Automated Oxygen Titration During Walking in Patients With Lung Fibrosis (OXYWILD)
NCT Number: NCT06465654
Acronym: OXYWILD
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Fibrosis Lung|Respiratory Therapy
Interventions: OTHER: Automated variable dose oxygen treatment|OTHER: Fixed dose oxygen treatment
Sponsor: Janne Hastrup Jensen
Collaborators: Copenhagen University Hospital, Hvidovre
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 28
Study Design: Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-06-20
Completion Date: 2026-04-15
Locations: Aarhus University Hospital, Aarhus, 8200, Denmark

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.

Primary Outcome Measures: 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 Outcome Measures: Walking distance, Difference in walking distance in meters between groups in Endurance shuttle walking test, At baseline and through completion (one day)|Walking time, Difference in walking time in seconds between groups in Endurance shuttle walking test, At baseline and through completion (one day)|Oxygen flow rate, Difference in average oxygen flow rate (liter/minute) between groups in Endurance shuttle walking test., At baseline and through completion (one day)|Oxygen saturation levels, Difference in time spent in seconds within acceptable oxygen saturation interval (oxygen saturation 90 - 94 percentage and time spent with moderate hypoxemia (oxygen saturation below 88 percentage) and severe hypoxemia (Oxygen saturation below 85 percentage) with moderate hypoxemia (oxygen saturation below 88 percentage) and severe hypoxemia (oxygen saturation below 85 percentage., At baseline and through completion (one day)|Hypoxemia, Time to first moderate hypoxemia and severe hypoxemia, At baseline and through completion (one day)|Difference in causes of walking limitations, The participant is asked about factors limiting the walking distance., At baseline and through completion (one day)