High-Flow in Hypercapnic Stable COPD Patients
- Conditions
- Adherence, Treatment
- Interventions
- Device: Non Invasive VentilationDevice: Nasal High Flow installationOther: Training sessionOther: Education session
- Registration Number
- NCT04281316
- Lead Sponsor
- University Hospital, Grenoble
- Brief Summary
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
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.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 3
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Nasal High Flow (MyAirvo) device group Training session The patients in the NHF arm will receive NHF treatment and two hours training adaptation session will be conducted in the hospital. Non Invasive Ventilation device group Non Invasive Ventilation 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. Nasal High Flow (MyAirvo) device group Nasal High Flow installation The patients in the NHF arm will receive NHF treatment and two hours training adaptation session will be conducted in the hospital. Non Invasive Ventilation device group Education session 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.
- Primary Outcome Measures
Name Time Method Changes on nocturnal parameters with the nasal high-flow (NHF) compared to non-invasive ventilation in patients with a COPD-related hypercapnic respiratory failure. between night at day 1 (baseline) and night at day 90 (3 months after) Differences in mean overnight transcutaneous PtCO2 measurement
- Secondary Outcome Measures
Name Time Method Treatment adherence between night at day 1 (baseline) and night at day 90 (3 months after) Treatment adherence measured objectively by download of NIV software data and for NHF (myAirvo2) by hour meter \& daily average of usage (screen display)
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. between night at day 1 (baseline) and night at day 90 (3 months after) Maximum PtCO2
Cardiovasculary function between day 0 and day 97 Blood pressure measurements will be done three times during rest at five minutes intervals to provide informations on systolic, diastolic and mean blood pressure
Daytime blood gas values in ambient air between day 0 (inclusion) and day 97 (end of the study) PaCO2 \& PaO2 in ambient air will be measured by blood gas sample in NHF group compared de NIV group
Other nocturnal parameter between night at day 1 (baseline) and night at day 90 (3 months after) 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.
Physical activity for 7 days from the day 1 and for 7 days from the day 90 An actimetry will allow evaluating physical activity (number of steps)
Health related quality of life between day 0 and day 97 Subjective functioning and quality of life will be measured by self-reporting questionnaire SGRQ
Sleep activity between night at day 1 (baseline) and night at day 90 (3 months after) An actimetry will allow evaluating sleep efficiency
Pulmonary function tests between day 0 and day 97 Pulmonary function will be evaluated by routine patient care spirometry and will measure Forced expiratory volume (FEV) in liters
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 between day 0 and day 97 All safety data will be recorded through an Electronic Medical Record as reported by the patient or recorded by the research nurse
Trial Locations
- Locations (1)
Grenoble Alpes University Hospital
🇫🇷Grenoble, France