Evaluation of a Continuous Non-invasive Arterial Pressure Device in Comparison With Invasive Pressure Measurement During Out-of-hospital Emergency

The aim of the study is to evaluate the accuracy of continuous non-invasive AP monitoring (CNAP) compared to simultaneous IBP measurement in intensive care patients undergoing a transport in the ambulance car.

Since CNAP finger blood pressure is calibrated to NBP level, a systematic bias between IBP and CNAP as described by a recent FDA meta analysis [ ] is expected. The most important factor of CNAP system performance is its ability to accurately track blood pressure changes. Thus, the purpose of this investigation is to show that the bias between CNAP and IBP falls within the expected range and that blood pressure alterations are detected instantaneously.

The endpoints of the study are:

• The agreement of systolic, diastolic and mean CNAP and IBP readings determined on a beat-to-beat basis during:
• Takeover of the patient on the intensive care unit,
• Transport of the patient from the intensive care unit to the ambulance car
• Transport of the patient in the ambulance car
• The agreement of systolic, diastolic and mean CNAP and IBP blood pres-sure changes determined on a beat-to-beat basis during:
• Takeover of the patient on the intensive care unit,
• Transport of the patient from the intensive care unit to the ambulance car
• Transport of the patient in the ambulance car

The beat-to-beat readings of CNAP and IBP will be automatically recorded electronically on a memory card in the transport monitor. CNAP data will additionally be recorded directly on the CNAP Monitor with a memory stick. Safety will be assessed by clinical observations as well as adverse events (AE) recording.