Protective Ventilatory Strategy in Potential Organ Donors

Mechanical Ventilation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Unknown status

Administrative data

• NCT number: NCT00260676
• Other study ID #: 396
• Status: Unknown status
• Phase: Phase 3
• First received: November 29, 2005
• Last updated: June 16, 2009
• Start date: September 2004
• Est. completion date: January 2010

Study information

• Verified date: June 2009
• Source: University of Turin, Italy
• Contact: luciana mascia, MD PhD
• Phone: 390116335600
• Email: luciana.mascia[@]unito.it
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Unknown status
• Enrollment: 200
• Est. completion date: January 2010
• Est. primary completion date: September 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Mechanical Ventilation

Intervention

Procedure:
• change ventilation
reduction of tidal volume, increase of PEEP, recruiting maneuver, apnea test during CPAP

Locations

Country	Name	City	State
Italy	University of Turin, Department of Anesthesia and Intensive Care Medicine	Turin

Sponsors (2)

Lead Sponsor	Collaborator
University of Turin, Italy	Ministry of Health, Italy

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To increase the number of lungs that meet the eligibility criteria for transplantation		end of brain death diagnosis observation period
Secondary	To increase the number of lungs really transplanted		end of brain death diagnosis observation period
Secondary	Interim analysis at 100 subjects enrolled will be considered		six months after transplant

External Links

•   Click here for more information about this study: Protective ventilatory strategy in potential organ donors (POPS)