Clinical trial NCT06767904: Continuous Versus Demand-Based Oxygen in Patients With Fibrotic Interstitial Lung Disease and Chronic Obstructive Pulmonary Disease
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)
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Interstitial Lung Disease
Chronic Obstructive Pulmonary Disease
Keywords: Interstitial Lung Disease
Chronic Obstructive Pulmonary Disease
Oxygen Therapy
Palliation
Lead sponsor: University of Aarhus
Sponsor class: OTHER
First posted: 2025-01-10
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: 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.

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

Primary outcomes:
measure: Lowest oxygen
timeFrame: At Baseline
Secondary outcomes:
measure: percentage of saturation <90%
timeFrame: At baseline
measure: minutes of saturation <90%
timeFrame: At baseline
measure: minimum value of oxygen
timeFrame: At baseline
measure: Pulse rate
timeFrame: At baseline
measure: Maximum pulse rate
timeFrame: At baseline
measure: Distance
timeFrame: At baseline
measure: time to recover
timeFrame: At baseline
measure: Maximal Borg scale
timeFrame: At baseline
measure: Change Borg scale
timeFrame: At baseline
measure: Patient preference
timeFrame: At baseline
measure: Comfort Likert scale
timeFrame: At baseline
measure: Reliability Likert scale
timeFrame: At baseline
measure: Semi structured qualitative interviews
timeFrame: After 3-6 months
measure: comfort and frequency use oxygen
timeFrame: After 3-6 months
measure: Quality of life questionnaire score
timeFrame: After 3-6 months
measure: Baseline Characteristics
timeFrame: After 3-6 months
Other outcomes:
Locations:
Study officials:
affiliation: Aarhus University Hospital
name: Sissel Kronborg-White, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: