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

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)

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Chronic Obstructive Pulmonary Disease; Interstitial Lung Disease
• Intervention / Treatment: Device: Continous Oxygen by Bottles; Device: Demand oxygen by Portable Concentrator

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 Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Sissel Kronborg-White, MD, PhD; Phone Number: 004524978716; Email: siskro@rm.dk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Continous oxygen; Oxygen delivery by Continous Oxygen Bottles	Device: Continous Oxygen by Bottles; Oxygen delivery by bottles giving a continous flow.
Other: Demand Based Oxygen; Oxygen Delivery by Demand Oxygen delivery system.	Device: Demand oxygen by Portable Concentrator; Oxygen delivery by consentrators, giving oxygen only when inhaling.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Lowest oxygen	difference in the lowest oxygen saturation between the two different oxygen delivery systems during a 6-min. walk test.	At Baseline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
percentage of saturation <90%	Percentage of time when oxygen levels fall below 90% during walk test.	At baseline
minutes of saturation <90%	Number of minutes when saturation falls below 90% during walk test.	At baseline
minimum value of oxygen	Minimum value of oxygen saturation during walk test	At baseline
Pulse rate	Mean pulse rate during walk test	At baseline
Maximum pulse rate	Maximum pulse rate during walk test	At baseline
Distance	Difference in walk test distance	At baseline
time to recover	The time taken to recover oxygen saturation after walk test to the level obtained at rest	At baseline
Patient preference	Patient preferences for the two different systems ("Which system do you prefer?"	At baseline
Semi structured qualitative interviews	Semi-structured qualitative interviews about patients' view on the different oxygen delivery systems	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	After 3-6 months
Quality of life questionnaire score	Change on Quality of life questionnaires between baseline and three to six months	After 3-6 months
Baseline Characteristics	Associations between baseline characteristics and effect of and patient views on oxygen delivery systems	After 3-6 months
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).	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)	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.	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.	At baseline

Collaborators and Investigators

• Sponsor: Sissel Kronborg-White
• Investigators: Principal Investigator: Sissel Kronborg-White, MD, PhD, Aarhus University Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): March 1, 2025
• Primary Completion (Estimated): August 31, 2026
• Study Completion (Estimated): February 28, 2027

Study Registration Dates

• First Submitted: January 5, 2025
• First Submitted That Met QC Criteria: January 5, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 15, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Keywords: Chronic Obstructive Pulmonary Disease; Interstitial Lung Disease; Palliation; Oxygen Therapy
• Additional Relevant MeSH Terms: Pathologic Processes; Chronic Disease; Disease Attributes; Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive; Lung Diseases, Interstitial
• Other Study ID Numbers: OXYCODE

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Full access to the protocol, participants dataset and statistical codes will be granted on reasonable request.
• IPD Sharing Time Frame: Full access to the protocol, participants dataset and statistical codes will be granted on reasonable request for up to 5 years after the study has ended.
• IPD Sharing Access Criteria: Full access to the protocol, participants dataset and statistical codes will be granted on reasonable request.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No