Effect of HIgh-flow Therapy in Long-term Oxygen Therapy
Effect of HIgh-flow Therapy in Long-term Oxygen Therapy (HILOT): A Multicenter, Registry-based, Randomized Clinical Trial
Skane University Hospital
310 participants
Jun 10, 2024
INTERVENTIONAL
Conditions
Summary
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).
Eligibility
Inclusion Criteria5
- 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
Exclusion Criteria11
- 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)
Interventions
Added high-flow oxygen therapy using the device Lumis HFT during nighttime and at the patient's discretion daytime, with the usual care (low-flow oxygen therapy) the rest of the time.
Standard care with low-flow oxygen therapy in accordance with clinical routine.
Locations(2)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06247397