Innovation in NOn Invasive Ventilation in COPD Patients Treated by Long Term Oxygen Therapy
Innovation in NOn Invasive Ventilation in COPD Patients Treated by Long Term Oxygen Therapy
The aim of this study is to investigate the efficacy of non-invasive ventilation (NIV) on
 nocturnal hypoventilation in patients with chronic obstructive pulmonary disease (COPD) who
 are on long term oxygen therapy (LTOT) at home.
This is a prospective, randomized, open labelled study. The primary outcome is nocturnal
 transcutaneous CO2 (PtCO2) after 3 months of non-invasive ventilation. Three hundred COPD
 patients on LTOT will be screened and assessed by pulmonary function tests, blood gases and
 nocturnal PtCO2 at their home. This will allow the determination of the prevalence of
 nocturnal hypoventilation in COPD patients on LTOT (a secondary outcome) and to select
 patients who meet the inclusion criteria for the RCT and randomization to NIV + LTOT or to
 continue LTOT alone (n=38). Patients will undergo the same assessments at the end of the
 three-month intervention period.
Inclusion Criteria:

 -  chronic obstructive pulmonary disease (COPD)

 -  on long term oxygen therapy (LTOT)

 -  affiliated to French social security system or equivalent

 -  informed consent signed

 Exclusion Criteria:

 -  Diurnal PtCO2 >55mmHg

 -  Patient who has had an exacerbation of COPD requiring a change in management or
 treatment in the last 4 weeks prior to the inclusion visit.

 -  Pregnant or breathfeeding women

 -  Prisonners or persons who require protection by the law

 -  Exclusion period from another study

 -  Persons who, according to the investigator, are expected no to meet all study
 obligations