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NCT Number: NCT06767904

Continuous Versus Demand-Based Oxygen in Patients With Fibrotic Interstitial Lung Disease and Chronic Obstructive Pulmonary Disease

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Continous Oxygen by Bottles

Device

Oxygen delivery by bottles giving a continous flow.

Demand oxygen by Portable Concentrator

Device

Oxygen delivery by consentrators, giving oxygen only when inhaling.

Primary outcomes

  1. Lowest oxygen

    Time frame: At Baseline

    difference in the lowest oxygen saturation between the two different oxygen delivery systems during a 6-min. walk test.

Secondary outcomes

  1. percentage of saturation <90%

    Time frame: At baseline

    Percentage of time when oxygen levels fall below 90% during walk test.

  2. minutes of saturation <90%

    Time frame: At baseline

    Number of minutes when saturation falls below 90% during walk test.

  3. minimum value of oxygen

    Time frame: At baseline

    Minimum value of oxygen saturation during walk test

  4. Pulse rate

    Time frame: At baseline

    Mean pulse rate during walk test

  5. Maximum pulse rate

    Time frame: At baseline

    Maximum pulse rate during walk test

  6. Distance

    Time frame: At baseline

    Difference in walk test distance

  7. time to recover

    Time frame: At baseline

    The time taken to recover oxygen saturation after walk test to the level obtained at rest

  8. Maximal Borg scale

    Time frame: At baseline

    Maximal rating of dyspnea on the Borg scale (Borg Rating of Percived exertion, range 0-10, where 10 is maximal breathing difficulty).

  9. Change Borg scale

    Time frame: At baseline

    Change in dyspnea from rest to end of the walk test measured by the Borg scale. (Borg Rating of Percived exertion, range 0-10, where 10 is maximal breathing difficulty)

  10. Patient preference

    Time frame: At baseline

    Patient preferences for the two different systems ("Which system do you prefer?"

  11. Comfort Likert scale

    Time frame: At baseline

    Comfort measured by a Likert scale on a scale from 1-7 where 1 equals strongly disagree and 7 equals strongly agree. There is no unabbreviated scale title.

  12. Reliability Likert scale

    Time frame: At baseline

    Reliability measured by a Likert scale on a scale from 1-7 where 1 equals strongly disagree and 7 equals strongly agree. There is no unabbreviated scale title.

  13. Semi structured qualitative interviews

    Time frame: After 3-6 months

    Semi-structured qualitative interviews about patients' view on the different oxygen delivery systems

  14. comfort and frequency use oxygen

    Time frame: After 3-6 months

    Questions regarding the use of the oxygen delivery systems with respect to comfort and frequency of use

  15. Quality of life questionnaire score

    Time frame: After 3-6 months

    Change on Quality of life questionnaires between baseline and three to six months

  16. Baseline Characteristics

    Time frame: After 3-6 months

    Associations between baseline characteristics and effect of and patient views on oxygen delivery systems

Study contacts

Contact information is provided by the study sponsor or research team.

Sissel Kronborg-White, MD, PhD

CONTACT

[email protected]

004524978716

Sponsors and collaborators

Lead sponsor

Sissel Kronborg-White

Other

Registry information

Official study 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)

Acronym: OXYODE

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
Jan 10, 2025
Registry last updated
Jan 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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