O2matic Cardiology Protocol

Heart Diseases Clinical Trial

— O2matic-Card  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05452863
• Other study ID #: H-19033702
• Status: Recruiting
• Phase: N/A
• Start date: March 1, 2022
• Est. completion date: February 1, 2023

Study information

• Verified date: October 2022
• Source: Hvidovre University Hospital
• Contact: Jens D Hove, MD, PhD
• Phone: 38623218
• Email: jens.dahlgaard.hove[@]regionh.dk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: February 1, 2023
• Est. primary completion date: December 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Heart Diseases

Intervention

Device:
• O2matic administered oxygen
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
Oxygen supply is adjusted from manual measurements of the oxygen saturation

Locations

Country	Name	City	State
Denmark	Amager and Hvidovre Hospital University of Copenhagen	Copenhagen

Sponsors (1)

Lead Sponsor	Collaborator
Hvidovre University Hospital

Country where clinical trial is conducted

Denmark, 

References & Publications (3)

Hansen EF, Bech CS, Vestbo J, Andersen O, Kofod LM. Automatic oxygen titration with O2matic® 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. — View Citation

Hansen EF, Hove JD, Bech CS, Jensen JS, Kallemose T, Vestbo J. Automated oxygen control with O2matic(®) 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. — View Citation

Kofod LM, Westerdahl E, Kristensen MT, Brocki BC, Ringbæk 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). pii: 4820. doi: 10.3390/jcm10214820. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time in designated saturation interval	We have predefined an optimum saturation interval of 92-96% with a target of 93%	24 hours of treatment
Secondary	Time with hypoxemia	Time with saturation below 92% but above 85%	24 hours of treatment
Secondary	Time with severe hypoxemia	Time with saturation below 85%	24 hours of treatment
Secondary	Time with hyperoxemia	Time with saturation above 96%	24 hours of treatment

External Links

•   Description of the device