Covid19O2matic-COVINCT04565106
Automatic Oxygen Titration With O2matic® to Patients Admitted With COVID-19 and Hypoxemic Respiratory Failure
An observational study of Covid19 and Hypoxemic Respiratory Failure, run by Hvidovre University Hospital at 1 site in Denmark.
Trial summary
Patients with coronavirus disease (COVID-19) and pneumonitis often have hypoxemic respiratory failure and a need of supplementary oxygen. Guidelines recommend controlled oxygen, for most patients with a recommended interval of SpO2 between 92 and 96 %. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Covid19, Hypoxemic Respiratory Failure, Hypoxemia
- Type of treatment
- Medical device
- How many people
- 16 participants
- Where
- 1 siteDenmark
- Study dates
- 15 Apr 2020to 31 May 2020
- Phase
- Observational
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients admitted with COVID-19 pneumonitis and in need of oxygen supplementation
Who may be able to join
- Older than 18 years
- Positive COVID-19 PCR analysis in pharyngeal swab or in tracheal secretion
- Need oxygen supply to maintain SpO2 ≥ 92 %
- Able to comply with continuous measurement of SpO2 by pulse oximetry.
Who cannot join
- Need of oxygen supply > 10 liters/min at admission
Trial locations and contacts
1 site in 1 country.
About this study
Patients with coronavirus disease (COVID-19) and pneumonitis often have hypoxemic respiratory failure and a need of supplementary oxygen. Guidelines recommend controlled oxygen, for most patients with a recommended interval of SpO2 between 92 and 96 %. We aimed to determine if closed-loop control of oxygen was feasible in patients with COVID-19 and could maintain SpO2 in the specified interval.
Read the detailed description
Patients with coronavirus disease (COVID-19) and pneumonitis often have hypoxemic respiratory failure and a need of supplementary oxygen. Guidelines recommend controlled oxygen, for most patients with a recommended interval of SpO2 between 92 and 96 %. We aimed to determine if closed-loop control of oxygen was feasible in patients with COVID-19 and could maintain SpO2 in the specified interval.
Patients were prospectively enrolled in an observational study on a medical ward dedicated to patients with COVID-19. Closed-loop controlled oxygen was delivered by O2matic® which can deliver 0-15 liters/min and adjusts flow every second based on 15 seconds averaging of SpO2 measured by pulse oximetry. Lung function parameters were measured at admission.
- Conditions
- Covid19, Hypoxemic Respiratory Failure, Hypoxemia
- Being tested
- Closed-loop control of oxygen supplementation by O2matic
- Keywords
- O2matic, Closed-loop
- Medical subject headings
- COVID-19, Respiratory Insufficiency, Hypoxia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Closed-loop control of oxygen supplementation by O2maticDevice
Closed-loop control of oxygen supplementation to achieve a target SpO2 of 92 - 96 %
What is being measured
The primary outcome is the main question the study is designed to answer.
Time in SpO2 target
Time in SpO2 target of 92-96 %
Measured: 1 week
Secondary outcomes (3)
Time with SpO2 not more than 2 % outside target
Time with SpO2 not more than 2 % outside target
Measured: 1 week
Time with SpO2 more than 2 % outside target
Time with SpO2 more than 2 % outside target
Measured: 1 week
Time with SpO2 < 85 %
Time with SpO2 < 85 %
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2020
- Study start15 Apr 2020
- Primary completion31 May 2020
- Study completion31 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Covid19Studies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hvidovre University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Innovation Fund Denmark
- Responsible party
- Principal investigator, Ejvind Frausing Hansen, Hvidovre University Hospital
- Investigators
- Ove Andersen, PhD, Study chair, Hvidovre University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04565106
- Sponsor's protocol ID
- O2matic-COVID
- Acronym
- O2matic-COVI
- Status last verified
- Sep 2020
- First submitted
- 24 Sep 2020
- Last updated
- 25 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Automatic Oxygen Titration With O2matic® to Patients Admitted With COVID-19 and Hypoxemic Respiratory Failure
- ClinicalTrials.gov ID
- NCT04565106
- Acronym / sponsor ID
- O2matic-COVI / O2matic-COVID
- Conditions
- Covid19, Hypoxemic Respiratory Failure, Hypoxemia
- Keywords
- O2matic, Closed-loop
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Hvidovre University HospitalUniversity, hospital or other
- Collaborators
- Innovation Fund Denmark
- Study start
- 15 Apr 2020 (actual)
- Primary completion
- 31 May 2020 (actual)
- Study completion
- 31 May 2020 (actual)
- First posted
- 25 Sep 2020 (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.
Patients with coronavirus disease (COVID-19) and pneumonitis often have hypoxemic respiratory failure and a need of supplementary oxygen. Guidelines recommend controlled oxygen, for most patients with a recommended interval of SpO2 between 92 and 96 %. We aimed to determine if closed-loop control of oxygen was feasible in patients with COVID-19 and could maintain SpO2 in the specified interval.
Detailed description
Patients with coronavirus disease (COVID-19) and pneumonitis often have hypoxemic respiratory failure and a need of supplementary oxygen. Guidelines recommend controlled oxygen, for most patients with a recommended interval of SpO2 between 92 and 96 %. We aimed to determine if closed-loop control of oxygen was feasible in patients with COVID-19 and could maintain SpO2 in the specified interval.
Patients were prospectively enrolled in an observational study on a medical ward dedicated to patients with COVID-19. Closed-loop controlled oxygen was delivered by O2matic® which can deliver 0-15 liters/min and adjusts flow every second based on 15 seconds averaging of SpO2 measured by pulse oximetry. Lung function parameters were measured at admission.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients admitted with COVID-19 pneumonitis and in need of oxygen supplementation
Key inclusion criteria (4 listed)
- Older than 18 years
- Positive COVID-19 PCR analysis in pharyngeal swab or in tracheal secretion
- Need oxygen supply to maintain SpO2 ≥ 92 %
- Able to comply with continuous measurement of SpO2 by pulse oximetry.
Key exclusion criteria (1 listed)
- Need of oxygen supply > 10 liters/min at admission
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 |
|---|---|---|
| Closed-loop control of oxygen supplementation by O2maticClosed-loop control of oxygen supplementation to achieve a target SpO2 of 92 - 96 % | Device | – |
Primary outcome
Time in SpO2 target
Time frame: 1 week
Time in SpO2 target of 92-96 %
3 secondary outcomes
Time with SpO2 not more than 2 % outside target
Time frame: 1 week
Time with SpO2 more than 2 % outside target
Time frame: 1 week
Time with SpO2 < 85 %
Time frame: 1 week
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 25 Sep 2020.
- 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.
Ove Andersen, PhD study chair
Hvidovre University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Covid19 and Hypoxemic Respiratory Failure, 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 1 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 25 Sep 2020. 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. 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 SpO2 target (time frame: 1 week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 25 Sep 2020.