COPDPOPVNINCT00428857
Noninvasive Ventilatory Support After Lung Surgery in COPD Patients
A study testing non invasive ventilation in people with COPD and Post Pulmonary Resection, run by Assistance Publique - Hôpitaux de Paris at 7 sites in France.
Trial summary
Rationale: respiratory complications are the most frequent complications following lung resection and represent a noticeable cause of mortality. Benefits from non-invasive ventilation (NIV) in acute respiratory failure are now clearly demonstrated. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COPD, Post Pulmonary Resection
- What is being tested?
- non invasive ventilation
- Type of treatment
- Surgery or procedure
- How many people
- 360 participants
- Where
- 7 sitesFrance
- Study dates
- Jun 2008to Oct 2010
- Phase
- Interventional
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with COPD (FEV1 pre-operative <80% and FEV1/CV<70%)
- Patients undergoig pulmonary resection
- Informed consent
Who cannot join
- Apnea syndrom and chronic noninvasive support
- Post-operative extrarespiratory organ failure
- Inhability to follow study protocole
- Absence of medical coverage
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
France7 sites
Hopital Du Bocage
Dijon, Dijon, 21034
HEGP
Paris, Paris, 75015
Hotel Dieu
Paris, 75004
Institut Mutualiste Montsouris
Paris, 75014
hopital de Pontoise
Pontoise, Pontoise
CHU strasbourg
Strasbourg, Strasbourg
CHU Larrey
Toulouse, 31049
About this study
Official title: Noninvasive Ventilatory Support After Lung Surgery to Prevent Pulmonary Complications in COPD Patients
Rationale: respiratory complications are the most frequent complications following lung resection and represent a noticeable cause of mortality. Benefits from non-invasive ventilation (NIV) in acute respiratory failure are now clearly demonstrated. The use of preventive NIV after lung resection, in the absence of acute respiratory failure and/or hypercarbia, could be justified by the physiological benefits expected. The goal of this study is to assess the efficacy of post-operative NIV in moderate-to-severe COPD, for prevention of respiratory complications.
Material and Methods: This is a prospective randomised multicenter trial with an open parallel design in moderate-t-o-severe COPD patients hospitalised in thoracic surgery for lung resection.
Read more
Expected results: This study will determine whether post-operative NIV decreases the incidence of acute respiratory events (acute respiratory failure) and whether some subgroups of patients benefit more from this strategy.
Conclusion: This study should help evaluating the utility of post-operative NIV after lung resection.
- Conditions
- COPD, Post Pulmonary Resection
- Being tested
- non invasive ventilation
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
non invasive ventilationProcedure or surgery
non invasive ventilation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2007 (estimated)
- Study startJun 2008
- Primary completionOct 2010
- Study completionOct 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COPDStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 360 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Investigators
- christine lorut, MD, Principal investigator, APHPantoine rabbat, MD, Principal investigator, APHP
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00428857
- Sponsor's protocol ID
- P070501
- Acronym
- POPVNI
- Status last verified
- Jan 2007
- First submitted
- 29 Jan 2007
- Last updated
- 24 Feb 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Noninvasive Ventilatory Support After Lung Surgery to Prevent Pulmonary Complications in COPD Patients
- ClinicalTrials.gov ID
- NCT00428857
- Acronym / sponsor ID
- POPVNI / P070501
- Conditions
- COPD, Post Pulmonary Resection
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 360 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- Jun 2008
- Primary completion
- Oct 2010 (actual)
- Study completion
- Oct 2010 (actual)
- First posted
- 30 Jan 2007 (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.
Rationale: respiratory complications are the most frequent complications following lung resection and represent a noticeable cause of mortality. Benefits from non-invasive ventilation (NIV) in acute respiratory failure are now clearly demonstrated. The use of preventive NIV after lung resection, in the absence of acute respiratory failure and/or hypercarbia, could be justified by the physiological benefits expected. The goal of this study is to assess the efficacy of post-operative NIV in moderate-to-severe COPD, for prevention of respiratory complications.
Material and Methods: This is a prospective randomised multicenter trial with an open parallel design in moderate-t-o-severe COPD patients hospitalised in thoracic surgery for lung resection.
Expected results: This study will determine whether post-operative NIV decreases the incidence of acute respiratory events (acute respiratory failure) and whether some subgroups of patients benefit more from this strategy.
Conclusion: This study should help evaluating the utility of post-operative NIV after lung resection.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients with COPD (FEV1 pre-operative <80% and FEV1/CV<70%)
- Patients undergoig pulmonary resection
- Informed consent
Key exclusion criteria (4 listed)
- Apnea syndrom and chronic noninvasive support
- Post-operative extrarespiratory organ failure
- Inhability to follow study protocole
- Absence of medical coverage
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 |
|---|---|---|
| non invasive ventilationnon invasive ventilation | Procedure or surgery | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2011.
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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.
christine lorut, MD principal investigator
APHP
antoine rabbat, MD principal investigator
APHP
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing non invasive ventilation in people with COPD and Post Pulmonary Resection, run by Assistance Publique - Hôpitaux de Paris at 7 sites in France.
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 3 inclusion and 4 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: finished, as of the sponsor's last update on 24 Feb 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in France. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
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 24 Feb 2011.