Continous Oxygen by Bottles
DeviceOxygen delivery by bottles giving a continous flow.
NCT Number: NCT06767904
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.
Trial opening soon.
Get Notified18 year and older
All sexes
Interventional
Not applicable
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Oxygen delivery by bottles giving a continous flow.
Oxygen delivery by consentrators, giving oxygen only when inhaling.
Time frame: At Baseline
difference in the lowest oxygen saturation between the two different oxygen delivery systems during a 6-min. walk test.
Time frame: At baseline
Percentage of time when oxygen levels fall below 90% during walk test.
Time frame: At baseline
Number of minutes when saturation falls below 90% during walk test.
Time frame: At baseline
Minimum value of oxygen saturation during walk test
Time frame: At baseline
Mean pulse rate during walk test
Time frame: At baseline
Maximum pulse rate during walk test
Time frame: At baseline
Difference in walk test distance
Time frame: At baseline
The time taken to recover oxygen saturation after walk test to the level obtained at rest
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).
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)
Time frame: At baseline
Patient preferences for the two different systems ("Which system do you prefer?"
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.
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.
Time frame: After 3-6 months
Semi-structured qualitative interviews about patients' view on the different oxygen delivery systems
Time frame: After 3-6 months
Questions regarding the use of the oxygen delivery systems with respect to comfort and frequency of use
Time frame: After 3-6 months
Change on Quality of life questionnaires between baseline and three to six months
Time frame: After 3-6 months
Associations between baseline characteristics and effect of and patient views on oxygen delivery systems
Contact information is provided by the study sponsor or research team.
Sissel Kronborg-White
Other
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
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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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