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Comparability of Invasive and Non-invasive Haemodynamic Monitoring (HMPR1)

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ClinicalTrials.gov Identifier: NCT02197858
Recruitment Status : Completed
First Posted : July 23, 2014
Last Update Posted : December 4, 2015
Sponsor:
Information provided by (Responsible Party):
Tino Münster, University of Erlangen-Nürnberg Medical School

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 .


Condition or disease
Anesthesia Anesthesia, Intravenous

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Study Type : Observational
Actual Enrollment : 40 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Clinical Comparison of Hemodynamic Parameters Using Invasive Versus Non-invasive Continuous Blood-pressure Technology During a Total Intravenous Anaesthesia (TIVA).
Study Start Date : July 2014
Actual Primary Completion Date : June 2015
Actual Study Completion Date : October 2015



Primary Outcome Measures :
  1. Mean arterial pressure [ Time Frame: during anesthesia induction ]

Secondary Outcome Measures :
  1. Cardiac output [ Time Frame: during anesthesia induction ]
  2. Stroke volume variation [ Time Frame: during anaesthesia induction ]
  3. Stroke volume [ Time Frame: during anesthesia induction ]
  4. Heart rate [ Time Frame: during anaesthesia induction ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients that get an elective surgery under general anesthesia
Criteria

Inclusion Criteria:

  • elective surgery with the necessity of an arterial catheter

Exclusion Criteria:

  • patient not consented
  • peripheral vascular disease

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02197858


Locations
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Germany
University Hospital
Erlangen, Bavaria, Germany, 91054
Sponsors and Collaborators
University of Erlangen-Nürnberg Medical School
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Responsible Party: Tino Münster, Prof. Dr., University of Erlangen-Nürnberg Medical School
ClinicalTrials.gov Identifier: NCT02197858    
Other Study ID Numbers: HMPR1
First Posted: July 23, 2014    Key Record Dates
Last Update Posted: December 4, 2015
Last Verified: December 2015
Keywords provided by Tino Münster, University of Erlangen-Nürnberg Medical School:
invasive arterial pressure
extended hemodynamic monitoring
propofol
remifentanil