O2matic Cardiology Protocol (O2matic-Card)

September 18, 2024 updated by: Jens D Hove, MD,PHD, Hvidovre University Hospital

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Copenhagen, Denmark, DK-2650
        • Amager and Hvidovre Hospital University of Copenhagen

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Automatic oxygen supply
Oxygen will be supplied by the O2matic device
Device: O2matic administered oxygen
Oxygen supply is adjusted from an almost continuous measurement of the oxygen saturation with an appropriate an previously tested algorithm.
Placebo Comparator: Manual oxygen supply
Oxygen will be supplied by nurse adjustments in the usual way
Device: Manual oxygen supply and adjustments
Oxygen supply is adjusted from manual measurements of the oxygen saturation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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%
24 hours of treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time with hypoxemia
Time Frame: 24 hours of treatment
Time with saturation below 92% but above 85%
24 hours of treatment
Time with severe hypoxemia
Time Frame: 24 hours of treatment
Time with saturation below 85%
24 hours of treatment
Time with hyperoxemia
Time Frame: 24 hours of treatment
Time with saturation above 96%
24 hours of treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hvidovre University Hospital

Investigators

  • Principal Investigator: Jens D Hove, MD, PhD, Amager-Hvidovre Universitetshospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2022

Primary Completion (Actual)

March 18, 2023

Study Completion (Actual)

March 18, 2024

Study Registration Dates

First Submitted

July 4, 2022

First Submitted That Met QC Criteria

July 8, 2022

First Posted (Actual)

July 11, 2022

Study Record Updates

Last Update Posted (Actual)

September 19, 2024

Last Update Submitted That Met QC Criteria

September 18, 2024

Last Verified

September 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H-19033702

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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