High-Flow in Hypercapnic Stable COPD Patients
High-Flow in Hypercapnic Stable COPD Patients
Monocentric, prospective, open, randomized 1:1, controlled study to evaluate the impact of
 nasal high-flow (NHF) on nocturnal transcutaneous PCO2 (PtCO2) compared to non-invasive
 ventilation ± Long-Term Oxygen Therapy (LTOT) in patients with a Chronic obstructive
 pulmonary disease (COPD)-related hypercapnic respiratory failure.
Chronic obstructive pulmonary disease (COPD) is a growing global health concern, causing
 considerable health-related costs and increased mortality. COPD is nowadays considered a
 complex, heterogeneous and systemic condition.

 In the late stage of the disease, non-invasive ventilation (NIV) is widely prescribed either
 to treat acute hypercapnic respiratory failure during COPD exacerbations or for long term
 home management.

 A meta-analysis has shown that higher daytime PaCO2 occurred in home NIV treated COPD
 patients when NIV compliance is less than 5 h/day. Thus, an optimal NIV adherence is a key
 target for controlling nocturnal and diurnal hypoventilation and improving prognosis.

 COPD is the clinical scenario during which a good NIV adherence is difficult to achieve.
 Particularly, in COPDs exhibiting hyperinflation, NIV can aggravate dynamic hyperinflation
 resulting in unrewarded inspiratory efforts, poor sleep and low NIV compliance. Alternatives
 to NIV are then desirable in this specific subgroup of hypercapnic COPD with poor adherence
 to NIV.

 During this trial, stable COPD patients treated by long term home Non-Invasive Ventilation
 (NIV) treatment following French national recommendations and exhibiting a NIV compliance of
 (less than 5 hours and more than 1 hour) per day in the last 3 months prior to inclusion will
 be randomized via a secure electronic website to either continue with their current NIV
 treatment or receive the nasal high flow (NHF) treatment delivered by myAirvo2 during 3
 months Nasal High-Flow (NHF) is a treatment delivering heated, humidified, and optionally
 oxygen-enriched air at high flow rates through a nasal cannula. The main physiologic effects
 of NHF are an improvement in gas exchanges including a reduction in hypercapnia, an
 optimization in breathing patterns with a reduction of work of breathing. Nasal High-Flow
 (NHF) is delivered via a comfortable nasal interface and has demonstrated good treatment
 adherence.

 The investigators hypothesize that in COPD-related hypercapnic chronic respiratory failure
 with limited compliance to NIV (less than 5 hours per night), nasal High-Flow (NHF) will be
 non-inferior for controlling nocturnal hypoventilation and might improve daytime subjective
 patients centered outcomes, physical activity and nocturnal adherence to treatment.
Inclusion Criteria:

 -  Diagnosed with COPD (FEV1/FVC < 70%) and long term indication for home NIV for
 initiated at least 3 months prior the inclusion.

 -  Compliance with NIV (less than 5 hours and more than 1 hour) per night on average
 during the last 3 months prior to inclusion.

 -  Naïve to Nasal High Flow (NHF) therapy, i.e. having not used NHF in the last 6 months
 prior to inclusion.

 -  Able to understand, follow objectives and methods of protocol in French language.

 -  Patient affiliated to social security insurance or beneficiary of social health
 insurance.

 -  Willing and able to give written Informed Consent and to comply with the requirements
 of the study protocol.

 Exclusion Criteria:

 -  Significant uncontrolled cardiac disease (investigator judgment), and/or Left
 Ventricular Ejection Fraction (LVEF) < 45%.

 -  Known co-existing obstructive sleep apnea requiring expiratory pressure above 6 cmH20.

 -  Severe nasal obstruction, previous upper airway surgery preventing the usage of NHF,
 or, at the discretion of investigator, any other contraindication for using the NHF.

 -  Patients who are unable or unwilling to give informed consent.

 -  Participating in another research study.

 -  Patient protected by the Law, under guardianship or curators.

 -  Pregnancy and nursing mothers

 -  Patient not covered by a health insurance.