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HMPR1: Comparability of Invasive and Non-invasive Haemodynamic Monitoring

Sponsor
University of Erlangen-Nürnberg Medical School (Other)
Overall Status
Completed
CT.gov ID
NCT02197858
Collaborator
(none)
40
Enrollment
1
Location
15
Duration (Months)
2.7
Patients Per Site Per Month

Study Details

Study Description

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 Intervention/Treatment Phase

    Study Design

    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 :
    Jul 1, 2014
    Actual Primary Completion Date :
    Jun 1, 2015
    Actual Study Completion Date :
    Oct 1, 2015

    Outcome Measures

    Primary Outcome Measures

    1. Mean arterial pressure [during anesthesia induction]

    Secondary Outcome Measures

    1. Cardiac output [during anesthesia induction]

    2. Stroke volume variation [during anaesthesia induction]

    3. Stroke volume [during anesthesia induction]

    4. Heart rate [during anaesthesia induction]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • elective surgery with the necessity of an arterial catheter
    Exclusion Criteria:

    • patient not consented

    • peripheral vascular disease

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University Hospital Erlangen Bavaria Germany 91054

    Sponsors and Collaborators

    • University of Erlangen-Nürnberg Medical School

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Tino Münster, Prof. Dr., University of Erlangen-Nürnberg Medical School
    ClinicalTrials.gov Identifier:
    NCT02197858
    Other Study ID Numbers:
    • HMPR1
    First Posted:
    Jul 23, 2014
    Last Update Posted:
    Dec 4, 2015
    Last Verified:
    Dec 1, 2015
    Keywords provided by Tino Münster, Prof. Dr., University of Erlangen-Nürnberg Medical School
    invasive arterial pressure
    extended hemodynamic monitoring
    propofol
    remifentanil

    Study Results

    No Results Posted as of Dec 4, 2015