Clinical trial · Interventional
Non-Invasive Ventilation Preoperative Lung Resection Surgery
Evaluation of Non-Invasive Ventilation Preoperative Lung Resection Surgery
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Surgery for Primary Lung Cancer | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Manufacturer (VPAP ST) | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Manufacturer VPAP ST
- description
- 7 days minimum non-invasive ventilation at 2 levels of pressure (BPAP) to the intervention.
- interventionNames
- Device: Manufacturer (VPAP ST)
- type
- NO_INTERVENTION
- label
- No intervention
- description
- usual advice
Primary outcomes (1)
- measure
- Reduction of pulmonary complications and cardiovascular postoperative
- timeFrame
- 1 month
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 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 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: * Lack of understanding of the technical * facial malformation * 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
References
Publications (1)
- RESULTPaleiron 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. PMID 31924365