Heart Diseases
Conditions
Keywords
hypoxemia, cardiology, automatic oxygen supply
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.
Interventions
DEVICEO2matic administered oxygen
Oxygen supply is adjusted from an almost continuous measurement of the oxygen saturation with an appropriate an previously tested algorithm.
DEVICEManual oxygen supply and adjustments
Oxygen supply is adjusted from manual measurements of the oxygen saturation
Sponsors
Hvidovre University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Randomized, open-label study
Eligibility
Sex/Gender
ALL
Age
30 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time in designated saturation interval | 24 hours of treatment | We have predefined an optimum saturation interval of 92-96% with a target of 93% |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time with hypoxemia | 24 hours of treatment | Time with saturation below 92% but above 85% |
| Time with severe hypoxemia | 24 hours of treatment | Time with saturation below 85% |
| Time with hyperoxemia | 24 hours of treatment | Time with saturation above 96% |
Countries
Denmark
Outcome results
None listed