |
|---|---|---|
| luciana mascia, MD PhD | University of Turin, Italy | Principal Investigator |
| marco ranieri, MD | University of Turin, Italy | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Turin, Department of Anesthesia and Intensive Care Medicine | Recruiting | Turin | 10126 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21156950 | Derived | Mascia L, Pasero D, Slutsky AS, Arguis MJ, Berardino M, Grasso S, Munari M, Boifava S, Cornara G, Della Corte F, Vivaldi N, Malacarne P, Del Gaudio P, Livigni S, Zavala E, Filippini C, Martin EL, Donadio PP, Mastromauro I, Ranieri VM. Effect of a lung protective strategy for organ donors on eligibility and availability of lungs for transplantation: a randomized controlled trial. JAMA. 2010 Dec 15;304(23):2620-7. doi: 10.1001/jama.2010.1796. |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Oct 10, 2012 | |
| Reset | Nov 8, 2012 | |
| Release | May 30, 2014 | |
| Reset | Jul 1, 2014 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Oct 10, 2012 | Nov 8, 2012 | |||
| May 30, 2014 |
| ID | Term |
|---|---|
| D001926 | Brain Death |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D003128 | Coma |
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| Jul 1, 2014 |
| D014474 |
| Unconsciousness |
| D003244 | Consciousness Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D003643 | Death |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |