Clinical Trials Directory

Trials / Completed

CompletedNCT02197858

Comparability of Invasive and Non-invasive Haemodynamic Monitoring

Clinical Comparison of Hemodynamic Parameters Using Invasive Versus Non-invasive Continuous Blood-pressure Technology During a Total Intravenous Anaesthesia (TIVA).

Status
Completed
Phase
Study type
Observational
Enrollment
40 (actual)
Sponsor
University of Erlangen-Nürnberg Medical School · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

Summary

During general anesthesia the basic non-invasive monitoring of hemodynamic parameters (blood pressure, O2-saturation, cardiogram) is crucial. It can be enhanced to so called "extended hemodynamic monitoring" depending on the operation and patient. Frequently an invasive arterial cannula is used to provide continuous information on the blood pressure. This invasive method is very accurate and clinically established, but can be linked to adverse effects e.g. reduction of the circulation flow distal of the canulla, haematoma, infection etc. ccNexfin (Edwards Lifescience) is a finger cuff measuring the blood pressure in a non-invasive manner. It thus offers beat-to-beat information even about the extended hemodynamic parameters as cardiac output (CO), cardiac index (CI), stroke volume (SV), stroke volume index (SVI) and stroke volume variation (SSV), if connected to the clinical platform EV1000 (Edwards Lifescience). Assuming that the two methods are equal we plan to measure extended hemodynamic parameters before, during induction and during ongoing anesthesia both invasive and non-invasive. Data will be recorded every 30sec. Clinical evaluation of the ccNexfin technology in respect to extended hemodynamic parameters is to our knowledge rare and further assessment in this field is needed to offer patients a potentially equally reliable but less invasive monitoring. Furthermore the study should model the effect of remifentanil, propofol or its combination on haemodynamics .

Conditions

Timeline

Start date
2014-07-01
Primary completion
2015-06-01
Completion
2015-10-01
First posted
2014-07-23
Last updated
2015-12-04

Locations

1 site across 1 country: Germany

Source: ClinicalTrials.gov record NCT02197858. Inclusion in this directory is not an endorsement.