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

Covid19 Clinical Trial

— O2matic-COVI  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04565106
• Other study ID #: O2matic-COVID
• Status: Completed
• Start date: April 15, 2020
• Est. completion date: May 31, 2020

Study information

• Verified date: September 2020
• Source: Hvidovre University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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 %. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: May 31, 2020
• Est. primary completion date: May 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Covid19
• Hypoxemia
• Hypoxemic Respiratory Failure
• Hypoxia
• Respiratory Insufficiency

Intervention

Device:
• Closed-loop control of oxygen supplementation by O2matic
Closed-loop control of oxygen supplementation to achieve a target SpO2 of 92 - 96 %

Locations

Country	Name	City	State
Denmark	Hvidovre University Hospital	Copenhagen

Sponsors (2)

Lead Sponsor	Collaborator
Hvidovre University Hospital	Innovation Fund Denmark

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time in SpO2 target	Time in SpO2 target of 92-96 %	1 week
Secondary	Time with SpO2 not more than 2 % outside target	Time with SpO2 not more than 2 % outside target	1 week
Secondary	Time with SpO2 more than 2 % outside target	Time with SpO2 more than 2 % outside target	1 week
Secondary	Time with SpO2 < 85 %	Time with SpO2 < 85 %	1 week