Comparability of Invasive and Non-invasive Haemodynamic Monitoring

NCT02197858 | Completed

• 1 other identifier: HMPR1
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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

Anesthesia; Anesthesia, Intravenous

Keywords

invasive arterial pressure; extended hemodynamic monitoring; propofol; remifentanil

Outcome Measures

Primary Outcomes (1)

• Mean arterial pressure

  during anesthesia induction

Secondary Outcomes (4)

• Cardiac output

  during anesthesia induction

• Stroke volume variation

  during anaesthesia induction

• Stroke volume

  during anesthesia induction

• Heart rate

  during anaesthesia induction

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients that get an elective surgery under general anesthesia

You may qualify if:

• elective surgery with the necessity of an arterial catheter

You may not qualify if:

• patient not consented
• peripheral vascular disease

Sponsors & Collaborators

• University of Erlangen-Nürnberg Medical School: lead

Study Sites (1)

University Hospital

Erlangen, Bavaria, 91054, Germany

Location

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr.

Study Record Dates

• First Submitted: July 22, 2014
• First Posted: July 23, 2014
• Study Start: July 1, 2014
• Primary Completion: June 1, 2015
• Study Completion: October 1, 2015
• Last Updated: December 4, 2015

Record last verified: 2015-12

Locations

DE (1)