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

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ClinicalTrials.gov Identifier: NCT04565106
Recruitment Status : Completed
First Posted : September 25, 2020
Last Update Posted : September 25, 2020
Sponsor:
Collaborator:
Innovation Fund Denmark
Information provided by (Responsible Party):
Ejvind Frausing Hansen, Hvidovre University Hospital

Study Description
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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.

Condition or disease Intervention/treatment
Covid19 Hypoxemic Respiratory Failure Hypoxemia Device: Closed-loop control of oxygen supplementation by O2matic

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 Design
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Study Type : Observational
Actual Enrollment : 16 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Automatic Oxygen Titration With O2matic® to Patients Admitted With COVID-19 and Hypoxemic Respiratory Failure
Actual Study Start Date : April 15, 2020
Actual Primary Completion Date : May 31, 2020
Actual Study Completion Date : May 31, 2020

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

Outcome Measures
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Primary Outcome Measures :
  1. Time in SpO2 target [ Time Frame: 1 week ]
    Time in SpO2 target of 92-96 %


Secondary Outcome Measures :
  1. Time with SpO2 not more than 2 % outside target [ Time Frame: 1 week ]
    Time with SpO2 not more than 2 % outside target

  2. Time with SpO2 more than 2 % outside target [ Time Frame: 1 week ]
    Time with SpO2 more than 2 % outside target

  3. Time with SpO2 < 85 % [ Time Frame: 1 week ]
    Time with SpO2 < 85 %


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients admitted with COVID-19 pneumonitis and in need of oxygen supplementation
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04565106


Locations
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Denmark
Hvidovre University Hospital
Copenhagen, Denmark, 3550
Sponsors and Collaborators
Hvidovre University Hospital
Innovation Fund Denmark
Investigators
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Study Chair: Ove Andersen, PhD Hvidovre University Hospital
More Information
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Responsible Party: Ejvind Frausing Hansen, Chief Physician, Hvidovre University Hospital
ClinicalTrials.gov Identifier: NCT04565106    
Other Study ID Numbers: O2matic-COVID
First Posted: September 25, 2020    Key Record Dates
Last Update Posted: September 25, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Ejvind Frausing Hansen, Hvidovre University Hospital:
O2matic
Closed-loop
Additional relevant MeSH terms:
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Respiratory Insufficiency
Hypoxia
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory