Clinical trial NCT05452863: O2matic Cardiology Protocol
Official title: Automatic Oxygen Supply With the O2matic Device for the Treatment of Hospitalized Heart Patients With Hypoxia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Heart Diseases
Keywords: hypoxemia
cardiology
automatic oxygen supply
Lead sponsor: Hvidovre University Hospital
Sponsor class: OTHER
First posted: 2022-07-11
Enrollment: 60
Sex: ALL
Minimum age (years): 30
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized, open-label study
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Time in designated saturation interval
timeFrame: 24 hours of treatment
Secondary outcomes:
measure: Time with hypoxemia
timeFrame: 24 hours of treatment
measure: Time with severe hypoxemia
timeFrame: 24 hours of treatment
measure: Time with hyperoxemia
timeFrame: 24 hours of treatment
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Amager and Hvidovre Hospital University of Copenhagen
Study officials:
affiliation: Amager-Hvidovre Universitetshospital
name: Jens D Hove, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.