Manufacturer (VPAP ST)
Devicenon-invasive ventilation in two pressure levels 7 days before surgery
NCT Number: NCT01685580
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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Notify Me18 year and older
All sexes
Interventional
Not applicable
Centre Hospitalier du Pays d'Aix, Aix-en-Provence, France
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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
non-invasive ventilation in two pressure levels 7 days before surgery
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.
Time frame: 1 month
Identify subgroups of patients benefiting most from a non-invasive ventilation preoperatively and safety of this technique preoperatively.
University Hospital, Brest
Other
Evaluation of Non-Invasive Ventilation Preoperative Lung Resection Surgery
Acronym: préOVNI
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.