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Accuracy of CNAP PPV Under General Anaesthesia

Sponsor
University Hospital Schleswig-Holstein (Other)
Overall Status
Completed
CT.gov ID
NCT02166580
Collaborator
(none)
54
Enrollment
1
Location
17.9
Duration (Months)
3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Noninvasive pulse pressure variation for the guidance of perioperative fluid therapy is compared with the gold standard of invasive measurements. Cardiac output is derived by the PICCO monitor.

Hypothesis: Noninvasive CNAP PPV predicts fluid responsiveness. A grey zone for the prediction of fluid responsiveness will be defined.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    Accuracy of PPV measured by two devices,PICCO and CNAP, is compared with the manually calculated PPV from the arterial line waveform. Established tests like passive leg raising and end-expiratory occlusion are used for prediction of fluid responsiveness. Intraoperative events like volume challenge are monitored.

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    54 participants
    Observational Model:
    Case-Control
    Time Perspective:
    Prospective
    Official Title:
    Comparison of the Non-invasive CNAP Pulse Pressure Variation With the Invasive Gold Standard
    Study Start Date :
    Jan 1, 2014
    Actual Primary Completion Date :
    Jul 1, 2015
    Actual Study Completion Date :
    Jul 1, 2015

    Outcome Measures

    Primary Outcome Measures

    1. Cardiac output [1, 2, 5, 10, 15 and 20 minutes after volume challange and]

      Improvement of cardiac output dependent on PPV before volume challenge

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 99 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • major surgery

    • need for invasive arterial measurements

    Exclusion Criteria:

    • age under 18

    • cardiac dysrhythmia

    • vascular pathology at punction site

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University Hospital, Schleswig-Holstein. Departement of Anaesthesiology 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:
    NCT02166580
    Other Study ID Numbers:
    • CNAP 2012_2
    First Posted:
    Jun 18, 2014
    Last Update Posted:
    Jun 6, 2017
    Last Verified:
    Jun 1, 2017

    Study Results

    No Results Posted as of Jun 6, 2017