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O2matic Cardiology Protocol (O2matic-Card)

Primary Purpose

Heart Diseases

Status
Recruiting
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
O2matic administered oxygen
Manual oxygen supply and adjustments
Sponsored by
Hvidovre University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Heart Diseases focused on measuring hypoxemia, cardiology, automatic oxygen supply

Eligibility Criteria

30 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Amager and Hvidovre Hospital University of CopenhagenRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Automatic oxygen supply

Manual oxygen supply

Arm Description

Oxygen will be supplied by the O2matic device

Oxygen will be supplied by nurse adjustments in the usual way

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Time with hypoxemia
Time with saturation below 92% but above 85%
Time with severe hypoxemia
Time with saturation below 85%
Time with hyperoxemia
Time with saturation above 96%

Full Information

First Posted
July 4, 2022
Last Updated
October 14, 2022
Sponsor
Hvidovre University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05452863
Brief Title
O2matic Cardiology Protocol
Acronym
O2matic-Card
Official Title
Automatic Oxygen Supply With the O2matic Device for the Treatment of Hospitalized Heart Patients With Hypoxia
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Recruiting
Study Start Date
March 1, 2022 (Actual)
Primary Completion Date
December 1, 2022 (Anticipated)
Study Completion Date
February 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hvidovre University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Diseases
Keywords
hypoxemia, cardiology, automatic oxygen supply

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized, open-label study
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Automatic oxygen supply
Arm Type
Active Comparator
Arm Description
Oxygen will be supplied by the O2matic device
Arm Title
Manual oxygen supply
Arm Type
Placebo Comparator
Arm Description
Oxygen will be supplied by nurse adjustments in the usual way
Intervention Type
Device
Intervention Name(s)
O2matic administered oxygen
Intervention Description
Oxygen supply is adjusted from an almost continuous measurement of the oxygen saturation with an appropriate an previously tested algorithm.
Intervention Type
Device
Intervention Name(s)
Manual oxygen supply and adjustments
Intervention Description
Oxygen supply is adjusted from manual measurements of the oxygen saturation
Primary Outcome Measure Information:
Title
Time in designated saturation interval
Description
We have predefined an optimum saturation interval of 92-96% with a target of 93%
Time Frame
24 hours of treatment
Secondary Outcome Measure Information:
Title
Time with hypoxemia
Description
Time with saturation below 92% but above 85%
Time Frame
24 hours of treatment
Title
Time with severe hypoxemia
Description
Time with saturation below 85%
Time Frame
24 hours of treatment
Title
Time with hyperoxemia
Description
Time with saturation above 96%
Time Frame
24 hours of treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jens D Hove, MD, PhD
Phone
38623218
Email
jens.dahlgaard.hove@regionh.dk
First Name & Middle Initial & Last Name or Official Title & Degree
Johannes Grand, MD, PhD
Email
johannes.grand@regionh.dk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jens D Hove, MD, PhD
Organizational Affiliation
Amager-Hvidovre Universitetshospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Amager and Hvidovre Hospital University of Copenhagen
City
Copenhagen
ZIP/Postal Code
DK-2650
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jens D Hove, MD, PhD
Phone
38623218
Email
jens.dahlgaard.hove@regionh.dk
First Name & Middle Initial & Last Name & Degree
Johannes Grand, MD, PhD
Email
johannes.grand@regionh.dk

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
33144929
Citation
Hansen EF, Bech CS, Vestbo J, Andersen O, Kofod LM. Automatic oxygen titration with O2matic(R) to patients admitted with COVID-19 and hypoxemic respiratory failure. Eur Clin Respir J. 2020 Oct 14;7(1):1833695. doi: 10.1080/20018525.2020.1833695.
Results Reference
background
PubMed Identifier
34768338
Citation
Kofod LM, Westerdahl E, Kristensen MT, Brocki BC, Ringbaek T, Hansen EF. Effect of Automated Oxygen Titration during Walking on Dyspnea and Endurance in Chronic Hypoxemic Patients with COPD: A Randomized Crossover Trial. J Clin Med. 2021 Oct 20;10(21):4820. doi: 10.3390/jcm10214820.
Results Reference
background
PubMed Identifier
30587955
Citation
Hansen EF, Hove JD, Bech CS, Jensen JS, Kallemose T, Vestbo J. Automated oxygen control with O2matic(R) during admission with exacerbation of COPD. Int J Chron Obstruct Pulmon Dis. 2018 Dec 14;13:3997-4003. doi: 10.2147/COPD.S183762. eCollection 2018.
Results Reference
result
Links:
URL
https://o2matic.com
Description
Description of the device

Learn more about this trial

O2matic Cardiology Protocol

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