Heart DiseasesO2matic-CardNCT05452863
O2matic Cardiology Protocol
A study testing O2matic administered oxygen and Manual oxygen supply and adjustments in people with Heart Diseases, run by Hvidovre University Hospital at 1 site in Denmark.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 30 years and older
- Conditions the study is for
- Heart Diseases
- What is being tested?
- O2matic administered oxygen and Manual oxygen supply and adjustments
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Mar 2022to 18 Mar 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with heart disease and an oxygen saturation below 94% admitted to the Department of Cardiology
- Age of 30 or more
- Intellectual capacity to participate in the trial
- Willing to give informed accept of participation in the trial.
Who cannot join
- Unstable patients
- Need for ventilatory support except intermittent continuous positive airway pressure
- Fertile women (age<55 years) with a positive pregnancy test
- Unable to participate due to language or cognitive problems
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Amager and Hvidovre Hospital University of Copenhagen
Copenhagen, DK-2650
About this study
Official title: Automatic Oxygen Supply With the O2matic Device for the Treatment of Hospitalized Heart Patients With Hypoxia
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.
Read the detailed description
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.
- Conditions
- Heart Diseases
- Being tested
- O2matic administered oxygen, Manual oxygen supply and adjustments
- Keywords
- hypoxemia, cardiology, automatic oxygen supply
- Medical subject headings
- Heart Diseases, Hypoxia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
O2matic administered oxygenDevice
Oxygen supply is adjusted from an almost continuous measurement of the oxygen saturation with an appropriate an previously tested algorithm.
Manual oxygen supply and adjustmentsDevice
Oxygen supply is adjusted from manual measurements of the oxygen saturation
| Study group | Role | What they receive |
|---|---|---|
| Automatic oxygen supply | Active comparator | Oxygen will be supplied by the O2matic device Receives: Device: O2matic administered oxygen |
| Manual oxygen supply | Placebo comparator | Oxygen will be supplied by nurse adjustments in the usual way Receives: Device: Manual oxygen supply and adjustments |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time in designated saturation interval
We have predefined an optimum saturation interval of 92-96% with a target of 93%
Measured: 24 hours of treatment
Secondary outcomes (3)
Time with hypoxemia
Time with saturation below 92% but above 85%
Measured: 24 hours of treatment
Time with severe hypoxemia
Time with saturation below 85%
Measured: 24 hours of treatment
Time with hyperoxemia
Time with saturation above 96%
Measured: 24 hours of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2022
- Study start1 Mar 2022
- Primary completion18 Mar 2023
- Study completion18 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Heart DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized, open-label study
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hvidovre University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jens D Hove, MD,PHD, Hvidovre University Hospital
- Investigators
- Jens D Hove, MD, PhD, Principal investigator, Amager-Hvidovre Universitetshospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05452863
- Sponsor's protocol ID
- H-19033702
- Acronym
- O2matic-Card
- Status last verified
- Sep 2024
- First submitted
- 4 Jul 2022
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 33144929Kofod 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.
PubMed 34768338Hansen 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.
PubMed 30587955Taraldsen 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.
PubMed 39486892Taraldsen 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.
PubMed 36999819
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Automatic Oxygen Supply With the O2matic Device for the Treatment of Hospitalized Heart Patients With Hypoxia
- ClinicalTrials.gov ID
- NCT05452863
- Acronym / sponsor ID
- O2matic-Card / H-19033702
- Conditions
- Heart Diseases
- Keywords
- hypoxemia, cardiology, automatic oxygen supply
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Hvidovre University HospitalUniversity, hospital or other
- Study start
- 1 Mar 2022 (actual)
- Primary completion
- 18 Mar 2023 (actual)
- Study completion
- 18 Mar 2024 (actual)
- First posted
- 11 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized, open-label study
| Arm | Type | Receives |
|---|---|---|
| Automatic oxygen supply | Active comparator | Device: O2matic administered oxygenOxygen will be supplied by the O2matic device |
| Manual oxygen supply | Placebo comparator | Device: Manual oxygen supply and adjustmentsOxygen will be supplied by nurse adjustments in the usual way |
Who may qualify
- Ages
- 30 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients with heart disease and an oxygen saturation below 94% admitted to the Department of Cardiology
- Age of 30 or more
- Intellectual capacity to participate in the trial
- Willing to give informed accept of participation in the trial.
Key exclusion criteria (4 listed)
- Unstable patients
- Need for ventilatory support except intermittent continuous positive airway pressure
- Fertile women (age<55 years) with a positive pregnancy test
- Unable to participate due to language or cognitive problems
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| O2matic administered oxygenOxygen supply is adjusted from an almost continuous measurement of the oxygen saturation with an appropriate an previously tested algorithm. | Device | Automatic oxygen supply |
| Manual oxygen supply and adjustmentsOxygen supply is adjusted from manual measurements of the oxygen saturation | Device | Manual oxygen supply |
Primary outcome
Time in designated saturation interval
Time frame: 24 hours of treatment
We have predefined an optimum saturation interval of 92-96% with a target of 93%
3 secondary outcomes
Time with hypoxemia
Time frame: 24 hours of treatment
Time with severe hypoxemia
Time frame: 24 hours of treatment
Time with hyperoxemia
Time frame: 24 hours of treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Background: PubMed 33144929Hansen 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.
- Background: PubMed 34768338Kofod 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.
- Results publication: PubMed 30587955Hansen 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.
- Derived from this study: PubMed 39486892Taraldsen 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.
- Derived from this study: PubMed 36999819Taraldsen 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.
- Description of the deviceLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jens D Hove, MD, PhD principal investigator
Amager-Hvidovre Universitetshospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing O2matic administered oxygen and Manual oxygen supply and adjustments in people with Heart Diseases, run by Hvidovre University Hospital at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time in designated saturation interval (time frame: 24 hours of treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05452863, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2024.