RecruitingNot ApplicableNCT06084117
High Flow Nasal Oxygen for Exacerbation COPD
High Flow Nasal Oxygen For Hypercapnic, Acidotic Exacerbation Chronic Obstructive Pulmonary Disease
Sponsor
Franciscus Gasthuis
Enrollment
40 participants
Start Date
May 14, 2024
Study Type
INTERVENTIONAL
Conditions
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
Min Age: 40 Years
Inclusion Criteria3
- 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 Criteria12
- 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
Interventions
OTHERHFNO
Respiratory support with HFNO (as opposed to NIV, as per standard of care)
OTHERNIV
Respiratory support with Non-invasive ventilation, standard of care
Locations(4)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06084117
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