Mechanical VentilationPhase 3NCT00260676
Protective Ventilatory Strategy in Potential Organ Donors
A Phase 3 study testing change ventilation in people with Mechanical Ventilation, run by University of Turin, Italy at 1 site in Italy.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Mechanical Ventilation
- What is being tested?
- change ventilation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteItaly
- Study dates
- Sep 2004to Jan 2010
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
University of Turin, Department of Anesthesia and Intensive Care Medicine
Turin, 10126
Luciana Mascia, MD PhD
About this study
Official title: 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.
Read the 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
- Being tested
- change ventilation
- Keywords
- brain death, lung transplantation, organ donors, potential organ donors
- Medical subject headings
- Brain Death
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
change ventilationProcedure or surgery
reduction of tidal volume, increase of PEEP, recruiting maneuver, apnea test during CPAP
| Study group | Role | What they receive |
|---|---|---|
| conventional ventilation, protective ventilation | Other | Not described Receives: Procedure: change ventilation |
What is being measured
The primary outcome is the main question the study is designed to answer.
To increase the number of lungs that meet the eligibility criteria for transplantation
Measured: end of brain death diagnosis observation period
Secondary outcomes (2)
To increase the number of lungs really transplanted
Measured: end of brain death diagnosis observation period
Interim analysis at 100 subjects enrolled will be considered
Measured: six months after transplant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2005 (estimated)
- Study startSep 2004
- Primary completionSep 2009 (estimated)
- Study completionJan 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Mechanical VentilationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Turin, Italy
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Health, Italy
- Investigators
- luciana mascia, MD PhD, Principal investigator, University of Turin, Italymarco ranieri, MD, Study director, University of Turin, Italy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00260676
- Sponsor's protocol ID
- 396
- Status last verified
- Jun 2009
- First submitted
- 29 Nov 2005
- Last updated
- 17 Jun 2009
- Results posted
- No
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.
PubMed 21156950
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- a Randomised Control Trial on Protective Ventilatory Strategy in Potential Organ Donors
- ClinicalTrials.gov ID
- NCT00260676
- Acronym / sponsor ID
- 396
- Conditions
- Mechanical Ventilation
- Keywords
- brain death, lung transplantation, organ donors, potential organ donors
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- University of Turin, ItalyUniversity, hospital or other
- Collaborators
- Ministry of Health, Italy
- Study start
- Sep 2004
- Primary completion
- Sep 2009 (estimated)
- Study completion
- Jan 2010 (estimated)
- First posted
- 1 Dec 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| conventional ventilation, protective ventilation | Other | Procedure: change ventilation |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| change ventilationreduction of tidal volume, increase of PEEP, recruiting maneuver, apnea test during CPAP | Procedure or surgery | conventional ventilation, protective ventilation |
Primary outcome
To increase the number of lungs that meet the eligibility criteria for transplantation
Time frame: end of brain death diagnosis observation period
2 secondary outcomes
To increase the number of lungs really transplanted
Time frame: end of brain death diagnosis observation period
Interim analysis at 100 subjects enrolled will be considered
Time frame: six months after transplant
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2009.
- Derived from this study: PubMed 21156950Mascia 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
luciana mascia, MD PhD principal investigator
University of Turin, Italy
marco ranieri, MD study director
University of Turin, Italy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing change ventilation in people with Mechanical Ventilation, run by University of Turin, Italy at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Jun 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact luciana mascia, MD PhD (390116335600, luciana.mascia@unito.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To increase the number of lungs that meet the eligibility criteria for transplantation (time frame: end of brain death diagnosis observation period). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00260676, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jun 2009.