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

Not Applicable

Not yet recruiting

• Conditions: Interstitial Lung Disease; Chronic Obstructive Pulmonary Disease

• Registration Number: NCT06767904
• Lead Sponsor: Sissel Kronborg-White

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.

Study Timeline

• Status Verified: 2025-01
• Study First Submitted: 2025-01-05
• Study First Submitted QC: 2025-01-05
• Study First Posted: 2025-01-10
• Last Update Submitted: 2025-01-15
• Last Update Posted: 2025-01-17
• Study Start: 2025-03-01
• Primary Completion: 2026-08-31
• Study Completion: 2027-02-28

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
Lowest oxygen	At Baseline	difference in the lowest oxygen saturation between the two different oxygen delivery systems during a 6-min. walk test.

Secondary Outcome Measures

Name	Time	Method
Maximum pulse rate	At baseline	Maximum pulse rate during walk test
Distance	At baseline	Difference in walk test distance
time to recover	At baseline	The time taken to recover oxygen saturation after walk test to the level obtained at rest
percentage of saturation <90%	At baseline	Percentage of time when oxygen levels fall below 90% during walk test.
minutes of saturation <90%	At baseline	Number of minutes when saturation falls below 90% during walk test.
Pulse rate	At baseline	Mean pulse rate during walk test
minimum value of oxygen	At baseline	Minimum value of oxygen saturation during walk test
Maximal Borg scale	At baseline	Maximal rating of dyspnea on the Borg scale (Borg Rating of Percived exertion, range 0-10, where 10 is maximal breathing difficulty).
Change Borg scale	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)
Comfort Likert scale	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.
comfort and frequency use oxygen	After 3-6 months	Questions regarding the use of the oxygen delivery systems with respect to comfort and frequency of use
Patient preference	At baseline	Patient preferences for the two different systems ("Which system do you prefer?"
Quality of life questionnaire score	After 3-6 months	Change on Quality of life questionnaires between baseline and three to six months
Reliability Likert scale	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.
Semi structured qualitative interviews	After 3-6 months	Semi-structured qualitative interviews about patients' view on the different oxygen delivery systems
Baseline Characteristics	After 3-6 months	Associations between baseline characteristics and effect of and patient views on oxygen delivery systems