Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 7:58 PM
Ignite Modification Date:
2025-12-24 @ 7:58 PM
NCT ID:
NCT03441204
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 28 days
* 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) PaO2 (air) \< 7.4 kPa; 2) PaO2 (air) 7.4 to 8.0 kPa; 3) COPD verified by spirometry (COPD as primary diagnosis and FEV1/FVC \< 0.7 after bronchodilation); 4) and in patients with a primary diagnosis other than COPD.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03441204
Study Brief:
Protocol Section:
NCT03441204