Non-Invasive Ventilation Preoperative Lung Resection Surgery (préOVNI)

This study is currently recruiting participants.
Verified March 2014 by University Hospital, Brest
Sponsor:
Collaborator:
Ministry of Health, France
Information provided by (Responsible Party):
University Hospital, Brest
ClinicalTrials.gov Identifier:
NCT01685580
First received: September 12, 2012
Last updated: March 31, 2014
Last verified: March 2014

September 12, 2012
March 31, 2014
October 2012
February 2015   (final data collection date for primary outcome measure)
Reduction of pulmonary complications and cardiovascular postoperative [ Time Frame: 1 month ] [ Designated as safety issue: Yes ]
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.
Same as current
Complete list of historical versions of study NCT01685580 on ClinicalTrials.gov Archive Site
Identifying sub-groups of patients [ Time Frame: 1 month ] [ Designated as safety issue: Yes ]
Identify subgroups of patients benefiting most from a non-invasive ventilation preoperatively and safety of this technique preoperatively.
Same as current
Not Provided
Not Provided
 
Non-Invasive Ventilation Preoperative Lung Resection Surgery
Evaluation of Non-Invasive Ventilation Preoperative Lung Resection Surgery

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Surgery for Primary Lung Cancer
Device: Manufacturer (VPAP ST)
non-invasive ventilation in two pressure levels 7 days before surgery
  • Experimental: Manufacturer VPAP ST
    7 days minimum non-invasive ventilation at 2 levels of pressure (BPAP) to the intervention.
    Intervention: Device: Manufacturer (VPAP ST)
  • No Intervention: No intervention
    usual advice
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
300
February 2015
February 2015   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact: Nicolas PALEIRON, MD +33298437301 nicolas.paleiron@free.fr
France
 
NCT01685580
RB 11.095 préOVNI
Yes
University Hospital, Brest
University Hospital, Brest
Ministry of Health, France
Principal Investigator: Nicolas PALEIRON, MD Brest, Inter Army Hospital Clermont-Tonnerre
University Hospital, Brest
March 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP