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| Name | Class |
|---|---|
| Ministry of Health, France | OTHER_GOV |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Manufacturer VPAP ST | Experimental | 7 days minimum non-invasive ventilation at 2 levels of pressure (BPAP) to the intervention. |
|
| No intervention | No Intervention | usual advice |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Manufacturer (VPAP ST) | Device | non-invasive ventilation in two pressure levels 7 days before surgery |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 1 month |
| Measure | Description | Time Frame |
|---|---|---|
| Identifying sub-groups of patients | Identify subgroups of patients benefiting most from a non-invasive ventilation preoperatively and safety of this technique preoperatively. | 1 month |
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Inclusion Criteria:
AND
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
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)
Exclusion Criteria:
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
Patient already on invasive ventilation or non-invasive
During Pregnancy
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| Name | Affiliation | Role |
|---|---|---|
| Nicolas PALEIRON, MD | Brest, Inter Army Hospital Clermont-Tonnerre | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre Hospitalier du Pays d'Aix | Aix-en-Provence | France | 13616 | France | ||
| Centre Hospitalier Victor Dupouy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31924365 | Result | 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. |
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| Argenteuil |
| France |
| 95100 |
| France |
| Clinqiue du Grand Large | Brest | France | 29200 | France |
| Hôpital Pontchaillou | Rennes | France | 35033 | France |
| CHU de Rouen | Rouen | France | 76031 | France |
| Hôpital Nord Ouest Villefranche Sur Saône | Villefranche-sur-Saône | France | 69655 | France |
| CHU Angers | Angers | 49933 | France |
| CHRU de Brest - Hôpital Morvan | Brest | 29609 | France |
| Inter Army Hospital, Clermont-Tonnerre | Brest | 29609 | France |
| Inter Army Hospital | Clamart | 92141 | France |
| CHI Créteil | Créteil | 94010 | France |
| CHU Limoges | Limoges | 87042 | France |
| Hospital, Pasteur | Nice | 06000 | France |
| CHU Saint-Etienne | Saint-Etienne | 42055 | France |
| Inter Army Hospital, Saint-Anne | Toulon | 83041 | France |