Comparability of Invasive and Non-invasive Haemodynamic Monitoring

Anesthesia Clinical Trial

— HMPR1  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02197858
• Other study ID #: HMPR1
• Status: Completed
• Phase: N/A
• First received: July 22, 2014
• Last updated: December 3, 2015
• Start date: July 2014
• Est. completion date: October 2015

Study information

• Verified date: December 2015
• Source: University of Erlangen-Nürnberg Medical School
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Observational

Clinical Trial 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 .

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: October 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• elective surgery with the necessity of an arterial catheter

Exclusion Criteria:

• patient not consented

• peripheral vascular disease

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Anesthesia
• Anesthesia, Intravenous

Locations

Country	Name	City	State
Germany	University Hospital	Erlangen	Bavaria

Sponsors (1)

Lead Sponsor	Collaborator
University of Erlangen-Nürnberg Medical School

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean arterial pressure		during anesthesia induction	No
Secondary	Cardiac output		during anesthesia induction	No
Secondary	Stroke volume variation		during anaesthesia induction	No
Secondary	Stroke volume		during anesthesia induction	No
Secondary	Heart rate		during anaesthesia induction	No