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OpenTrials
Completed

NCT Number: NCT04565106

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

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.

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Key information

Conditions

Covid19 COVID-19 Coronaviridae Infections Coronavirus Infections Hypoxemia Hypoxemic Respiratory Failure Hypoxia Infections Lung Diseases Nidovirales Infections Pathological Conditions, Signs and Symptoms Pneumonia Pneumonia, Viral RNA Virus Infections Respiration Disorders Respiratory Insufficiency Respiratory Tract Diseases Respiratory Tract Infections Signs and Symptoms Signs and Symptoms, Respiratory Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hvidovre University Hospital

Copenhagen, 3550, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Closed-loop control of oxygen supplementation by O2matic

Device

Closed-loop control of oxygen supplementation to achieve a target SpO2 of 92 - 96 %

Primary outcomes

  1. Time in SpO2 target

    Time frame: 1 week

    Time in SpO2 target of 92-96 %

Secondary outcomes

  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 %

Sponsors and collaborators

Lead sponsor

Hvidovre University Hospital

Other

Collaborators

  • Innovation Fund Denmark

Registry information

Acronym: O2matic-COVI

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Sep 25, 2020
Registry last updated
Sep 25, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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