Continuous Versus Demand-Based Oxygen in Patients With Fibrotic Interstitial Lung Disease and Chronic Obstructive Pulmonary Disease
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Continous Oxygen by Bottles, Demand oxygen by Portable Concentrator.
- Who it may be relevant to
- Registry conditions: Interstitial Lung Disease, Chronic Obstructive Pulmonary Disease. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
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)
Overview
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.
Detailed description
The study design is a single center, randomized, open-label cross-over exploratory comparative study to investigate the efficacy of two different oxygen delivery systems. Patients with chronic obstructive Pulmonary disease or fibrotic Interstitial Lung Disease that during a six-minute walk test can walk at least 50 m and desaturate below 88%, can be included in the study. The participants are performing 2 6-minute walk tests, randomized to perform the test with oxygen bottles or portable concentrators first. Primary endpoint is the difference in the lowest oxygen saturation between the two systems. Secondary endpoints are amongst others: difference in percentage of time and number of minutes when oxygen falls below 90%, mean and maximum pulse rate, distance and time taken to recover during the 6-minute walk test and scores from questionnaires. After 3-6 months, semistructured interviews will be done to record participants' experiences of ambulatory oxygen therapy.
Interventions
- Device Continous Oxygen by Bottles
Oxygen delivery by bottles giving a continous flow. - Device Demand oxygen by Portable Concentrator
Oxygen delivery by consentrators, giving oxygen only when inhaling.
Primary outcome measures
- Lowest oxygen [Time frame: At Baseline]
Secondary outcome measures (12)
- percentage of saturation <90% [Time frame: At baseline]
- minutes of saturation <90% [Time frame: At baseline]
- minimum value of oxygen [Time frame: At baseline]
- Pulse rate [Time frame: At baseline]
- Maximum pulse rate [Time frame: At baseline]
- Distance [Time frame: At baseline]
- time to recover [Time frame: At baseline]
- Maximal Borg scale [Time frame: At baseline]
- Change Borg scale [Time frame: At baseline]
- Patient preference [Time frame: At baseline]
- Comfort Likert scale [Time frame: At baseline]
- Reliability Likert scale [Time frame: At baseline]
Eligibility criteria
Inclusion criteria
- 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
Exclusion criteria
- Any physical condition including paralysis, lower extremity pain, or other musculoskeletal problems limiting exercise performance
- Unstable heart condition or symptomatic stenotic valve disease
- Smoking during the previous 24 hours
- Pregnant women
- Anemia, Hb < 7.3 mmol/l (women) or < 8.3 mmol/l (men)
- Non-invasive ventilation
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Crossover
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Publications
- Kronborg-White S, Jensen JH, Bendstrup E, Prior TS. Comparing the efficacy of exertional oxygen delivery by continuous versus demand-based flow systems during 6-minute walk test in patients with fibrotic interstitial lung disease and COPD in a hospital setting (OXYCODE): a protocol for a randomised trial. BMJ Open. 2025 May 16;15(5):e099664. doi: 10.1136/bmjopen-2025-099664. PMID 40379312
Identifiers
NCT: NCT06767904 · OXYCODE