NCT00260676

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Sep 2004

Longer than P75 for phase_3

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2004

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

November 29, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 1, 2005

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2009

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2010

Completed
Last Updated

June 17, 2009

Status Verified

June 1, 2009

Enrollment Period

5 years

First QC Date

November 29, 2005

Last Update Submit

June 16, 2009

Conditions

Mechanical Ventilation

Keywords

brain deathlung transplantationorgan donorspotential organ donors

Outcome Measures

Primary Outcomes (1)

  • To increase the number of lungs that meet the eligibility criteria for transplantation

    end of brain death diagnosis observation period

Secondary Outcomes (2)

  • 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

Study Arms (1)

conventional ventilation, protective ventilation

OTHER
Procedure: change ventilation

Interventions

change ventilationPROCEDURE

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

conventional ventilation, protective ventilation

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Turin, Department of Anesthesia and Intensive Care Medicine

Turin, 10126, Italy

RECRUITING

Related Publications (1)

  • 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.

    PMID: 21156950DERIVED

MeSH Terms

Conditions

Brain Death

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesComaUnconsciousnessConsciousness DisordersNeurobehavioral ManifestationsNeurologic ManifestationsDeathPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • luciana mascia, MD PhD

    University of Turin, Italy

    PRINCIPAL INVESTIGATOR

  • marco ranieri, MD

    University of Turin, Italy

    STUDY DIRECTOR

Central Study Contacts

luciana mascia, MD PhD

CONTACT

390116335600luciana.mascia@unito.it

daniela pasero, MD

CONTACT

390116334002dpasero@molinette.piemonte.it

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 29, 2005

First Posted

December 1, 2005

Study Start

September 1, 2004

Primary Completion

September 1, 2009

Study Completion

January 1, 2010

Last Updated

June 17, 2009

Record last verified: 2009-06

Locations

IT(1)