O2matic Cardiology Protocol

NCT ID: NCT05452863

Last Updated: 2024-09-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-03-01

Study Completion Date

2024-03-18

Brief Summary

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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

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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.

Conditions

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Heart Diseases

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomized, open-label study
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Automatic oxygen supply

Oxygen will be supplied by the O2matic device

Group Type ACTIVE_COMPARATOR

O2matic administered oxygen

Intervention Type DEVICE

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

Manual oxygen supply

Oxygen will be supplied by nurse adjustments in the usual way

Group Type PLACEBO_COMPARATOR

Manual oxygen supply and adjustments

Intervention Type DEVICE

Oxygen supply is adjusted from manual measurements of the oxygen saturation

Interventions

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O2matic administered oxygen

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

Intervention Type DEVICE

Manual oxygen supply and adjustments

Oxygen supply is adjusted from manual measurements of the oxygen saturation

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

30 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hvidovre University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Jens D Hove, MD,PHD

Associate Professor, MD, PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jens D Hove, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Amager-Hvidovre Universitetshospital

Locations

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Amager and Hvidovre Hospital University of Copenhagen

Copenhagen, , Denmark

Site Status

Countries

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Denmark

References

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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.

Reference Type BACKGROUND
PMID: 33144929 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 34768338 (View on PubMed)

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.

Reference Type RESULT
PMID: 30587955 (View on PubMed)

Taraldsen IA, Grand J, Lukoschewitz JD, Seven E, Dixen U, Petersen M, Rytoft L, Jakobsen MM, Hansen EF, Hove JD. Automated oxygen administration versus manual control in acute cardiovascular care: a randomised controlled trial. Heart. 2024 Dec 13;111(1):27-34. doi: 10.1136/heartjnl-2024-324488.

Reference Type DERIVED
PMID: 39486892 (View on PubMed)

Taraldsen IA, Grand J, Lukoschewitz JD, Hansen EF, Hove JD. Automated versus manual oxygen administration for patients admitted with acute cardiovascular disease - a study protocol of a randomised controlled trial. Dan Med J. 2023 Mar 27;70(4):A12220784.

Reference Type DERIVED
PMID: 36999819 (View on PubMed)

Related Links

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https://o2matic.com

Description of the device

Other Identifiers

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H-19033702

Identifier Type: -

Identifier Source: org_study_id

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