RecruitingRecruiting
Effect of HIgh-flow Therapy in Long-term Oxygen Therapy
NCT06247397 · Skane University Hospital
In plain English
Click the button to translate this study into plain language — what it is, who qualifies, and what participation looks like.
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