Actively Recruiting

Phase Not Applicable
Age: 40Years +
All Genders
NCT06084117

High Flow Nasal Oxygen for Exacerbation COPD

Led by Franciscus Gasthuis · Updated on 2025-08-21

40

Participants Needed

4

Research Sites

133 weeks

Total Duration

On this page

Sponsors

F

Franciscus Gasthuis

Lead Sponsor

R

Reinier de Graaf Groep

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

CONDITIONS

Official Title

High Flow Nasal Oxygen for Exacerbation COPD

Who Can Participate

Age: 40Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Known chronic obstructive pulmonary disease
  • Acute hypercapnic exacerbation with PaCO2 >45 mmHg or >6.0 kPa and pH 7.20-7.35
  • Age over 40 years
Not Eligible

You will not qualify if you...

  • Asthma
  • Immediate need for intubation based on physician judgment
  • Unable to use either HFNO or NIV
  • Unable to give informed consent due to cognitive impairment or psychiatric disease
  • Established or indicated home NIV or CPAP use
  • Expected death soon
  • Other respiratory or acute diseases affecting treatment efficacy (heart infarction, cardiogenic lung edema, massive pulmonary embolism)
  • Severe acute conditions (hemodynamic instability, reduced consciousness, severe intoxication)
  • Tracheostomy
  • Participation in other interventional trials
  • Unable to admit to ICU or monitored ward
  • Previous objection to research participation
  • Bicarbonate level below 20 mmol/L

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 4 locations

1

Reinier de Graaf

Delft, Netherlands

Not Yet Recruiting

2

Franciscus Gasthuis & Vlietland

Rotterdam, Netherlands

Actively Recruiting

3

Ikazia

Rotterdam, Netherlands

Not Yet Recruiting

4

Haaglanden Medisch Centrum

The Hague, Netherlands

Not Yet Recruiting

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Research Team

D

Dorien Kiers, MD, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

OTHER

Number of Arms

2

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