NCT06084117Recruiting
High Flow Nasal Oxygen for Exacerbation COPD
High Flow Nasal Oxygen For Hypercapnic, Acidotic Exacerbation Chronic Obstructive Pulmonary Disease
Source: ClinicalTrials.gov · Last updated 21 Aug 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
In this pilot study the feasibility of performing a larger trial to study the non-inferiority of High Flow Nasal Oxygen compared to non-invasive ventilation in patients with acute acidotic hypercapnic exacerbation of COPD wil be investigated
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 40 (estimated)
- First submitted
- 2 Oct 2023
- Start date
- 14 May 2024
- Primary completion date
- 1 Sept 2026
- Lead sponsor
- Franciscus Gasthuis
- Diseases
- COPD
- NCT number
- NCT06084117
What you commit to
- Study type: Interventional
- Planned participants: 40
- From 14 May 2024 to the primary completion date, 1 Sept 2026
- 4 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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 illness
- 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).
- Other acute diseases that preclude participation in the trial such as hemodynamic instability (need for vasopressors), reduced consciousness with need for intubation, severe intoxication
Lab values
- Previous explicit (or written) objection to participation in research - bicarbonate \<20 mmol/L
Other
- Asthma
- Immediate need for intubation, based on clinical judgement of the attending physician.
- Impossibility to apply either one of the two interventions
- Impeding death
- 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).
Who the study is looking for
- 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
Age in the registry: 40 years to - · Sex: All · Does not accept healthy volunteers
Sites (4)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Reinier de Graaf Coordinator of this site? Confirm its status | Delft | Netherlands | Not yet recruiting |
| Ikazia Coordinator of this site? Confirm its status | Rotterdam | Netherlands | Not yet recruiting |
| Franciscus Gasthuis & Vlietland Coordinator of this site? Confirm its status | Rotterdam | Netherlands | Recruiting |
| Haaglanden Medisch Centrum Coordinator of this site? Confirm its status | The Hague | Netherlands | Not yet recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.