Chronic Obstructive Pulmonary Disease, Interstitial Lung Disease
Conditions
Keywords
Interstitial Lung Disease, Chronic Obstructive Pulmonary Disease, Oxygen Therapy, Palliation
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.
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.
Interventions
DEVICEContinous Oxygen by Bottles
Oxygen delivery by bottles giving a continous flow.
DEVICEDemand oxygen by Portable Concentrator
Oxygen delivery by consentrators, giving oxygen only when inhaling.
Sponsors
Sissel Kronborg-White
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Lowest oxygen | At Baseline | difference in the lowest oxygen saturation between the two different oxygen delivery systems during a 6-min. walk test. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| percentage of saturation <90% | At baseline | Percentage of time when oxygen levels fall below 90% during walk test. |
| minutes of saturation <90% | At baseline | Number of minutes when saturation falls below 90% during walk test. |
| minimum value of oxygen | At baseline | Minimum value of oxygen saturation during walk test |
| Pulse rate | At baseline | Mean pulse rate during walk test |
| Maximum pulse rate | At baseline | Maximum pulse rate during walk test |
| Distance | At baseline | Difference in walk test distance |
| time to recover | At baseline | The time taken to recover oxygen saturation after walk test to the level obtained at rest |
| Reliability Likert scale | At baseline | 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. |
| Change Borg scale | At baseline | 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) |
| Patient preference | At baseline | Patient preferences for the two different systems (Which system do you prefer? |
| Comfort Likert scale | At baseline | 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. |
| Semi structured qualitative interviews | After 3-6 months | Semi-structured qualitative interviews about patients' view on the different oxygen delivery systems |
| comfort and frequency use oxygen | After 3-6 months | Questions regarding the use of the oxygen delivery systems with respect to comfort and frequency of use |
| Quality of life questionnaire score | After 3-6 months | Change on Quality of life questionnaires between baseline and three to six months |
| Baseline Characteristics | After 3-6 months | Associations between baseline characteristics and effect of and patient views on oxygen delivery systems |
| Maximal Borg scale | At baseline | Maximal rating of dyspnea on the Borg scale (Borg Rating of Percived exertion, range 0-10, where 10 is maximal breathing difficulty). |
Contacts
Primary ContactSissel Kronborg-White, MD, PhD
Outcome results
None listed