Non-Invasive Ventilation Preoperative Lung Resection Surgery

NCT01685580 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 300

Last updated 2025-12-03

No results posted yet for this study

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

Interventions

DEVICE

Manufacturer (VPAP ST)

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

Sponsors & Collaborators

  • Ministry of Health, France

    collaborator OTHER_GOV
  • University Hospital, Brest

    lead OTHER

Principal Investigators

  • Nicolas PALEIRON, MD · Brest, Inter Army Hospital Clermont-Tonnerre

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-10-08
Primary Completion
2017-10-25
Completion
2017-10-25

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01685580 on ClinicalTrials.gov