Protective Ventilatory Strategy in Potential Organ Donors

Phase 3

• Conditions: Mechanical Ventilation
• Interventions: Procedure: change ventilation

• Registration Number: NCT00260676
• Lead Sponsor: University of Turin, Italy

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.

Study Timeline

• Study Start: 2004-09
• Study First Submitted: 2005-11-29
• Study First Submitted QC: 2005-11-29
• Study First Posted: 2005-12-01
• Status Verified: 2009-06
• Last Update Submitted: 2009-06-16
• Last Update Posted: 2009-06-17
• Primary Completion: 2009-09
• Study Completion: 2010-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
conventional ventilation, protective ventilation	change ventilation	-

Primary Outcome Measures

Name	Time	Method
To increase the number of lungs that meet the eligibility criteria for transplantation	end of brain death diagnosis observation period

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

University of Turin, Department of Anesthesia and Intensive Care Medicine; 🇮🇹 Turin, Italy