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

NCT06767904 | Not Yet Recruiting

• 1 other identifier: OXYCODE
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Interstitial Lung Disease; Chronic Obstructive Pulmonary Disease

Keywords

Interstitial Lung Disease; Chronic Obstructive Pulmonary Disease; Oxygen Therapy; Palliation

Outcome Measures

Primary Outcomes (1)

• Lowest oxygen

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

  At Baseline

Secondary Outcomes (16)

• percentage of saturation <90%

  At baseline

• minutes of saturation <90%

  At baseline

• minimum value of oxygen

  At baseline

• Pulse rate

  At baseline

• Maximum pulse rate

  At baseline

Study Arms (2)

Continous oxygen

OTHER

Oxygen delivery by Continous Oxygen Bottles

Device: Continous Oxygen by Bottles

Demand Based Oxygen

OTHER

Oxygen Delivery by Demand Oxygen delivery system.

Device: Demand oxygen by Portable Concentrator

Interventions

Continous Oxygen by Bottles DEVICE

Oxygen delivery by bottles giving a continous flow.

Continous oxygen

Demand oxygen by Portable Concentrator DEVICE

Oxygen delivery by consentrators, giving oxygen only when inhaling.

Demand Based Oxygen

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sissel Kronborg-White: lead

Related Publications (1)

• Kronborg-White S, Jensen JH, Bendstrup E, Prior TS. Comparing the efficacy of exertional oxygen delivery by continuous versus demand-based flow systems during 6-minute walk test in patients with fibrotic interstitial lung disease and COPD in a hospital setting (OXYCODE): a protocol for a randomised trial. BMJ Open. 2025 May 16;15(5):e099664. doi: 10.1136/bmjopen-2025-099664.

  PMID: 40379312 DERIVED

MeSH Terms

Conditions

Lung Diseases, Interstitial; Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Sissel Kronborg-White, MD, PhD

  Aarhus University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sissel Kronborg-White, MD, PhD

CONTACT

004524978716; siskro@rm.dk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Pulmonologist

Study Record Dates

• First Submitted: January 5, 2025
• First Posted: January 10, 2025
• Study Start: March 1, 2025
• Primary Completion (Estimated): August 31, 2026
• Study Completion (Estimated): February 28, 2027
• Last Updated: January 17, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• 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.
• Access Criteria: Full access to the protocol, participants dataset and statistical codes will be granted on reasonable request.