An observational study in Blood Pressure, sponsored by Robert Hanss. Status unknown at 1 site in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2012-06-25.
Sponsored by Robert Hanss · Observational
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 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.
Arterial pressure (AP) is one of the most important physiological variables. Particularly in emergency medicine, AP needs to be monitored repeatedly or even better, continuously. This is usually done using an oscillometric pressure device (NIBP). A number of studies emphasise the importance of continuous AP monitoring as more than 20% of all hypotensive episodes may be missed by NIBP and another 20% are detected with delay. Prolonged hypotension precedes 56% of perioperative cardiac arrests and is associated with a significant increase of the 1-year mortality rate, indicating that NBP monitoring especially in patients with cardiovascular diseases might be insufficient independent from the clinical setting. Recently, a monitor for continuous non-invasive AP monitoring (CNAP™ Monitor 500) was introduced. It was shown that during procedures with high risk of hypotension NIBP missed significant more hypotensive episodes than CNAP. At the moment we have no evidence of the performance of CNAP in the preclinical emergency medicine. The evaluation against the gold standard of invasive pressure measurement in this study will help us to evaluate the performance of CNAP in the preclinical setting.
1,692 studies on the registry are indexed under Emergencies; 333 are open to participants now.
This study's planned enrollment of 40 is below the median of 353 across 714 observational studies indexed under Emergencies.
Browse Emergencies studies →This is the only study on the registry with Robert Hanss as lead sponsor.
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ICU Patients with established arterial pressure measurement
Exclusion Criteria:
Emergency Patients with applied arterial blood pressure measurement
Device: CNAP-Monitor
Continuous non-invasive arterial blood pressure recording
Also known as: CNAP, Continuous non-invasive arterial blood pressure recording
agreement with invasive blood pressure
beat-to-beat readings of CNAP and IBP
Time frame: 1 year
This study is status unknown, as verified in Jun 2012. You cannot join it, but the record below documents what was studied.
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