Automated Oxygen Titration During Walking in Patients With Lung Fibrosis (OXYWILD)

NCT06465654 | Completed

• 1 other identifier: UAarhus_OXYWILD
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 1

Brief Summary

Fibrotic lung disease is a group of severe scarring lung diseases with a dismal prognosis, often leading to respiratory failure and need for oxygen treatment. The symptom burden is often extremely high with dyspnea at rest and increasing dyspnea with exertion. Patients will often need more oxygen during activity thus repeatedly adjustments of oxygen flow rates are required to target an acceptable saturation at rest and during activities. This is impractical and can lead to an undesirable focus on oxygen levels as well as reduced use of the oxygen treatment in everyday life. There is an urgent need for oxygen equipment that is easy to use to help patients live a life with fever symptom-related restrictions. Closed Loop Oxygen Titration (CLOT) is a new type of optimized oxygen treatment, which automatically adjusts the oxygen flow rate to the exact amount needed for the patient. The CLOT has already been tested and found useful in patients with other lung diseases, however it has not yet been tested in an isolated group of patients with fibrotic lung disease. The goal of this clinical trial is therefore to study if automatically adjusted oxygen delivery can be useful for patients with fibrotic lung disease who needs oxygen treatment during activity. The main questions aimed to be answered are: Will participants experience less breathlessness during walking, when the oxygen supply is individually adjusted to maintain an acceptable level of oxygen saturation? Our hypotheses are that automatically adjusted oxygen dose during walking will results in less breathlessness compared to the usual fixed dose of oxygen. Furthermore, that participants will walk longer and maintain a better oxygen saturation during a walking test when offered automatically adjusted oxygen dose. Participants will perform two walking tests with both automatically adjusted and fixed dose oxygen in random order, and the difference in sensation of breathlessness will be compared between the two tests.

Conditions

Fibrosis Lung; Respiratory Therapy

Keywords

Automated oxygen titration; Fibrotic interstitial lung disease; Walking test

Outcome Measures

Primary Outcomes (1)

• Borg dyspnea score

  Primary outcome is the difference in Borg dyspnea score at isotime between the two endurance shuttle walk test (fixed dose oxygen compared to automated variable dose oxygen). The dyspnea score is rated every minute with the Borg Category-Ratio (CR)10 scale, where 0 is "no dyspnea at all" and 10 is "maximum dyspnea ever experienced".

  At baseline and through completion (one day)

Secondary Outcomes (6)

• Walking distance

  At baseline and through completion (one day)

• Walking time

  At baseline and through completion (one day)

• Oxygen flow rate

  At baseline and through completion (one day)

• Oxygen saturation levels

  At baseline and through completion (one day)

• Hypoxemia

  At baseline and through completion (one day)

Study Arms (2)

Endurance shuttle walk test with fixed dose oxygen treatment

ACTIVE COMPARATOR

The participant will conduct an endurance shuttle walk test with a fixed oxygen dose of 4 liters/minute delivered by the O2matic.

Other: Fixed dose oxygen treatment

Endurance shuttle walk test with automated variable dose oxygen treatment

EXPERIMENTAL

The participant will conduct an endurance shuttle walk test with closed loop oxygen titration using O2matic to deliver a variable oxygen dosage set at an oxygen saturation target of 90 to 94 percent and an oxygen flow of 4 - 15 liters/minute.

Other: Automated variable dose oxygen treatment

Interventions

Automated variable dose oxygen treatment OTHER

The participant will receive closed loop oxygen titration during a walking test based on oxygen saturation measurements every second measured by a pulse oximeter connected to the O2matic. The participant will every minute during the walking test rate sensation of dyspnea on the BorgCR10 scale.

Also known as: Closed loop oxygen titration with O2matic

Endurance shuttle walk test with automated variable dose oxygen treatment

Fixed dose oxygen treatment OTHER

The participant will receive a fixed oxygen dose during a walking test. The participant will every minute during the walking test rate sensation of dyspnea on the BorgCR10 scale.

Endurance shuttle walk test with fixed dose oxygen treatment

Eligibility Criteria

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

You may qualify if:

• Verified diagnosis of fibrotic interstitial lung disease
• Desaturation during a recent (6 months) 6-minute walk test below 88% on atmospheric air or during an incremental shuttle walking test
• Able to walk at least 50 meters
• Self-reported stable respiratory symptoms in the previous 2 weeks
• Age ≥ 18 years
• Cognitively able to understand and participate in the study
• Written informed consent

You may not qualify if:

• Long term oxygen treatment
• A pulmonary or cardiac condition other than fibrotic interstitial lung disease limiting exercise performance
• Unstable heart condition or symptomatic stenotic valve disease
• Any physical condition limiting exercise performance.
• Smoking the previous 24 hours
• Pregnancy
• Anaemia, haemoglobin \< 7.3 mmol/l (women) or \< 8.3 mmol/l (men)

Sponsors & Collaborators

• Janne Hastrup Jensen: lead
• Copenhagen University Hospital, Hvidovre: collaborator

Study Sites (1)

Aarhus University Hospital

Aarhus, 8200, Denmark

Location

Related Publications (12)

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  PMID: 24836312 BACKGROUND

• Kofod LM, Westerdahl E, Kristensen MT, Brocki BC, Ringbaek T, Hansen EF. Effect of Automated Oxygen Titration during Walking on Dyspnea and Endurance in Chronic Hypoxemic Patients with COPD: A Randomized Crossover Trial. J Clin Med. 2021 Oct 20;10(21):4820. doi: 10.3390/jcm10214820.

  PMID: 34768338 BACKGROUND

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  PMID: 27794080 BACKGROUND

• Raghu G, Collard HR, Egan JJ, Martinez FJ, Behr J, Brown KK, Colby TV, Cordier JF, Flaherty KR, Lasky JA, Lynch DA, Ryu JH, Swigris JJ, Wells AU, Ancochea J, Bouros D, Carvalho C, Costabel U, Ebina M, Hansell DM, Johkoh T, Kim DS, King TE Jr, Kondoh Y, Myers J, Muller NL, Nicholson AG, Richeldi L, Selman M, Dudden RF, Griss BS, Protzko SL, Schunemann HJ; ATS/ERS/JRS/ALAT Committee on Idiopathic Pulmonary Fibrosis. An official ATS/ERS/JRS/ALAT statement: idiopathic pulmonary fibrosis: evidence-based guidelines for diagnosis and management. Am J Respir Crit Care Med. 2011 Mar 15;183(6):788-824. doi: 10.1164/rccm.2009-040GL.

  PMID: 21471066 BACKGROUND

• Schneeberger T, Jarosch I, Leitl D, Gloeckl R, Hitzl W, Dennis CJ, Geyer T, Criee CP, Koczulla AR, Kenn K. Automatic oxygen titration versus constant oxygen flow rates during walking in COPD: a randomised controlled, double-blind, crossover trial. Thorax. 2023 Apr;78(4):326-334. doi: 10.1136/thoraxjnl-2020-216509. Epub 2021 Oct 16.

  PMID: 34656996 BACKGROUND

• Vezina FA, Bouchard PA, Breton-Gagnon E, Dion G, Viglino D, Roy P, Bilodeau L, Provencher S, Denault MH, Saey D, Lellouche F, Maltais F. Automated O2 Titration Alone or With High-Flow Nasal Cannula During Walking Exercise in Chronic Lung Diseases. Respir Care. 2023 Dec 28;69(1):1-14. doi: 10.4187/respcare.10810.

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• Visca D, Mori L, Tsipouri V, Fleming S, Firouzi A, Bonini M, Pavitt MJ, Alfieri V, Canu S, Bonifazi M, Boccabella C, De Lauretis A, Stock CJW, Saunders P, Montgomery A, Hogben C, Stockford A, Pittet M, Brown J, Chua F, George PM, Molyneaux PL, Margaritopoulos GA, Kokosi M, Kouranos V, Russell AM, Birring SS, Chetta A, Maher TM, Cullinan P, Hopkinson NS, Banya W, Whitty JA, Adamali H, Spencer LG, Farquhar M, Sestini P, Wells AU, Renzoni EA. Effect of ambulatory oxygen on quality of life for patients with fibrotic lung disease (AmbOx): a prospective, open-label, mixed-method, crossover randomised controlled trial. Lancet Respir Med. 2018 Oct;6(10):759-770. doi: 10.1016/S2213-2600(18)30289-3. Epub 2018 Aug 28.

  PMID: 30170904 BACKGROUND

• Vivodtzev I, L'Her E, Vottero G, Yankoff C, Tamisier R, Maltais F, Lellouche F, Pepin JL. Automated O2 titration improves exercise capacity in patients with hypercapnic chronic obstructive pulmonary disease: a randomised controlled cross-over trial. Thorax. 2019 Mar;74(3):298-301. doi: 10.1136/thoraxjnl-2018-211967. Epub 2018 Aug 30.

  PMID: 30166425 BACKGROUND

MeSH Terms

Conditions

Pulmonary Fibrosis

Condition Hierarchy (Ancestors)

Lung Diseases, Interstitial; Lung Diseases; Respiratory Tract Diseases; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Janne H Jensen, MSc

  Aarhus University Hospital, Department of Physiotherapy and Occopational therapy

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The participant will wear a high flow nasal canula for oxygen treatment during both endurance shuttle walk tests, which will mask the mode of oxygen delivery and dose for both the participant and the assessor (investigator). A health care professional not involved in the data collection or outcome assessment will set up the equipment before each test to secure masking of the O2matic device and oxygen delivery mode.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Physiotherapist

Model Details: In random order the participants will conduct the endurance shuttle walk test with either fixed dose oxygen treatment or automated oxygen titration treatment

Study Record Dates

• First Submitted: May 27, 2024
• First Posted: June 20, 2024
• Study Start: June 20, 2024
• Primary Completion: September 10, 2025
• Study Completion: September 10, 2025
• Last Updated: October 2, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)