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NCT06084117Recruiting

High Flow Nasal Oxygen for Exacerbation COPD

High Flow Nasal Oxygen For Hypercapnic, Acidotic Exacerbation Chronic Obstructive Pulmonary Disease

Source: ClinicalTrials.gov · Last updated 21 Aug 2025 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

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

Status (registry)
Recruiting
Study type
Interventional
Enrollment
40 (estimated)
First submitted
2 Oct 2023
Start date
14 May 2024
Primary completion date
1 Sept 2026
Lead sponsor
Franciscus Gasthuis
Diseases
COPD
NCT number
NCT06084117

What you commit to

  • Study type: Interventional
  • Planned participants: 40
  • From 14 May 2024 to the primary completion date, 1 Sept 2026
  • 4 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • 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 illness

  • 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).
  • Other acute diseases that preclude participation in the trial such as hemodynamic instability (need for vasopressors), reduced consciousness with need for intubation, severe intoxication

Lab values

  • Previous explicit (or written) objection to participation in research - bicarbonate \<20 mmol/L

Other

  • Asthma
  • Immediate need for intubation, based on clinical judgement of the attending physician.
  • Impossibility to apply either one of the two interventions
  • Impeding death
  • 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).

Who the study is looking for

  • 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

Age in the registry: 40 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (4)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Reinier de Graaf
Coordinator of this site? Confirm its status
DelftNetherlandsNot yet recruiting
Ikazia
Coordinator of this site? Confirm its status
RotterdamNetherlandsNot yet recruiting
Franciscus Gasthuis & Vlietland
Coordinator of this site? Confirm its status
RotterdamNetherlandsRecruiting
Haaglanden Medisch Centrum
Coordinator of this site? Confirm its status
The HagueNetherlandsNot yet recruiting

This page is information, not medical advice. Discuss any trial with your doctor.