High Flow Nasal Oxygen for COPD Exacerbations
High Flow Nasal Oxygen For Hypercapnic, Acidotic Exacerbation Chronic Obstructive Pulmonary Disease
This study is testing if High Flow Nasal Oxygen can help people with COPD flare-ups just as well as non-invasive ventilation, while being easier to use and more comfortable.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 40 Years and up |
| Sex | All |
| Sponsor | Franciscus Gasthuis Academic / other |
| Locations | 4 sites (Delft and 3 other locations) |
| Trial ID | NCT06084117 on ClinicalTrials.gov |
What this trial studies
This pilot study aims to assess the feasibility of conducting a larger trial to compare the effectiveness of High Flow Nasal Oxygen (HFNO) against non-invasive ventilation (NIV) in patients experiencing acute exacerbations of Chronic Obstructive Pulmonary Disease (COPD). The study focuses on patients with acidotic, hypercapnic conditions, where HFNO may provide a more tolerable and less resource-intensive alternative to NIV. The primary objective is to evaluate whether HFNO is non-inferior to NIV in terms of reducing the need for intubation and mortality, while also enhancing patient comfort and reducing nursing workload. The study will be prospective, randomized, multi-center, and unblinded.
Who should consider this trial
Good fit: Ideal candidates for this study are patients over 40 years old with known COPD experiencing acute hypercapnic exacerbations.
Not a fit: Patients who are immediately in need of intubation or have conditions that preclude the use of either intervention will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a more effective and comfortable treatment option for patients with acute exacerbations of COPD.
How similar studies have performed: Previous studies have shown promising results for HFNO in non-hypercapnic respiratory failure, suggesting potential for success in this novel application.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Known chronic obstructive pulmonary disease * Acute hypercapnic exacerbation of this condition, defined as: PaCO2\>45 mmHg or \>6.0 kPa and pH 7.20-7.35 * Age \>40 years Exclusion Criteria: * Asthma * Immediate need for intubation, based on clinical judgement of the attending physician. * Impossibility to apply either one of the two interventions * Patient not expected to give immediate or delayed informed consent (e.g. known cognitive impairment, dementia, active serious psychiatric disease, mental retardation). * Established home-NIV or home CPAP, known indication for home-NIV or CPAP (e.g. OSAS or obesitas hypoventilation syndrome). * Impeding death * Concurrent (respiratory) diseases that may influence treatment efficacy: acute heart infarction, cardiogenic lung edema, massive pulmonary embolism (intermediate-high risk or more). NB; pulmonary infections (viral and bacterial) are a common cause of exacerbation and are no reason for exclusion. * Other acute diseases that preclude participation in the trial such as hemodynamic instability (need for vasopressors), reduced consciousness with need for intubation, severe intoxication * Tracheostomized patients * Participation in other interventional trials * Impossibility to admit the patient to the participating ICU or monitored ward (e.g. medium care / high dependency unit, depending on local infrastructure). * Previous explicit (or written) objection to participation in research - bicarbonate \<20 mmol/L
Where this trial is running
Delft and 3 other locations
- Reinier de Graaf — Delft, Netherlands (Not_yet_recruiting)
- Franciscus Gasthuis & Vlietland — Rotterdam, Netherlands (Recruiting)
- Ikazia — Rotterdam, Netherlands (Not_yet_recruiting)
- Haaglanden Medisch Centrum — The Hague, Netherlands (Not_yet_recruiting)
Study contacts
- Principal investigator: Dorien Kiers, MD, PhD — Franciscus Gasthuis & Vlietland
- Study coordinator: Dorien Kiers, MD, PhD
- Email: d.kiers@franciscus.nl
- Phone: +3110 461 6161
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.