ong-term high-flow nasal cannula therapy in patients with stable COPD: a prospective, randomized crossover study
- Conditions
- Chronic Obstructive Pulmonary Disease (COPD)
- Registration Number
- JPRN-UMIN000017639
- Lead Sponsor
- Kobe City Medical Center General Hospital Department of Respiratory Medicine
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 30
Not provided
1. Patients with severe kidney, liver or cardiovascular disease. 2. Patients with active malignant tumor. 3. Patients with acute disease. 4. Patients with any history of obstructive sleep apnea syndrome. 5. Patients with diseases affecting the efficacy endpoints who are regarded as inadequate for the study by the investigators. 6. Patients who have experienced a COPD exacerbation within the past 6 weeks prior to the informed consent. 7. Patients who have received nocturnal noninvasive positive pressure ventilation (NPPV), or had received it within 6 weeks prior to the informed consent. 8. Patients with history of tracheotomy, severe pharyngeal surgery or severe nasal cavity surgery within the last 6 months. 9. Patients who are pregnant. 10. Patients with cognitive impairment or mental disorder who are regarded as inadequate to evaluate for the study by the investigators. 11. Patients who are regarded as being unable to operate the myAIRVO2 inadequately at home by the investigators. 12. Patients who have participated in the other study at the time of the informed consent, or will participate in the other study. 13. Any other cases who are regarded as inadequate for the study enrollment by the investigators.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. Total St. George's respiratory questionnaire (SGRQ-C) score.
- Secondary Outcome Measures
Name Time Method 1. Quality-adjusted life year (QALY) by mapping the EQ-5D-5L utility scores 2. SGRQ-C: symptom score, activity score, impact score 3. Dyspnea intensity: the modified medical research council (mMRC) score 4. Arterial blood gas analysis (ABG): pH, PaO2, PaCO2 5. Oxygen Saturation (SpO2) 6. Nocturnal PtcCO2: median and 95th percentile 7. Pulmonary functions: VC, FVC, FEV1, FEV1/FVC, DLCO, RV, FRC, TLC 8. 6 minutes walk test (6MWT): 6- minute walk test distance, SpO2, modified borg scale (mBS) 9. Physical activity: calorie consumption, step-counts, activity time 10. Hospitalization for exacerbation 11. Medication change 12. Oxygen flow rate 13. Total flow rate 14. Adverse events