Surgery for Primary Lung CancerpréOVNINCT01685580
Non-Invasive Ventilation Preoperative Lung Resection Surgery
A study testing Manufacturer (VPAP ST) in people with Surgery for Primary Lung Cancer, run by University Hospital, Brest at 15 sites in France.
Trial summary
Surgical treatment is the standard treatment for localized forms of lung cancer non-small cell. It allows a 5-year survival exceeding 50% for complete resection of the tumor. This is a heavy treatment, resulting in a mortality of 4 to 8% and a morbidity of 20-60%. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Surgery for Primary Lung Cancer
- What is being tested?
- Manufacturer (VPAP ST)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 15 sitesFrance
- Study dates
- 8 Oct 2012to 25 Oct 2017
- 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
- Patient over 18 years, to benefit from surgery scheduled for lung resection (lobectomy or segmentectomy) for primary lung cancer and having signed an informed consent.
- AND
- Trouble obstructive (FEV / FVC <70% and FEV <80% predicted)
- Or restrictive (FVC <80% or TLC <80%)
- Or decrease in the ratio TLCO / VA <60%
- Or history of respiratory failure with hypercapnic Pa CO2> 45 mmHg in the year preceding surgery
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- Or long-term oxygen
- Or heart failure (clinical signs of heart failure and LVEF <55% or disorder of relaxation on echocardiography or atrial fibrillation)
- Or history of acute cardiogenic pulmonary edema.
- Or obesity (BMI> 30 kg/m2)
Who cannot join
- Inability to consent
- Patient declared inoperable given the comorbidities or refusing surgery or with unresectable tumors.
- Patient operable but with no comorbidities described in the inclusion criteria
- Contraindications to the non-invasive ventilation:
- Lack of understanding of the technical
- facial malformation
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- Tight stenosis of the upper airway
- uncontrollable vomiting
- Unable to remove the mask
- Cognitive impairment or severe psychiatric jeopardizing the observance of the NAV
- Patient non-insured
- Patient already on invasive ventilation or non-invasive
- During Pregnancy
Trial locations and contacts
15 sites in 1 country.
15 sites in 1 country
France15 sites
Centre Hospitalier du Pays d'Aix
Aix-en-Provence, France, 13616
CHU Angers
Angers, 49933
Centre Hospitalier Victor Dupouy
Argenteuil, France, 95100
Clinqiue du Grand Large
Brest, France, 29200
CHRU de Brest - Hôpital Morvan
Brest, 29609
Inter Army Hospital, Clermont-Tonnerre
Brest, 29609
Inter Army Hospital
Clamart, 92141
CHI Créteil
Créteil, 94010
CHU Limoges
Limoges, 87042
Hospital, Pasteur
Nice, 06000
Hôpital Pontchaillou
Rennes, France, 35033
CHU de Rouen
Rouen, France, 76031
CHU Saint-Etienne
Saint-Etienne, 42055
Inter Army Hospital, Saint-Anne
Toulon, 83041
Hôpital Nord Ouest Villefranche Sur Saône
Villefranche-sur-Saône, France, 69655
About this study
Official title: Evaluation of Non-Invasive Ventilation Preoperative Lung Resection Surgery
Surgical treatment is the standard treatment for localized forms of lung cancer non-small cell. It allows a 5-year survival exceeding 50% for complete resection of the tumor. This is a heavy treatment, resulting in a mortality of 4 to 8% and a morbidity of 20-60%. Securing this procedure is a major public health issue. The non-invasive ventilation is a technique commonly used postoperatively in acute respiratory distress and in the treatment of sleep apnea syndromes. Through its effect on oxygenation and pulmonary function parameters, the non-invasive ventilation achieved during 7 days minimum before the intervention could significantly reduce postoperative complications in patients with an obstructive or restrictive disorder, obesity or chronic heart failure.
The aim of the study is to demonstrate that the non-invasive ventilation in two pressure levels achieved during at least 7 days before surgery lung resection (lobectomy or segmentectomy) halved the pulmonary and cardiovascular postoperative patients with obstructive ventilatory disorder or restrictive, obesity or chronic heart failure.
- Conditions
- Surgery for Primary Lung Cancer
- Being tested
- Manufacturer (VPAP ST)
- Keywords
- primary lung cancer, lobectomy, pneumonectomy, non-invasive ventilation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Manufacturer (VPAP ST)Device
non-invasive ventilation in two pressure levels 7 days before surgery
| Study group | Role | What they receive |
|---|---|---|
| Manufacturer VPAP ST | Experimental | 7 days minimum non-invasive ventilation at 2 levels of pressure (BPAP) to the intervention. Receives: Device: Manufacturer (VPAP ST) |
| No intervention | No intervention | usual advice |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction of pulmonary complications and cardiovascular postoperative
Demonstrate that the non-invasive ventilation in two pressure levels achieved during at least 7 days before surgery lung resection (lobectomy or segmentectomy) halved the pulmonary and cardiovascular postoperative patients with obstructive ventilatory disorder or restrictive, obesity or chronic heart failure.
Measured: 1 month
Secondary outcomes (1)
Identifying sub-groups of patients
Identify subgroups of patients benefiting most from a non-invasive ventilation preoperatively and safety of this technique preoperatively.
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2012 (estimated)
- Study start8 Oct 2012
- Primary completion25 Oct 2017
- Study completion25 Oct 2017
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 Surgery for Primary Lung CancerStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Brest
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Health, France
- Responsible party
- Sponsor
- Investigators
- Nicolas PALEIRON, MD, Principal investigator, Brest, Inter Army Hospital Clermont-Tonnerre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01685580
- Sponsor's protocol ID
- RB 11.095 préOVNI
- Acronym
- préOVNI
- Status last verified
- Sep 2018
- First submitted
- 12 Sep 2012
- Last updated
- 3 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Paleiron N, Grassin F, Lancelin C, Tromeur C, Margery J, Natale C, Couturaud F; GFPC Group. Assessment of preoperative noninvasive ventilation before lung cancer surgery: The preOVNI randomized controlled study. J Thorac Cardiovasc Surg. 2020 Oct;160(4):1050-1059.e3. doi: 10.1016/j.jtcvs.2019.09.193. Epub 2019 Nov 23.
PubMed 31924365
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Non-Invasive Ventilation Preoperative Lung Resection Surgery
- ClinicalTrials.gov ID
- NCT01685580
- Acronym / sponsor ID
- préOVNI / RB 11.095 préOVNI
- Conditions
- Surgery for Primary Lung Cancer
- Keywords
- primary lung cancer, lobectomy, pneumonectomy, non-invasive ventilation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- University Hospital, BrestUniversity, hospital or other
- Collaborators
- Ministry of Health, France
- Study start
- 8 Oct 2012 (actual)
- Primary completion
- 25 Oct 2017 (actual)
- Study completion
- 25 Oct 2017 (actual)
- First posted
- 14 Sep 2012 (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.
Surgical treatment is the standard treatment for localized forms of lung cancer non-small cell. It allows a 5-year survival exceeding 50% for complete resection of the tumor. This is a heavy treatment, resulting in a mortality of 4 to 8% and a morbidity of 20-60%. Securing this procedure is a major public health issue. The non-invasive ventilation is a technique commonly used postoperatively in acute respiratory distress and in the treatment of sleep apnea syndromes. Through its effect on oxygenation and pulmonary function parameters, the non-invasive ventilation achieved during 7 days minimum before the intervention could significantly reduce postoperative complications in patients with an obstructive or restrictive disorder, obesity or chronic heart failure.
The aim of the study is to demonstrate that the non-invasive ventilation in two pressure levels achieved during at least 7 days before surgery lung resection (lobectomy or segmentectomy) halved the pulmonary and cardiovascular postoperative patients with obstructive ventilatory disorder or restrictive, obesity or chronic heart failure.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Manufacturer VPAP ST | Experimental | Device: Manufacturer (VPAP ST)7 days minimum non-invasive ventilation at 2 levels of pressure (BPAP) to the intervention. |
| No intervention | No intervention | –usual advice |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Patient over 18 years, to benefit from surgery scheduled for lung resection (lobectomy or segmentectomy) for primary lung cancer and having signed an informed consent.
- AND
- Trouble obstructive (FEV / FVC <70% and FEV <80% predicted)
- Or restrictive (FVC <80% or TLC <80%)
- Or decrease in the ratio TLCO / VA <60%
Key exclusion criteria (13 listed)
- Inability to consent
- Patient declared inoperable given the comorbidities or refusing surgery or with unresectable tumors.
- Patient operable but with no comorbidities described in the inclusion criteria
- Contraindications to the non-invasive ventilation:
- Patient non-insured
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 |
|---|---|---|
| Manufacturer (VPAP ST)non-invasive ventilation in two pressure levels 7 days before surgery | Device | Manufacturer VPAP ST |
Primary outcome
Reduction of pulmonary complications and cardiovascular postoperative
Time frame: 1 month
Demonstrate that the non-invasive ventilation in two pressure levels achieved during at least 7 days before surgery lung resection (lobectomy or segmentectomy) halved the pulmonary and cardiovascular postoperative patients with obstructive ventilatory disorder or restrictive, obesity or chronic heart failure.
1 secondary outcome
Identifying sub-groups of patients
Time frame: 1 month
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 3 Dec 2025.
- Results publication: PubMed 31924365Paleiron N, Grassin F, Lancelin C, Tromeur C, Margery J, Natale C, Couturaud F; GFPC Group. Assessment of preoperative noninvasive ventilation before lung cancer surgery: The preOVNI randomized controlled study. J Thorac Cardiovasc Surg. 2020 Oct;160(4):1050-1059.e3. doi: 10.1016/j.jtcvs.2019.09.193. Epub 2019 Nov 23.
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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.
Nicolas PALEIRON, MD principal investigator
Brest, Inter Army Hospital Clermont-Tonnerre
15 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Manufacturer (VPAP ST) in people with Surgery for Primary Lung Cancer, run by University Hospital, Brest at 15 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 10 inclusion and 13 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 3 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 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.
What does the primary outcome measure?
Reduction of pulmonary complications and cardiovascular postoperative (time frame: 1 month). 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 NCT01685580, 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 3 Dec 2025.