REgistry-based Treatment Duration and Mortality in Long-term OXygen Therapy (REDOX) (REDOX)
Chronic Respiratory Failure With Hypoxia
About this trial
This is an interventional treatment trial for Chronic Respiratory Failure With Hypoxia focused on measuring COPD, Long-term oxygen therapy (LTOT), Registry, Registry-based randomized controlled trial (R-RCT), Treatment duration, Mortality
Eligibility Criteria
Inclusion Criteria:
- Age 18 years or older
- Severe resting hypoxemia (PaO2 < 7.4 kPa or oxygen saturation < 88% breathing air), or PaO2 < 8.0 kPa on air and either signs of heart failure or polycythemia (EVF > 0.54).
Exclusion Criteria:
- Smoking or contact with open fire
- Other inability to safely comply with LTOT
- Already on LTOT for more than 2 weeks
- Inability to comply with any of the study interventions as judged by the responsible oxygen staff
- Opt out from being registered in Swedevox
- Inability to give informed written consent to participate in the study as judged by the oxygen responsible staff
- Lack of Swedish identification number
- Previous participation in the study.
Patient populations that will be evaluated:
- Primary analysis: In all randomized patients according to the intention-to-treat and per protocol principles.
- Secondary analyses: In patients with 1) severe resting hypoxemia (PaO2 < 7.4 kPa breathing air); 2) moderate resting hypoxemia (PaO2 7.4 to 8.0 kPa breathing air); 3) COPD verified by spirometry (FEV1/FVC < 0.7 after bronchodilation); 4) and in patients with other conditions than COPD.
Sites / Locations
- Blekinge hospital
- Örebro University Hospital
Arms of the Study
Arm 1
Arm 2
Active Comparator
Active Comparator
LTOT 24 h/day (intervention)
LTOT 15 h/day (control)
Long-term oxygen therapy (LTOT) prescribed 24 h/day. The LTOT is provided according to standard clinical practice using oxygen concentrator, cylinders or liquid oxygen and administered mainly through nasal prongs. The oxygen dose (l/min) is titrated aiming at a PaO2 on oxygen > 8 kPa in accordance with current routine practice and management guidelines.
Long-term oxygen therapy (LTOT) prescribed 15 h/day. The LTOT is provided according to standard clinical practice using oxygen concentrator, cylinders or liquid oxygen and administered mainly through nasal prongs. The oxygen dose (l/min) is titrated aiming at a PaO2 on oxygen > 8 kPa in accordance with current routine practice and management guidelines.