An interventional study of Nasal High Flow installation and Non Invasive Ventilation in Adherence, Treatment, sponsored by University Hospital, Grenoble. Terminated at 1 site in France. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2022-05-24.
Sponsored by University Hospital, Grenoble · Not applicable, Interventional, and Treatment
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.
University Hospital, Grenoble is the lead sponsor of 815 studies on the registry; 205 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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 · Other: Education session
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 · Other: Training session
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
Also known as: MyAirvo Device
Participants randomized in the Non Invasive Ventilation group will receive treatment as in their usual care.
The patients in the Nasal High Flow (MyAirvo) arm will receive two hours training adaptation session in the hospital
Participants randomized in the Non Invasive Ventilation group will receive an additional educational session of one hour for improving compliance.
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
Time frame: between night at day 1 (baseline) and night at day 90 (3 months after)
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
Time frame: 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)
Time frame: 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
Time frame: 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.
Time frame: 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)
Time frame: 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
Time frame: 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
Time frame: between night at day 1 (baseline) and night at day 90 (3 months after)
Sleep activity
An actimetry will allow evaluating sleep efficiency
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: between day 0 and day 97
Plan to share: No
This study is terminated, as verified in May 2022. You cannot join it, but the record below documents what was studied.
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University Hospital, Grenoble