NCT06767904Not yet recruiting
Continuous Versus Demand-Based Oxygen in Patients With Fibrotic Interstitial Lung Disease and Chronic Obstructive Pulmonary Disease
A Protocol for a Randomized Trial Comparing the Efficacy of Exertional Oxygen Delivery by Continuous Versus Demand-Based Flow Systems During Six-minute Walk Test in Patients With Fibrotic Interstitial Lung Disease and Chronic Obstructive Pulmonary Disease (OXYCODE)
Source: ClinicalTrials.gov · Last updated 17 Jan 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
The goal of this randomised clinical trial is to compare the efficacy of exertional oxygen delivery by continous versus demand-based flow systems in patients with fibrotic Interstitial lung disease and chronic obstructive pulmonary disease . The main questions it aim to answer: Is there a difference in lowest oxygen saturation? Is there a difference in saturation: time below \<90%, pulse rate, distance and patient preferences ? It is a cross over study, so all patients will test both methods. Participants will perform 2 6-minute walk tests with the two different oxygen delivery systems.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 60 (estimated)
- First submitted
- 5 Jan 2025
- Start date
- 1 Mar 2025
- Primary completion date
- 31 Aug 2026
- Lead sponsor
- Sissel Kronborg-White
- Diseases
- COPD
- NCT number
- NCT06767904
What you commit to
- Study type: Interventional
- Planned participants: 60
- From 1 Mar 2025 to the primary completion date, 31 Aug 2026
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Smoking during the previous 24 hours
Other illness
- Any physical condition including paralysis, lower extremity pain, or other musculoskeletal problems limiting exercise performance
- Unstable heart condition or symptomatic stenotic valve disease
Lab values
- Anemia, Hb \< 7.3 mmol/l (women) or \< 8.3 mmol/l (men)
Other
- Pregnant women
- Non-invasive ventilation
Who the study is looking for
- Age ≥ 18 years
- Verified diagnosis of fibrotic interstitial lung disease or chronic obstructive pulmonary disease
- Desaturation \< 88% during 6-minute walk test or currently receiving ambulatory oxygen by continous oxygen
- Able to walk at least 50 meters during a 6-minute walk test
- Self-reported stable respiratory symptoms in the previous 2 weeks
- Cognitively able to understand and participate in the study
- Written informed consent
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.