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

Completed

• Conditions: Covid19; Hypoxemia; Hypoxemic Respiratory Failure

• Registration Number: NCT04565106
• Lead Sponsor: Hvidovre University Hospital

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.

Study Timeline

• Study Start: 2020-04-15
• Primary Completion: 2020-05-31
• Study Completion: 2020-05-31
• Status Verified: 2020-09
• Study First Submitted: 2020-09-24
• Study First Submitted QC: 2020-09-24
• Last Update Submitted: 2020-09-24
• Study First Posted: 2020-09-25
• Last Update Posted: 2020-09-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 16

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Time in SpO2 target	1 week	Time in SpO2 target of 92-96 %

Secondary Outcome Measures

Name	Time	Method
Time with SpO2 < 85 %	1 week	Time with SpO2 \< 85 %
Time with SpO2 not more than 2 % outside target	1 week	Time with SpO2 not more than 2 % outside target
Time with SpO2 more than 2 % outside target	1 week	Time with SpO2 more than 2 % outside target

Trial Locations

Locations (1)

Hvidovre University Hospital; 🇩🇰 Copenhagen, Denmark