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| Name | Class |
|---|---|
| Örebro University, Sweden | OTHER |
| University Hospital Bispebjerg and Frederiksberg | OTHER |
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The purpose of this study is to examine the effect of automated oxygen titration compared to the usual fixed dose oxygen on the patient's ability to perform activities of daily living.
The patient's ability to perform ADL assessed by the Glittre-ADL test with automatic oxygen titration compared to usual fixed dose will be examined.
The patients will be invited to a visit at one of the participating hospitals. The Glittre-ADL will be performed according to the protocol validated by Skumlien et al. The first test is performed for familiarization in order to avoid a learning effect in the primary tests. The patients will use the fixed-dose oxygen, established after titration to a SpO2 of 90-94 % at rest.
After the familiarization test and gathering of demographics, further two Glittre-ADL tests will be performed on the same day or at another day pending on patient preference. In random order the patients will use A) automated oxygen titration set at an SpO2-target of 90 to 94 % and an oxygen flow of 0 - 8 liters/min and B) their usual fixed dose of oxygen. In both arms O2matic will monitor pulse rate and saturation continuously during the test, but only in the automated oxygen therapy arm O2matic adjusts the oxygen flow. The patients will all use a rollator as walking aid. The oxygen equipment will be placed in the rollator and the tests will be conducted without the steps (due to the use of rollator). The minimum interval between tests will be 20 minutes or until the vital values and symptoms are returned to baseline. Before, and after the Glittre-ADL, the patients will be asked the rate their level of dyspnea using Borg Dyspnea Scale.
Study Analysis Plan
Variables will be examined for normality and analyzed with either a paired t-test (in case of normality) or Wilcoxon-signed-rank test (in case of non-normality). The median of the differences between tests will be used for a value. The number of patients who reach a Minimal Clinically Important Difference (MCID) in either the Dyspnea score or in time used in the Glittre test will be reported.
Difference in time spent within saturation intervals will be extracted from the CSV files and combined using Excel.
IBM SPSS Statistics for Windows, ver. 29.0.1.0 will be used for all statistical analyses.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Usual oxygen dose | No Intervention | A Glittre-ADL tests will be performed and the patients will use their usual fixed dose of oxygen. Pulse rate and saturation will continuously be registered during the test. Before, and after the Glittre-ADL, the patients will be asked the rate their level of dyspnea using Borg Dyspnea Scale | |
| Automated oxygen dose | Experimental | A Glittre-ADL tests will be performed and the patients will use automated oxygen titration set at an SpO2-target of 90 to 94 % and an oxygen flow of 0 - 8 liters/min. Pulse rate, oxygen flow rate and saturation will continuously be registered during the test. Before, and after the Glittre-ADL, the patients will be asked the rate their level of dyspnea using Borg Dyspnea Scale |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Automated oxygen titration based on the oxygen saturation during activity | Other | A device will be used, which automatically adjusts the oxygen flow to the dosage necessary for keeping the saturation at the recommended level (90-94%). If the saturation falls below 90%, oxygen flow will increase, and if the saturation increases above 94%, oxygen flow decreases in order to stay on target. |
| Measure | Description | Time Frame |
|---|---|---|
| Time used for the Glittre-ADL test | Change in time used to complete the Glittre-ADL test with automated titration compared to fixed-dose treatment | Immediately after intervention (control arm test and automated oxygen titration arm) on the same day |
| Measure | Description | Time Frame |
|---|---|---|
| Dyspnea | Change in Dyspnea Borg (in units from 0-10) scores after performing Glittre ADL test between arms | Immediately after the intervention |
| Saturation | Change in time spent within acceptable SpO2-interval (SpO2 90 - 94 %) and time spent with moderate hypoxemia (SpO2 < 88 %) and severe hypoxemia (SpO2 < 85 %) in the two Glittre-ADL tests |
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Inclusion Criteria:
Verified history of COPD with FEV1/FVC < 0.70 and FEV1 < 50 %
Hypoxemic at rest (SpO2≤ 90 %) and fulfilment of general national criteria for LTOT
Able to walk at least 30 meters
Age >18, Cognitively able to participate in the study and willing to give informed consent
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Linette M Kofod | Hvidovre University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Copenhagen University Hospital, Hvidovre | Hvidovre | 2650 | Denmark |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40473413 | Derived | Kofod LM, Hansen EF, Brocki BC, Kristensen MT, Roberts NB, Westerdahl E. Optimised oxygenation improves functional capacity during daily activities in patients with COPD on long-term oxygen therapy: a randomised crossover trial. Thorax. 2025 Oct 15;80(11):803-809. doi: 10.1136/thorax-2024-221883. |
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Data could be available on reasonable request, but needs to follow the rules set by the danish Data Protection Agency.
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| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
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multicentre double blinded randomized crossover trial
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The patient will be blinded for the oxygen supply. An independent person will prepare the oxygen setup with usual fixed dose or automated titration. The setup i covered. The assessor conducting the tests is blinded.
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| Immediately after the intervention |
| Oxygen consumption | Change in average oxygen consumption between the two tests | Immediately after the intervention |
| D020969 |
| Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001519 | Behavior |