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Automatic oxygen supply with the O2matic device has been shown to provided an enhanced oxygen treatment in patients with hypoxemia. O2matic was significantly better than manual control to maintain oxygen saturation within target interval and to reduce time with unintended hypoxemia in patients suffering from chronic obstructive pulmonary disease. This trial investigates the effect of using O2matic in hypoxic patients submitted to the Department of Cardiology.
Oxygen supply to patients with cardiovascular disease has been subject to several investigations. Both too much and too little oxygen is supposed to be harmful. The O2matic device is a new way of supplying oxygen treatment which is significantly better than manual control to maintain oxygen saturation within target interval and to reduce time with unintended hypoxemia. The device has past favorable tests in patients suffering from chronic obstructive pulmonary disease. This study investigates the application of the O2matic device on hypoxic patients admitted to the Cardiology ward.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Automatic oxygen supply | Active Comparator | Oxygen will be supplied by the O2matic device |
|
| Manual oxygen supply | Placebo Comparator | Oxygen will be supplied by nurse adjustments in the usual way |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| O2matic administered oxygen | Device | Oxygen supply is adjusted from an almost continuous measurement of the oxygen saturation with an appropriate an previously tested algorithm. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Time in designated saturation interval | We have predefined an optimum saturation interval of 92-96% with a target of 93% | 24 hours of treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Time with hypoxemia | Time with saturation below 92% but above 85% | 24 hours of treatment |
| Time with severe hypoxemia | Time with saturation below 85% |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jens D Hove, MD, PhD | Amager-Hvidovre Universitetshospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Amager and Hvidovre Hospital University of Copenhagen | Copenhagen | DK-2650 | Denmark |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33144929 | Background | Hansen EF, Bech CS, Vestbo J, Andersen O, Kofod LM. Automatic oxygen titration with O2matic(R) to patients admitted with COVID-19 and hypoxemic respiratory failure. Eur Clin Respir J. 2020 Oct 14;7(1):1833695. doi: 10.1080/20018525.2020.1833695. | |
| 34768338 | Background | Kofod LM, Westerdahl E, Kristensen MT, Brocki BC, Ringbaek T, Hansen EF. Effect of Automated Oxygen Titration during Walking on Dyspnea and Endurance in Chronic Hypoxemic Patients with COPD: A Randomized Crossover Trial. J Clin Med. 2021 Oct 20;10(21):4820. doi: 10.3390/jcm10214820. |
| Label | URL |
|---|---|
| Description of the device | View source |
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| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D000860 | Hypoxia |
| ID | Term |
|---|---|
| D002318 | Cardiovascular Diseases |
| D012818 | Signs and Symptoms, Respiratory |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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Randomized, open-label study
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| Manual oxygen supply and adjustments | Device | Oxygen supply is adjusted from manual measurements of the oxygen saturation |
|
| 24 hours of treatment |
| Time with hyperoxemia | Time with saturation above 96% | 24 hours of treatment |
| 30587955 | Result | Hansen EF, Hove JD, Bech CS, Jensen JS, Kallemose T, Vestbo J. Automated oxygen control with O2matic(R) during admission with exacerbation of COPD. Int J Chron Obstruct Pulmon Dis. 2018 Dec 14;13:3997-4003. doi: 10.2147/COPD.S183762. eCollection 2018. |
| 39486892 | Derived | Taraldsen IA, Grand J, Lukoschewitz JD, Seven E, Dixen U, Petersen M, Rytoft L, Jakobsen MM, Hansen EF, Hove JD. Automated oxygen administration versus manual control in acute cardiovascular care: a randomised controlled trial. Heart. 2024 Dec 13;111(1):27-34. doi: 10.1136/heartjnl-2024-324488. |
| 36999819 | Derived | Taraldsen IA, Grand J, Lukoschewitz JD, Hansen EF, Hove JD. Automated versus manual oxygen administration for patients admitted with acute cardiovascular disease - a study protocol of a randomised controlled trial. Dan Med J. 2023 Mar 27;70(4):A12220784. |