Status:
RECRUITING
High Flow Nasal Oxygen for Exacerbation COPD
Lead Sponsor:
Franciscus Gasthuis
Collaborating Sponsors:
Reinier de Graaf Groep
Haga Medisch Centrum
Conditions:
Acute Exacerbation of COPD
Eligibility:
All Genders
40+ years
Phase:
NA
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...
Detailed Description
Rationale: Chronic Obstructive Pulmonary Disease (COPD) is frequently complicated by a worsening of symptoms, known as acute exacerbations (AECOPD). These exacerbations can result in a life-threatenin...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 14 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2026
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT06084117
Start Date
May 14 2024
End Date
December 1 2026
Last Update
August 21 2025
Active Locations (4)
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1
Reinier de Graaf
Delft, Netherlands
2
Franciscus Gasthuis & Vlietland
Rotterdam, Netherlands
3
Ikazia
Rotterdam, Netherlands
4
Haaglanden Medisch Centrum
The Hague, Netherlands