Protective Ventilatory Strategy in Potential Organ Donors

Mechanical Ventilation Clinical Trial

Official title: a Randomised Control Trial on Protective Ventilatory Strategy in Potential Organ Donors

Status Unknown status

Clinical Trial Summary

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.

Clinical Trial Description

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. ;

Related Conditions & MeSH terms

• Mechanical Ventilation

• NCT number: NCT00260676
• Study type: Interventional
• Source: University of Turin, Italy
• Contact: luciana mascia, MD PhD
• Phone: 390116335600
• Email: luciana.mascia@unito.it
• Status: Unknown status
• Phase: Phase 3
• Start date: September 2004
• Completion date: January 2010