NCT05556187Completed
Automated Oxygen Titration at Home in Patients With COPD on Home Oxygen
Automated Oxygen Titration in Daily Life of Patients With Chronic Obstructive Pulmonary Disease on Home Oxygen Treatment
Source: ClinicalTrials.gov · Last updated 31 Jan 2024
Brief summary (registry, in English)
Twelwe patients with COPD and long term oxygen treatment (LTOT) will be included in the study. An automated home oxygen titrations (HOT) device will be attached to the patient´s home oxygen equipment. For 2x4 consequent days, the patients will be monitored and saturations, oxygen flow and physical activity level will be registered. In randomized order, the patients will use their usual fixed oxygen dose or automated oxygen titration during the first four days and then crossover. The monitoring consists of a wrist pulse oximeter (register pulse and saturation which is send to the HOT device) and a physical activity sensor attached to the patient's knee. At study start and after both of the four days the patients´dyspnea and QoL will be assessed. After the study period the patients will in an explorative design based on qualitative methodology be interviewed in order to explore the patients experiences with automated oxygen titration during daily activity and on dyspnea.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 12 (actual)
- First submitted
- 22 Sept 2022
- Start date
- 10 Jan 2023
- Primary completion date
- 29 Dec 2023
- Lead sponsor
- Hvidovre University Hospital
- Diseases
- COPD
- NCT number
- NCT05556187
What you commit to
- Study type: Interventional
- Participants enrolled: 12
- From 10 Jan 2023 to the primary completion date, 29 Dec 2023
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Exacerbation in COPD treated with either antibiotics or prednisolone within the last 3 weeks
Other illness
- Pulmonary or cardiac condition other than COPD limiting physical performance
- Unstable heart condition or stenotic aortic valve disease
- A physical condition including paralysis, lower extremity pain, or back problem limiting physical performance
Other
- The patients will also be excluded if they have a drop in pH to \< 7,31 (venous blood gas) on 8 litres per minute of oxygen flow OR an increase in PvCO2 on \> 1 kPa compared to usual fixed oxygen dose.
Who the study is looking for
- 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
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Linette Marie Kofod Coordinator of this site? Confirm its status | Hvidovre | Denmark | Unknown status |
Related publications
- Automated Oxygen Delivery in Home Setting for Patients with COPD on Long-Term Oxygen Therapy - A Randomized Crossover Feasibility Trial.Int J Chron Obstruct Pulmon Dis · 2025 · PMID 41268438
This page is information, not medical advice. Discuss any trial with your doctor.