High-Flow in Hypercapnic Stable COPD Patients

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Impact of Nasal High Flow (NHF) Versus Home Non-invasive Ventilation (NIV) on Nocturnal Transcutaneous PCO2 (PtCO2) in Stable COPD Patients: A Non-inferiority Study

Conditions
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Adherence, Treatment

Intervention / Treatment
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* Device: Nasal High Flow installation
* Device: Non Invasive Ventilation
* Other: Training session
* Other: Education session


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Non Invasive Ventilation device group<br>The patients in the NIV arm will receive treatment as in their usual care with an additional educational session of one hour for improving compliance. | Device: Non Invasive Ventilation<br>* Participants randomized in the Non Invasive Ventilation group will receive treatment as in their usual care.<br>Other: Education session<br>* Participants randomized in the Non Invasive Ventilation group will receive an additional educational session of one hour for improving compliance.<br>|
| Experimental: Nasal High Flow (MyAirvo) device group<br>The patients in the NHF arm will receive NHF treatment and two hours training adaptation session will be conducted in the hospital. | Device: Nasal High Flow installation<br>* Participants randomized in NHF group will receive the nasal high flow (NHF) treatment delivered by myAirvo2. Nasal High-Flow (NHF) is a treatment delivering heated, humidified, and optionally oxygen-enriched, air at high flow rates through a nasal cannula. The physiologic effects of NHF are an improvement in gas exchanges including a reduction in hypercarbia an optimization in breathing patterns with a reduction of work of breathing and high compliance as delivered via a comfortable nasal interface<br>* Other names: MyAirvo Device;Other: Training session<br>* The patients in the Nasal High Flow (MyAirvo) arm will receive two hours training adaptation session in the hospital<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes on nocturnal parameters with the nasal high-flow (NHF) compared to non-invasive ventilation in patients with a COPD-related hypercapnic respiratory failure. | Differences in mean overnight transcutaneous PtCO2 measurement | between night at day 1 (baseline) and night at day 90 (3 months after) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation the impact of nasal high-flow (NHF) on other nocturnal parameters compared to non-invasive ventilation ± LTOT compared to non-invasive ventilation in patients with a COPD-related hypercapnic respiratory failure. | Maximum PtCO2 | between night at day 1 (baseline) and night at day 90 (3 months after) | 
| Treatment adherence | Treatment adherence measured objectively by download of NIV software data and for NHF (myAirvo2) by hour meter & daily average of usage (screen display) | between night at day 1 (baseline) and night at day 90 (3 months after) | 
| Daytime blood gas values in ambient air | PaCO2 & PaO2 in ambient air will be measured by blood gas sample in NHF group compared de NIV group | between day 0 (inclusion) and day 97 (end of the study) | 
| Other nocturnal parameter | Overnight Sp02 will be evaluated by nocturnal oximetry at home in order to determine: mean nocturnal SaO2, nadir nocturnal SaO2, cumulative time spent below 90% of SaO2 (CT<90%), Oxygen Desaturation Index. | between night at day 1 (baseline) and night at day 90 (3 months after) | 
| Physical activity | An actimetry will allow evaluating physical activity (number of steps) | for 7 days from the day 1 and for 7 days from the day 90 | 
| Sleep activity | An actimetry will allow evaluating total sleep time in minutes | between night at day 1 (baseline) and night at day 90 (3 months after) | 
| Sleep activity | An actimetry will allow evaluating sleep onset latency in minutes | between night at day 1 (baseline) and night at day 90 (3 months after) | 
| Sleep activity | An actimetry will allow evaluating sleep efficiency | between night at day 1 (baseline) and night at day 90 (3 months after) | 
| Pulmonary function tests | Pulmonary function will be evaluated by routine patient care spirometry and will measure Vital capacity (VC) in liters | between day 0 and day 97 | 
| Pulmonary function tests | Pulmonary function will be evaluated by routine patient care spirometry and will measure Forced vital capacity (FVC) in liters | between day 0 and day 97 | 
| Pulmonary function tests | Pulmonary function will be evaluated by routine patient care spirometry and will measure Forced expiratory volume (FEV) in liters | between day 0 and day 97 | 
| Health related quality of life | Subjective functioning and quality of life will be measured by self-reporting questionnaire EQ-5D-5L | between day 0 and day 97 | 
| Health related quality of life | Subjective functioning and quality of life will be measured by self-reporting questionnaire SGRQ | between day 0 and day 97 | 
| Cardiovasculary function | Blood pressure measurements will be done three times during rest at five minutes intervals to provide informations on systolic, diastolic and mean blood pressure | between day 0 and day 97 | 
| Number of participants with adverse events will be assessed in each group by interrogating patients in order to assess the safety of nasal high-flow (NHF) treatment | All safety data will be recorded through an Electronic Medical Record as reported by the patient or recorded by the research nurse | between day 0 and day 97 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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non-compliance, NIV, NHF, COPD, hypercapnic respiratory failure