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CNAP Accuracy Dependent on Hemodynamic Variables

Sponsor
University Hospital Schleswig-Holstein (Other)
Overall Status
Completed
CT.gov ID
NCT01743846
Collaborator
(none)
50
Enrollment
1
Location
17.9
Duration (Months)
2.8
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Agreement of CNAP pressure with invasive pressure is evaluated dependent on hemodynamic variables achieved by a PICCO monitor.

Hypothesis: Low cardiac output and volume status but not high vascular resistance affect the accuracy of CNAP.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    Agreement of CNAP pressure with invasive pressure is evaluated dependent on hemodynamic variables achieved by a PICCO monitor.

    Hypothesis: Low cardiac output and volume status but not high vascular resistance affect the accuracy of CNAP. Body mass index and age may have impact on the accuracy of PPV measured non-invasively on the basis of volume-clamp technique.

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    50 participants
    Observational Model:
    Case-Only
    Time Perspective:
    Prospective
    Official Title:
    Accuracy of Continuous Non-invasive Arterial Pressure (CNAP) With Invasive Measurements Dependent on Cardiac Function, Vascular Resistance and Volume Status
    Study Start Date :
    Jan 1, 2014
    Actual Primary Completion Date :
    Jul 1, 2015
    Actual Study Completion Date :
    Jul 1, 2015

    Arms and Interventions

    Arm Intervention/Treatment
    Major Surgery

    Patients undergoing major surgery

    Outcome Measures

    Primary Outcome Measures

    1. arterial pressure [intraoperative]

      Accuracy and precision of CNAP in comparison with the gold standard

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 99 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • need for invasive blood pressure measurement
    Exclusion Criteria:

    • age under 18

    • emergencies

    • cardiac dysrhythmia

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University Hospital, Schleswig-Holstein. Departement of Anaesthesia and Intensive Care Medicine Kiel Germany 24106

    Sponsors and Collaborators

    • University Hospital Schleswig-Holstein

    Investigators

    • Principal Investigator: Jochen Renner, PD Dr., University Hospital, Schleswig-Holstein. Departement of Anaesthesia and Intensive Care Medicine
    • Principal Investigator: Robert Hanss, Prof. Dr., University Hospital, Schleswig-Holstein. Departement of Anaesthesia and Intensive Care Medicine

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Dr. Jochen Renner, PD Dr. med Jochen Renner, University Hospital Schleswig-Holstein
    ClinicalTrials.gov Identifier:
    NCT01743846
    Other Study ID Numbers:
    • CNAP 2010_3
    First Posted:
    Dec 6, 2012
    Last Update Posted:
    Dec 8, 2015
    Last Verified:
    Dec 1, 2015

    Study Results

    No Results Posted as of Dec 8, 2015