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

N/ANot Yet RecruitingNCT06767904

Sissel Kronborg-White60 enrolled

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Interventions

Continous Oxygen by BottlesDEVICE

Oxygen delivery by bottles giving a continous flow.

Demand oxygen by Portable ConcentratorDEVICE

Oxygen delivery by consentrators, giving oxygen only when inhaling.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Lowest oxygen

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

Time frame: At Baseline

Secondary Outcomes

percentage of saturation <90%

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

Time frame: At baseline

minutes of saturation <90%

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

Time frame: At baseline

minimum value of oxygen

Minimum value of oxygen saturation during walk test

Time frame: At baseline

Pulse rate

Mean pulse rate during walk test

Time frame: At baseline

Maximum pulse rate

Maximum pulse rate during walk test

Time frame: At baseline

Distance

Difference in walk test distance

Time frame: At baseline

time to recover

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

Time frame: At baseline

Maximal Borg scale

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 Borg scale

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 preference

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

Time frame: At baseline

Comfort Likert scale

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 Likert scale

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: At baseline

Semi structured qualitative interviews

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

Time frame: After 3-6 months

comfort and frequency use oxygen

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

Time frame: After 3-6 months

Quality of life questionnaire score

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

Time frame: After 3-6 months

Baseline Characteristics

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

Time frame: After 3-6 months

Central Contacts

Sissel Kronborg-White, MD, PhD

CONTACT

004524978716 siskro@rm.dk

Data from ClinicalTrials.gov

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