O2matic Cardiology Protocol

Study Overview
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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.

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

Conditions
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Heart Diseases

Intervention / Treatment
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* Device: O2matic administered oxygen
* Device: Manual oxygen supply and adjustments


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 30 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized, open-label study
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Automatic oxygen supply<br>Oxygen will be supplied by the O2matic device | Device: O2matic administered oxygen<br>* Oxygen supply is adjusted from an almost continuous measurement of the oxygen saturation with an appropriate an previously tested algorithm.<br>|
| Placebo Comparator: Manual oxygen supply<br>Oxygen will be supplied by nurse adjustments in the usual way | Device: Manual oxygen supply and adjustments<br>* Oxygen supply is adjusted from manual measurements of the oxygen saturation<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time with hypoxemia | Time with saturation below 92% but above 85% | 24 hours of treatment | 
| Time with severe hypoxemia | Time with saturation below 85% | 24 hours of treatment | 
| Time with hyperoxemia | Time with saturation above 96% | 24 hours of treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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hypoxemia, cardiology, automatic oxygen supply