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Completed

NCT Number: NCT05452863

O2matic Cardiology Protocol

Automatic oxygen supply with the O2matic device has been shown to provided an enhanced oxygen treatment in patients with hypoxemia. O2matic was significantly better than manual control to maintain oxygen saturation within target interval and to reduce time with unintended hypoxemia in patients suffering from chronic obstructive pulmonary disease. This trial investigates the effect of using O2matic in hypoxic patients submitted to the Department of Cardiology.

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Key information

Conditions

Heart Diseases Cardiovascular Diseases Hypoxia Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Respiratory

Age range

30 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Amager and Hvidovre Hospital University of Copenhagen

Copenhagen, DK-2650, Denmark

About this study

Oxygen supply to patients with cardiovascular disease has been subject to several investigations. Both too much and too little oxygen is supposed to be harmful. The O2matic device is a new way of supplying oxygen treatment which is significantly better than manual control to maintain oxygen saturation within target interval and to reduce time with unintended hypoxemia. The device has past favorable tests in patients suffering from chronic obstructive pulmonary disease. This study investigates the application of the O2matic device on hypoxic patients admitted to the Cardiology ward.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients with heart disease and an oxygen saturation below 94% admitted to the Department of Cardiology
  • Age of 30 or more
  • Intellectual capacity to participate in the trial
  • Willing to give informed accept of participation in the trial.

Exclusion criteria

  • Unstable patients
  • Need for ventilatory support except intermittent continuous positive airway pressure
  • Fertile women (age<55 years) with a positive pregnancy test
  • Unable to participate due to language or cognitive problems

Treatment and study plan

O2matic administered oxygen

Device

Oxygen supply is adjusted from an almost continuous measurement of the oxygen saturation with an appropriate an previously tested algorithm.

Manual oxygen supply and adjustments

Device

Oxygen supply is adjusted from manual measurements of the oxygen saturation

Primary outcomes

  1. Time in designated saturation interval

    Time frame: 24 hours of treatment

    We have predefined an optimum saturation interval of 92-96% with a target of 93%

Secondary outcomes

  1. Time with hypoxemia

    Time frame: 24 hours of treatment

    Time with saturation below 92% but above 85%

  2. Time with severe hypoxemia

    Time frame: 24 hours of treatment

    Time with saturation below 85%

  3. Time with hyperoxemia

    Time frame: 24 hours of treatment

    Time with saturation above 96%

Sponsors and collaborators

Lead sponsor

Hvidovre University Hospital

Other

Registry information

Official study title

Automatic Oxygen Supply With the O2matic Device for the Treatment of Hospitalized Heart Patients With Hypoxia

Acronym: O2matic-Card

Important dates

Study start
2022
Primary completion
2023
Study completion
2024
First posted
Jul 11, 2022
Registry last updated
Sep 19, 2024

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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