High Flow Nasal Oxygen for Exacerbation COPD
Recruiting now · Not applicable
Conditions studied: Acute Exacerbation of COPD
In brief
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
Key facts
- Study ID
- NCT06084117
- Run by
- Franciscus Gasthuis
- People needed
- 40
- Starts
- 2024-05-14
- Expected to finish
- 2026-12-01
- Last updated by the study team
- 2025-08-21
Who can join
Age: 40 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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 it is running
- Franciscus Gasthuis & Vlietland — Rotterdam, Netherlands (enrolling)
- Reinier de Graaf — Delft, Netherlands
- Ikazia — Rotterdam, Netherlands
- Haaglanden Medisch Centrum — The Hague, Netherlands
Full record on ClinicalTrials.gov
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