Chronic obstructive pulmonary disease (COPD) Respiratory Other chronic obstructive pulmonary disease
Conditions
Interventions
Treatment group will receive standard optimal care plus NPPV with AVAPS support, ventilatory support function that dynamically determines the pressure support level, which generates the target or cont
Sponsors
Respironics International, Inc. (France)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Both males and females, aged 50 - 80 years 2. Confirmed diagnosis of COPD according to the joint recommendations of the European Respiratory Society/American Thoracic Society (ERS/ATS) 3. Minimum of 48 hours without NPPV after using NPPV or invasive ventilation in hospital during an acute exacerbation of COPD 4. Persistent hypercapnia (partial pressure of carbon dioxide in the arterial blood [PaCO2] greater than or equal to 50 mmHg, but less than 65 mmHg with an arterial pH above 7.32) during room air spontaneous breathing 5. Able to follow instructions 6. Able to provide informed consent
Exclusion criteria
Exclusion criteria: 1. Actively smoking 2. Therapy with systemic steroids 3. Important concomitant chronic systemic diseases (i.e. chronic heart failure [left ventricular ejection fraction less than 45%], diabetes, infections, neoplasm, forms of sleep disordered breathing, etc) 4. Other chronic respiratory diseases (e.g., significant fibrothorax, bronchiectasis, cystic fibrosis)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Daytime PCO2, measured by arterial blood gases at baseline, 1, 3, 6 months and 1 year 2. Endothelial dysfunction, measured by peripheral arterial tone (PAT) at baseline, 1, 3, 6 months and 1 year | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Lung function, measured by spirometry, according to the joint recommendations of the ERS/ATS. Timepoints of assessment: baseline, 1, 3, 6 months and 1 year 2. Dyspnoea, measured at rest by the Borg scale. Timepoints of assessment: baseline, 1, 3, 6 months and 1 year. 3. Fatigue, measured by Fatigue Severity Scale (FSS). The FSS questionnaires contains nine statements that rate the severity of the subject's fatigue symptoms an a scale from 1 to 7. A total score of less than 36 suggests that the subject may not be suffering from fatigue, while a score of greater than or equal to 36 indicates excessive fatigue. Timepoints of assessment: baseline, 1, 3, 6 months and 1 year. 4. Sleep quality, measured by polysomnography (PSG), including transcutaneous PCO2. At baseline, PSG will be performed in spontaneous breathing in order to characterise the abnormal respiratory events associated with COPD and identify obstructive sleep apnoea (OSA). Sleep and respiratory events will be recorded and scored manually according to standard criteria. REM hypoventilation will be scored when a progressive oxygen desaturation is associated with a sustained reduction in both flow and thoracic components of ventilation. During the same period, a constant or reduced respiratory drive (assessed by a reduction in respiratory effort as demonstrated by pulse transit time) should be observed without characteristic apnoeic or hypopnoeic episodes. At 3 months and 1 year, polysomnography will be done in spontaneous breathing or using non-invasive ventilation depending the arm of the study. Timepoints of assessment: baseline, 3 months and 1 year. 5. Objective sleepiness as measured by the Osler Test. This test consists of a 40 minutes sleep-resistance challenge conducted in a dark and quiet room. The subject will be asked to remain awake while reacting to a visual stimulus, which appears for 1 second every 3 seconds, by hitting a button. Sleep latency will be defined as the delay between the onse | — |
Countries
France
Outcome results
None listed