Actively Recruiting
High Flow Nasal Oxygen For Hypercapnic, Acidotic Exacerbation Chronic Obstructive Pulmonary Disease
Led by Franciscus Gasthuis · Updated on 2025-08-21
40
Participants Needed
4
Research Sites
13 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
Researchers are investigating the use of High Flow Nasal Oxygen (HFNO) compared to the standard treatment Non-Invasive Ventilation (NIV) for patients experiencing acute acidotic hypercapnic exacerbations of Chronic Obstructive Pulmonary Disease (COPD). The study aims to assess the feasibility of a larger trial to determine if HFNO is not worse than NIV regarding the need for intubation and mortality, while potentially offering improved patient comfort and less nursing effort. This pilot study is prospective, randomized, and multi-center without blinding. Participants will receive either HFNO or NIV as their first line of treatment upon hospital presentation. For HFNO, patients start with a flow of 50 L/min, heated to 37°C, and oxygen levels adjusted to keep oxygen saturation between 88-92%. For NIV, patients will use either a facemask or helmet interface with specified pressure settings tailored for comfort and effective breathing support, also targeting oxygen saturation of 88-92%. All patients receive standard care including monitoring, blood tests, steroids, and inhaled bronchodilators. During the study, patients will be closely monitored for vital signs, respiratory parameters, comfort, and nursing effort from the start and at regular intervals until discharge. The main goal is to measure how feasible it is to conduct a larger randomized controlled trial, focusing on screening, inclusion rates, protocol adherence, and staff feedback. Additional follow-up includes questionnaires three months after admission to assess quality of life without requiring extra visits or blood samples beyond usual care. The total participation duration varies based on hospital stay and follow-up timing.
CONDITIONS
Brief Title
High Flow Nasal Oxygen for Exacerbation COPD
Who Can Participate
Eligibility Criteria
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 40 years or older
You will not qualify if you...
- Diagnosis of asthma
- Immediate need for intubation based on physician judgement
- Inability to apply either study intervention
- Patient unable to give informed consent (e.g., cognitive impairment, serious psychiatric disease)
- Established or indicated home NIV or CPAP use
- Imminent death
- Other respiratory diseases affecting treatment (e.g., acute heart attack, lung edema, large pulmonary embolism)
- Other acute illnesses preventing participation (e.g., unstable blood pressure, reduced consciousness)
- Tracheostomy
- Participation in other interventional trials
- Inability to admit to ICU or monitored ward
- Previous explicit objection to research participation
- Bicarbonate level below 20 mmol/L or less than 20 mmol/L if specified otherwise in full criteria (unclear)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 30 days
Participants receive respiratory support with either High Flow Nasal Oxygen (HFNO) or Non-Invasive Ventilation (NIV) as first line treatment for acidotic, hypercapnic COPD exacerbation. This includes admission to a monitored ward or ICU with intensive monitoring and regular assessments.
Multiple daily assessments during hospital stay until discharge
Duration - 3 months
Participants are followed up to assess quality of life, anxiety, depression, dyspnea, and other health outcomes after hospital discharge.
1 questionnaire visit at 3 months (remote or in-person)
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
Research Team
D
Dorien Kiers, MD, PhD
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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