Trials / Recruiting
RecruitingNCT06247397
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
- Status
- Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 310 (estimated)
- Sponsor
- Skane University Hospital · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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).
Detailed description
This is a registry-based, randomized, controlled clinical trial of patients with LTOT for COPD or ILD recruited using the Swedish National Registry for Respiratory Failure (Swedevox) in collaboration with a research network within the Swedish Respiratory Society. The trial evaluates the effect of added high-flow oxygen therapy nighttime to the regular low-flow oxygen therapy compared with regular low-flow oxygen therapy alone up to one year. The purpose of this project is to improve evidence-based treatment of people with chronic respiratory failure, currently about 2000 patients annually in Sweden, who have high risk of adverse events and mortality.
Conditions
- Chronic Obstructive Pulmonary Disease Severe
- Interstitial Lung Disease
- Chronic Respiratory Failure With Hypoxia
Interventions
| Type | Name | Description |
|---|---|---|
| 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. |
Timeline
- Start date
- 2024-06-10
- Primary completion
- 2027-12-01
- Completion
- 2028-12-01
- First posted
- 2024-02-07
- Last updated
- 2025-05-21
Locations
2 sites across 1 country: Sweden
Source: ClinicalTrials.gov record NCT06247397. Inclusion in this directory is not an endorsement.