Effect of HIgh-flow Therapy in Long-term Oxygen Therapy

Sponsor
Skane University Hospital
Study ID
NCT06247397
Status
Recruiting
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Conditions

  • Chronic Obstructive Pulmonary Disease Severe
  • Chronic Respiratory Failure With Hypoxia
  • Interstitial Lung Disease

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Added high-flow oxygen therapy — DEVICE
    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 — OTHER
    Standard care with low-flow oxygen therapy in accordance with clinical routine.

Study Details

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 Dates

First listed
Feb 7, 2024
Start date
Jun 10, 2024
Status verified
May 2025
Primary completion
Dec 31, 2027
Completion
Dec 31, 2028

Study Design

Enrollment
310 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: High-flow oxygen therapy
    Intervention arm
  • Active Comparator: Low-flow oxygen therapy
    Comparison arm

Primary Outcome Measure

Time to first hospitalization or death from all causes [ Time Frame: 1 year ]

Central Contacts

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