Automated Oxygen Titration in Daily Life in Patients With COPD on Home Oxygen
NCT ID: NCT05553847
Last Updated: 2023-11-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
32 participants
INTERVENTIONAL
2022-10-30
2023-11-14
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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
1. Paired sample t-test: time used in the Glittre test using AutOx vs Time used using Fixed oxygen (in seconds)
2. Paired sample t-test: Borg score after Glittre using Autox vs Borg score after Glittre when using Fixed oxygen (on a scale from 0-10) A test for carryover effect will be performed by comparing the first and the second tests before being divided into the Autox and fixed oxygen groups.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
CROSSOVER
TREATMENT
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Automated oxygen dose
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
Automated oxygen titration based on the oxygen saturation during activity
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.
Usual oxygen dose
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
No interventions assigned to this group
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Automated oxygen titration based on the oxygen saturation during activity
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.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Hypoxemic at rest (SpO2≤ 90 %) and fulfilment of general national criteria for LTOT
* Partial pressure of Oxygen (PaO2) (without oxygen supplement) ≤7.3 kPa in clinically stable and optimally treated condition
* Increase in PaO2 after oxygen supplementation (to 8.0-9.0 kPa) without decrease in arterial pH (\> 0.03 kPa)
* The oxygen is used at least 15 hours daily (optimally 24 hours daily)
* The treatment is handled by hospital departments with lung medical expertise.
* Able to walk at least 30 meters
* Age \>18, Cognitively able to participate in the study and willing to give informed consent
Exclusion Criteria
* Unstable heart condition or stenotic aortic valve disease
* A physical condition including paralysis, lower extremity pain, or back problem limiting physical performance
* Exacerbation in COPD treated with either antibiotics or prednisolone within the last 3 weeks
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Örebro University, Sweden
OTHER
University Hospital Bispebjerg and Frederiksberg
OTHER
Hvidovre University Hospital
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Linette Marie Kofod
Physiotherapist, Primary investigator
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Linette M Kofod
Role: PRINCIPAL_INVESTIGATOR
Hvidovre University Hospital
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Copenhagen University Hospital, Hvidovre
Hvidovre, , Denmark
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
Fys1977
Identifier Type: -
Identifier Source: org_study_id