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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Covid19, Hypoxemic Respiratory Failure, Hypoxemia

Intervention / Treatment
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* Device: Closed-loop control of oxygen supplementation by O2matic


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Closed-loop control of oxygen supplementation by O2matic|Closed-loop control of oxygen supplementation to achieve a target SpO2 of 92 - 96 %|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time in SpO2 target | Time in SpO2 target of 92-96 % | 1 week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time with SpO2 not more than 2 % outside target | Time with SpO2 not more than 2 % outside target | 1 week | 
| Time with SpO2 more than 2 % outside target | Time with SpO2 more than 2 % outside target | 1 week | 
| Time with SpO2 < 85 % | Time with SpO2 < 85 % | 1 week | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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O2matic, Closed-loop