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Protective Ventilatory Strategy in Potential Organ Donors

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

Status
UNKNOWN
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00260676
Enrollment
200
Registered
2005-12-01
Start date
2004-09-30
Completion date
2010-01-31
Last updated
2009-06-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Mechanical Ventilation

Keywords

brain death, lung transplantation, organ donors, potential organ donors

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.

Interventions

PROCEDUREchange ventilation

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

Sponsors

Ministry of Health, Italy
CollaboratorOTHER_GOV
University of Turin, Italy
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
To increase the number of lungs that meet the eligibility criteria for transplantationend of brain death diagnosis observation period

Secondary

MeasureTime frame
To increase the number of lungs really transplantedend of brain death diagnosis observation period
Interim analysis at 100 subjects enrolled will be consideredsix months after transplant

Countries

Italy

Contacts

Primary Contactluciana mascia, MD PhD
luciana.mascia@unito.it390116335600
Backup Contactdaniela pasero, MD
dpasero@molinette.piemonte.it390116334002

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 30, 2026