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

Официальное название

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)

Обзор

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.

Подробное описание

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.

Вмешательства

• Устройство Continous Oxygen by Bottles
  Oxygen delivery by bottles giving a continous flow.
• Устройство Demand oxygen by Portable Concentrator
  Oxygen delivery by consentrators, giving oxygen only when inhaling.

Первичные конечные точки

• Lowest oxygen [Срок оценки: At Baseline]

Вторичные конечные точки (12)

• percentage of saturation <90% [Срок оценки: At baseline]
• minutes of saturation <90% [Срок оценки: At baseline]
• minimum value of oxygen [Срок оценки: At baseline]
• Pulse rate [Срок оценки: At baseline]
• Maximum pulse rate [Срок оценки: At baseline]
• Distance [Срок оценки: At baseline]
• time to recover [Срок оценки: At baseline]
• Maximal Borg scale [Срок оценки: At baseline]
• Change Borg scale [Срок оценки: At baseline]
• Patient preference [Срок оценки: At baseline]
• Comfort Likert scale [Срок оценки: At baseline]
• Reliability Likert scale [Срок оценки: At baseline]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Перекрёстный дизайн

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Публикации

• 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

Идентификаторы

NCT: NCT06767904 · OXYCODE

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗