Effect of HIgh-flow Therapy in Long-term Oxygen Therapy
Recruiting now · Not applicable
Conditions studied: Chronic Obstructive Pulmonary Disease Severe, Interstitial Lung Disease, Chronic Respiratory Failure With Hypoxia
In brief
This is a registry-based, randomized, controlled clinical trial of the effect of added high-flow oxygen therapy (using the device Lumis HFT) during one year in people with long-term oxygen therapy (LTOT) for chronic obstructive pulmonary disease (COPD) or interstitial lung disease (ILD).
Key facts
- Study ID
- NCT06247397
- Run by
- Skane University Hospital
- People needed
- 310
- Starts
- 2024-06-10
- Expected to finish
- 2028-12-01
- Last updated by the study team
- 2025-05-21
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Age 40 years or older
- Ongoing LTOT: prescribed for at least 15 hours per day; and since at least 28 days as registered in Swedevox
- COPD or ILD as main underlying reason for LTOT
- Oxygen concentrator as stationary oxygen source in the home including night-time
- Body mass index (BMI) < 35 kg/m2
You may not qualify if…
- Current or previous treatment with home HFOT
- Current treatment with home mechanical ventilation
- Current treatment with home CPAP
- Hospitalized during the last 2 weeks
- Current smoking or contact with flames
- Self-reported average use of the LTOT < 15h per day (24 hours)
- PaCO2 (breathing air at rest) > 8 kPa
- Strong clinical suspicion of obstructive sleep apnea (OSA) or obesity-related hypoventilation syndrome (OHS) (as judged by the responsible staff)
- Inability to participate in the study procedures (as judged by the staff)
- Not eligible for continuing LTOT due to other reason (as judged by the staff)
- Expected survival less than 3 months (as judged by the staff)
Where it is running
- Research Unit, Blekinge University of Technology — Karlskrona, Blekinge County, Sweden (enrolling)
- Department of Heart, Lung and Clinical Physiology, Örebro University Hospital — Örebro, Sweden (enrolling)
Full record on ClinicalTrials.gov
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