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Clinical Trials/NCT04565106
NCT04565106
Completed
Not Applicable

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

Hvidovre University Hospital1 site in 1 country16 target enrollmentApril 15, 2020

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Covid19
Sponsor
Hvidovre University Hospital
Enrollment
16
Locations
1
Primary Endpoint
Time in SpO2 target
Status
Completed
Last Updated
5 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
April 15, 2020
End Date
May 31, 2020
Last Updated
5 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Ejvind Frausing Hansen

Chief Physician

Hvidovre University Hospital

Eligibility Criteria

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

Outcomes

Primary Outcomes

Time in SpO2 target

Time Frame: 1 week

Time in SpO2 target of 92-96 %

Secondary Outcomes

  • Time with SpO2 < 85 %(1 week)
  • Time with SpO2 not more than 2 % outside target(1 week)
  • Time with SpO2 more than 2 % outside target(1 week)

Study Sites (1)

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