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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-03-01

Study Completion Date

2027-02-28

Brief Summary

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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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Detailed Description

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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.

Conditions

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Interstitial Lung Disease Chronic Obstructive Pulmonary Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Continous oxygen

Oxygen delivery by Continous Oxygen Bottles

Group Type OTHER

Continous Oxygen by Bottles

Intervention Type DEVICE

Oxygen delivery by bottles giving a continous flow.

Demand Based Oxygen

Oxygen Delivery by Demand Oxygen delivery system.

Group Type OTHER

Demand oxygen by Portable Concentrator

Intervention Type DEVICE

Oxygen delivery by consentrators, giving oxygen only when inhaling.

Interventions

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Continous Oxygen by Bottles

Oxygen delivery by bottles giving a continous flow.

Intervention Type DEVICE

Demand oxygen by Portable Concentrator

Oxygen delivery by consentrators, giving oxygen only when inhaling.

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No