Protective Ventilatory Strategy in Potential Organ Donors

NCT ID: NCT00260676

Last Updated: 2009-06-17

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE3
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-09-30
• Study Completion Date: 2010-01-31

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.

Conditions

Mechanical Ventilation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

conventional ventilation, protective ventilation

Group Type: OTHER

change ventilation

Intervention Type: PROCEDURE

reduction of tidal volume, increase of PEEP, recruiting maneuver, apnea test during CPAP

Interventions

change ventilation

reduction of tidal volume, increase of PEEP, recruiting maneuver, apnea test during CPAP

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ministry of Health, Italy

OTHER_GOV

Sponsor Role: collaborator

University of Turin, Italy

OTHER

Sponsor Role: lead

Responsible Party

University of Turin, Italy

Principal Investigators

luciana mascia, MD PhD

Role: PRINCIPAL_INVESTIGATOR

University of Turin, Italy

marco ranieri, MD

Role: STUDY_DIRECTOR

University of Turin, Italy

Locations

University of Turin, Department of Anesthesia and Intensive Care Medicine

Turin, , Italy

Site Status: RECRUITING

Countries

Italy

Central Contacts

luciana mascia, MD PhD

Role: CONTACT

luciana.mascia@unito.it

390116335600

daniela pasero, MD

Role: CONTACT

dpasero@molinette.piemonte.it

390116334002

References

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.

Reference Type: DERIVED

PMID: 21156950 (View on PubMed)

Other Identifiers

396

Identifier Type: -

Identifier Source: org_study_id