Non-Invasive Ventilation Preoperative Lung Resection Surgery

Not Applicable

Completed

• Conditions: Surgery for Primary Lung Cancer
• Interventions: Device: Manufacturer (VPAP ST)

• Registration Number: NCT01685580
• Lead Sponsor: University Hospital, Brest

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-09-12
• Study First Submitted QC: 2012-09-12
• Study First Posted: 2012-09-14
• Study Start: 2012-10-08
• Primary Completion: 2017-10-25
• Study Completion: 2017-10-25
• Status Verified: 2018-09
• Last Update Submitted: 2018-09-28
• Last Update Posted: 2018-10-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 300

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Manufacturer VPAP ST	Manufacturer (VPAP ST)	7 days minimum non-invasive ventilation at 2 levels of pressure (BPAP) to the intervention.

Primary Outcome Measures

Name	Time	Method
Reduction of pulmonary complications and cardiovascular postoperative	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.

Secondary Outcome Measures

Name	Time	Method
Identifying sub-groups of patients	1 month	Identify subgroups of patients benefiting most from a non-invasive ventilation preoperatively and safety of this technique preoperatively.

Trial Locations

Locations (15)

Inter Army Hospital; 🇫🇷 Clamart, France

Hôpital Pontchaillou; 🇫🇷 Rennes, France

CHU Saint-Etienne; 🇫🇷 Saint-Etienne, France

CHI Créteil; 🇫🇷 Créteil, France

CHU Limoges; 🇫🇷 Limoges, France

Hospital, Pasteur; 🇫🇷 Nice, France

Inter Army Hospital, Saint-Anne; 🇫🇷 Toulon, France

Centre Hospitalier du Pays d'Aix; 🇫🇷 Aix en Provence, France

CHU de Rouen; 🇫🇷 Rouen, France

Hôpital Nord Ouest Villefranche Sur Saône; 🇫🇷 Villefranche sur Saône, France

CHU Angers; 🇫🇷 Angers, France

Centre Hospitalier Victor Dupouy; 🇫🇷 Argenteuil, France

Clinqiue du Grand Large; 🇫🇷 Brest, France

CHRU de Brest - Hôpital Morvan; 🇫🇷 Brest, France

Inter Army Hospital, Clermont-Tonnerre; 🇫🇷 Brest, France