Non-Invasive Ventilation Preoperative Lung Resection Surgery

NCT ID: NCT01685580

Last Updated: 2025-12-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 300 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-10-08
• Study Completion Date: 2017-10-25

Brief 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%. 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Manufacturer VPAP ST

7 days minimum non-invasive ventilation at 2 levels of pressure (BPAP) to the intervention.

Group Type: EXPERIMENTAL

Manufacturer (VPAP ST)

Intervention Type: DEVICE

non-invasive ventilation in two pressure levels 7 days before surgery

No intervention

usual advice

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Manufacturer (VPAP ST)

non-invasive ventilation in two pressure levels 7 days before surgery

Intervention Type: DEVICE

Eligibility Criteria

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)

• 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

Exclusion Criteria

• Inability to consent
• Patient declared inoperable given the comorbidities or refusing surgery or with unresectable tumors.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ministry of Health, France

OTHER_GOV

Sponsor Role: collaborator

University Hospital, Brest

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Nicolas PALEIRON, MD

Role: PRINCIPAL_INVESTIGATOR

Brest, Inter Army Hospital Clermont-Tonnerre

Locations

Centre Hospitalier du Pays d'Aix

Aix-en-Provence, France, France

Centre Hospitalier Victor Dupouy

Argenteuil, France, France

Clinqiue du Grand Large

Brest, France, France

Hôpital Pontchaillou

Rennes, France, France

CHU de Rouen

Rouen, France, France

Hôpital Nord Ouest Villefranche Sur Saône

Villefranche-sur-Saône, France, France

CHU Angers

Angers, , France

CHRU de Brest - Hôpital Morvan

Brest, , France

Inter Army Hospital, Clermont-Tonnerre

Brest, , France

Inter Army Hospital

Clamart, , France

CHI Créteil

Créteil, , France

CHU Limoges

Limoges, , France

Hospital, Pasteur

Nice, , France

CHU Saint-Etienne

Saint-Etienne, , France

Inter Army Hospital, Saint-Anne

Toulon, , France

Countries

France

References

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.

Reference Type: RESULT

PMID: 31924365 (View on PubMed)

Other Identifiers

RB 11.095 préOVNI

Identifier Type: -

Identifier Source: org_study_id