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

NCT06247397 · Skane University Hospital
In plain English

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Official title
Effect of HIgh-flow Therapy in Long-term Oxygen Therapy (HILOT): A Multicenter, Registry-based, Randomized Clinical Trial
About this study
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.
Eligibility criteria
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)
Study design
Enrollment target: 310 participants
Allocation: randomized
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2024-06-10
Estimated completion: 2028-12
Last updated: 2025-05-21
Interventions
Device: Added high-flow oxygen therapyOther: Standard care
Primary outcomes
  • Time to first hospitalization or death from all causes (1 year)
Sponsor
Skane University Hospital · other
With: Uppsala University Hospital, Region Stockholm, Region Örebro County, Blekinge County Council Hospital, Blekinge Institute of Technology, Lund University, Region Östergötland, Vastra Gotaland Region, Region Västerbotten, Landstinget i Värmland, ResMed, Swedish Heart Lung Foundation, The Swedish Research Council
Contacts & investigators
ContactMagnus Ekström, MD, PhD · contact · magnus.ekstrom@med.lu.se · 0455731000
InvestigatorMagnus Ekström, MD, PhD · principal_investigator, Skane University Hospital
All locations (2)
Research Unit, Blekinge University of TechnologyRecruiting
Karlskrona, Blekinge County, Sweden
Department of Heart, Lung and Clinical Physiology, Örebro University HospitalRecruiting
Örebro, Sweden
Effect of HIgh-flow Therapy in Long-term Oxygen Therapy · TrialPath