High Flow Nasal Oxygen for COPD Exacerbations

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This pilot study aims to assess the feasibility of conducting a larger trial to compare the effectiveness of High Flow Nasal Oxygen (HFNO) against non-invasive ventilation (NIV) in patients experiencing acute exacerbations of Chronic Obstructive Pulmonary Disease (COPD). The study focuses on patients with acidotic, hypercapnic conditions, where HFNO may provide a more tolerable and less resource-intensive alternative to NIV. The primary objective is to evaluate whether HFNO is non-inferior to NIV in terms of reducing the need for intubation and mortality, while also enhancing patient comfort and reducing nursing workload. The study will be prospective, randomized, multi-center, and unblinded.

Why it matters

Who can join: the full rules

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

Where it's running

• Franciscus Gasthuis & Vlietland
  Rotterdam, Netherlands Recruiting
• Reinier de Graaf
  Delft, Netherlands Not yet recruiting
• Ikazia
  Rotterdam, Netherlands Not yet recruiting
• Haaglanden Medisch Centrum
  The Hague, Netherlands Not yet recruiting

Study contacts

• Principal investigator: Dorien Kiers, MD, PhD — Franciscus Gasthuis & Vlietland
• Study coordinator: Dorien Kiers, MD, PhD
• Email: d.kiers@franciscus.nl
• Phone: +3110 461 6161

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.