Protective Ventilatory Strategy in Potential Organ Donors

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

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.

Study Overview

• Status: Unknown
• Conditions: Mechanical Ventilation
• Intervention / Treatment: Procedure: change ventilation

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 Type: Interventional
• Enrollment (Anticipated): 200
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: luciana mascia, MD PhD; Phone Number: 390116335600; Email: luciana.mascia@unito.it
• Study Contact Backup: Name: daniela pasero, MD; Phone Number: 390116334002; Email: dpasero@molinette.piemonte.it

Study Locations

• Italy
  • Turin, Italy, 10126
    • Recruiting
    • University of Turin, Department of Anesthesia and Intensive Care Medicine
    • Principal Investigator: Luciana Mascia, MD PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: conventional ventilation, protective ventilation	Procedure: change ventilation; reduction of tidal volume, increase of PEEP, recruiting maneuver, apnea test during CPAP

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: University of Turin, Italy
• Collaborators: Ministry of Health, Italy
• Investigators: Principal Investigator: luciana mascia, MD PhD, University of Turin, Italy; Study Director: marco ranieri, MD, University of Turin, Italy

Publications and helpful links

General Publications

• 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.

Helpful Links

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

Study record dates

Study Major Dates

• Study Start: September 1, 2004
• Primary Completion (Anticipated): September 1, 2009
• Study Completion (Anticipated): January 1, 2010

Study Registration Dates

• First Submitted: November 29, 2005
• First Submitted That Met QC Criteria: November 29, 2005
• First Posted (Estimate): December 1, 2005

Study Record Updates

• Last Update Posted (Estimate): June 17, 2009
• Last Update Submitted That Met QC Criteria: June 16, 2009
• Last Verified: June 1, 2009

More Information

Terms related to this study

• Keywords: brain death; lung transplantation; potential organ donors; organ donors
• Other Study ID Numbers: 396