RECRUITINGINTERVENTIONAL
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
About This Trial
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).
Who May Be Eligible (Plain English)
Who May Qualify:
- 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
Who Should NOT Join This Trial:
- 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)
Always talk to your doctor about whether this trial is right for you.
Original Eligibility Criteria
View original clinical language
Inclusion Criteria:
* 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 Criteria:
* 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)
Treatments Being Tested
DEVICE
Added high-flow oxygen therapy
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.
OTHER
Standard care
Standard care with low-flow oxygen therapy in accordance with clinical routine.
Locations (2)
Research Unit, Blekinge University of Technology
Karlskrona, Blekinge County, Sweden
Department of Heart, Lung and Clinical Physiology, Örebro University Hospital
Örebro, Sweden