REgistry-based Treatment Duration and Mortality in Long-term OXygen Therapy (REDOX)

• Status: Recruiting
• Trial end date: 2023-12-31
• Target enrollment: 0
• Participant gender: All

Summary

Multicenter, phase IV, registry-based, randomized controlled trial. Patients starting long-term oxygen therapy (LTOT) are randomized between LTOT prescribed 24 h/day or 15 h/day using the Swedish Register for Respiratory Failure (Swedevox). Clinical follow-up and concurrent treatments are according to routine clinical practice. The main endpoints of mortality, hospitalizations, and incident disease are assessed using Swedish registry data, with expected complete follow-up. Patient-reported outcomes are assessed using a posted questionnaire at 3 and 12 months. The study is managed by the Uppsala Clinical Research Centre (UCR).

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Skane University Hospital
• Collaborators: Blekinge County Council Hospital; Lund University

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.