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Automatic Oxygen Titration With O2matic® to Patients Admitted With COVID-19 and Hypoxemic Respiratory Failure

Automatic Oxygen Titration With O2matic® to Patients Admitted With COVID-19 and Hypoxemic Respiratory Failure

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04565106
Acronym
O2matic-COVI
Enrollment
16
Registered
2020-09-25
Start date
2020-04-15
Completion date
2020-05-31
Last updated
2020-09-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Covid19, Hypoxemia, Hypoxemic Respiratory Failure

Keywords

O2matic, Closed-loop

Brief 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 %. 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.

Interventions

DEVICEClosed-loop control of oxygen supplementation by O2matic

Closed-loop control of oxygen supplementation to achieve a target SpO2 of 92 - 96 %

Sponsors

Innovation Fund Denmark
CollaboratorINDIV
Hvidovre University Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* 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.

Exclusion criteria

* Need of oxygen supply \> 10 liters/min at admission

Design outcomes

Primary

MeasureTime frameDescription
Time in SpO2 target1 weekTime in SpO2 target of 92-96 %

Secondary

MeasureTime frameDescription
Time with SpO2 not more than 2 % outside target1 weekTime with SpO2 not more than 2 % outside target
Time with SpO2 more than 2 % outside target1 weekTime with SpO2 more than 2 % outside target
Time with SpO2 < 85 %1 weekTime with SpO2 \< 85 %

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026