O2matic Cardiology Protocol (O2matic-Card)

Hvidovre University Hospital

Status: Completed

Conditions: Heart Diseases

Treatments: Device: Manual oxygen supply and adjustments; Device: O2matic administered oxygen

Study type: Interventional

Funder types: Other

Identifiers

NCT05452863

H-19033702

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 patients

Sex: All

Ages: 30+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups, including a placebo group

Automatic oxygen supply

Active Comparator group

Description:

Oxygen will be supplied by the O2matic device

Treatment:

Device: O2matic administered oxygen

Manual oxygen supply

Placebo Comparator group

Description:

Oxygen will be supplied by nurse adjustments in the usual way

Treatment:

Device: Manual oxygen supply and adjustments