Protective Ventilatory Strategy in Potential Organ Donors

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Mechanical Ventilation

Intervention / Treatment
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* Procedure: change ventilation


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: conventional ventilation, protective ventilation<br> | Procedure: change ventilation<br>* reduction of tidal volume, increase of PEEP, recruiting maneuver, apnea test during CPAP<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To increase the number of lungs that meet the eligibility criteria for transplantation |  | end of brain death diagnosis observation period | 

Secondary Outcome Measures

| Outcome Measure | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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brain death, lung transplantation, organ donors, potential organ donors