NCT06084117 High Flow Nasal Oxygen for Exacerbation COPD
| NCT ID | NCT06084117 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Franciscus Gasthuis |
| Condition | Acute Exacerbation of COPD |
| Study Type | INTERVENTIONAL |
| Enrollment | 40 participants |
| Start Date | 2024-05-14 |
| Primary Completion | 2026-09-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 40 participants in total. It began in 2024-05-14 with a primary completion date of 2026-09-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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
Eligibility 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
Contact & Investigator
Dorien Kiers, MD, PhD
PRINCIPAL INVESTIGATOR
Franciscus Gasthuis & Vlietland
Frequently Asked Questions
Who can join the NCT06084117 clinical trial?
This trial is open to participants of all sexes, aged 40 Years or older, studying Acute Exacerbation of COPD. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06084117 currently recruiting?
Yes, NCT06084117 is actively recruiting participants. Contact the research team at d.kiers@franciscus.nl for enrollment information.
Where is the NCT06084117 trial being conducted?
This trial is being conducted at Delft, Netherlands, Rotterdam, Netherlands, Rotterdam, Netherlands, The Hague, Netherlands.
Who is sponsoring the NCT06084117 clinical trial?
NCT06084117 is sponsored by Franciscus Gasthuis. The principal investigator is Dorien Kiers, MD, PhD at Franciscus Gasthuis & Vlietland. The trial plans to enroll 40 participants.
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