Comparing High-Flow Nasal Oxygen Therapy to Noninvasive Ventilation for COPD Exacerbations
High-Flow Nasal Oxygen Therapy for Exacerbation of Chronic Pulmonary Obstructive Disease: A Randomized, Open-label, Single-center, Pilot Study.
This study is testing whether High-Flow Nasal Oxygen therapy can work better than Noninvasive Ventilation for people with COPD who are having a moderate flare-up.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 44 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Centre Hospitalier Régional d'Orléans Academic / other |
| Locations | 1 site (Orléans) |
| Trial ID | NCT03488628 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the effectiveness of High-Flow Nasal Oxygen (HFNO) therapy compared to Noninvasive Ventilation (NIV) in patients experiencing a moderate exacerbation of Chronic Obstructive Pulmonary Disease (COPD). Eligible patients will be randomly assigned to receive either HFNO or NIV upon admission to the intensive care unit, with both groups monitored for arterial blood gas variables over the first 24 hours. The primary objectives include assessing the efficacy based on arterial pH levels and safety through the ratio of arterial partial pressure of oxygen to inspired oxygen fraction. This research seeks to determine if HFNO can be a viable alternative to the standard NIV treatment.
Who should consider this trial
Good fit: Ideal candidates for this study are adults over 18 years old with a known diagnosis of COPD experiencing a moderate exacerbation.
Not a fit: Patients under 18, pregnant individuals, or those with contraindications to either HFNO or NIV will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a less invasive and more effective treatment option for patients with acute exacerbations of COPD.
How similar studies have performed: While HFNO has been used in various respiratory conditions, this specific comparison with Noninvasive Ventilation for COPD exacerbations is novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age \> 18 * Known Chronic Obstructive Pulmonary disease (COPD) * respiratory rate or presence of accessory respiratory muscles activity on physical exam * moderate exacerbation of COPD as defined by an arteria pH between 7.25 and 7.35 and an arterial carbon dioxide partial pressure (PaCO2) equal or above 45 mm Hg Exclusion Criteria: * Age below 18 * Pregnancy * Known sleep apnea syndrome * Patent treated by noninvasive ventilation at home * Not affiliated to French scial security * Contraindication to aither Noninvasive ventilation or to High-Flow Nasal Oxygen therapy * Previous inclusion in the study
Where this trial is running
Orléans
- CHR d'Orléans — Orléans, France (Recruiting)
Study contacts
- Principal investigator: Mai-Anh Nay, MD — Centre Hospitalier Régional d'Orléans
- Study coordinator: Aurélie Despujols
- Email: aurelie.despujols@chr-orleans.fr
- Phone: 33 2 38 74 40 71
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.