a Randomised Control Trial on Protective Ventilatory Strategy in Potential Organ Donors
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Mechanical Ventilation
- Sponsor
- University of Turin, Italy
- Enrollment
- 200
- Locations
- 1
- Primary Endpoint
- To increase the number of lungs that meet the eligibility criteria for transplantation
- Last Updated
- 16 years ago
Overview
Brief 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.
Detailed 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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Age: 18-65 years
- •Chest X-ray: no infiltrates
- •Duration of mechanical ventilation from the admission to ICU to the clinical diagnosis of brain death \< 5 days
- •No history of Smoking (1 pack/day for 20 years; 1/2 pack/day for 40 years; 2 packs/day for 10 years)
- •No history of Asthma
- •No history of COPD
- •No history of Trauma
- •No history of Thoracic surgery
Exclusion Criteria
- •Evidence of aspiration (chest X-ray or bronchoscopy) or sepsis
- •Purulent secretions (tracheal suction or bronchoscopy)
- •Sputum Gram stain with bacteria, fungus, significant number of WBC
Outcomes
Primary Outcomes
To increase the number of lungs that meet the eligibility criteria for transplantation
Time Frame: end of brain death diagnosis observation period
Secondary Outcomes
- 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)