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New Methods to Detect a Decrease in Heart Function

Sponsor
Rigshospitalet, Denmark (Other)
Overall Status
Completed
CT.gov ID
NCT00192894
Collaborator
The Danish Medical Research Council (Other), Oberstinde Kirsten Jensa la Cours Foundation (Other)
32
Enrollment
1
Location
10
Duration (Months)
3.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study was to evaluate the changes in heart function during onset of spinal anesthesia using a new and less invasive method, the LidcoTMplus.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    The incidence of hypotension during onset of spinal anesthesia in elderly patients varies from 27% to 80% depending on which definition being used. Studies of cardiac output (CO) has shown that it is maintained or only slightly decreased .

    Unfortunately, the time-resolution in these studies is often several minutes, and the description of changes is consequently often a start-to-end relation rather than a description of the dynamic changes during onset of spinal anesthesia.

    A recent advance in measuring CO is the LiDCOTMplus hemodynamic monitor, which has proved reliable compared to pulmonary artery catheters in various intensive care settings. This monitor allows for beat-to-beat measuring during various procedures and thus early warning of hemodynamic events.

    Another method with potential for early warning of decreased perfusion is near-infrared spectroscopy (NIRS). NIRS is used for continuous and non-invasive monitoring of cerebral oxygen saturation (ScO2) and even a small reduction has recently shown to predict maternal hypotension during caesarian section.

    The aim of our study was to describe the changes in CO during onset of spinal anesthesia in elderly patients using a method with high time-resolution. We also attempted to evaluate NIRS as predictor of hemodynamic events.

    Study Design

    Study Type:
    Observational
    Observational Model:
    Defined Population
    Time Perspective:
    Other
    Official Title:
    Cardiac Output Changes During Onset of Spinal Anesthesia in Elderly Patients
    Study Start Date :
    May 1, 2004
    Study Completion Date :
    Mar 1, 2005

    Outcome Measures

    Primary Outcome Measures

      Eligibility Criteria

      Criteria

      Ages Eligible for Study:
      60 Years and Older
      Sexes Eligible for Study:
      All
      Accepts Healthy Volunteers:
      No
      Inclusion Criteria:

      • Age 60 years or older

      • Elective orthopedic or plastic lower limp surgery

      • in spinal anesthesia

      Exclusion Criteria:

      • Body weight <40 kg

      • Currently in treatment with lithium

      • Evidence of aortic valve regurgitation

      Contacts and Locations

      Locations

      Site City State Country Postal Code
      1 Department of anaesthesia, 4231, Center of Head and Orthopaedics, Copenhagen University Hospital, Rigshospitalet Copenhagen Denmark 2100

      Sponsors and Collaborators

      • Rigshospitalet, Denmark
      • The Danish Medical Research Council
      • Oberstinde Kirsten Jensa la Cours Foundation

      Investigators

      • Study Chair: Lars S. Rasmussen, MD, PhD, Department of anaesthesia, 4231, Center of Head and Orthopaedics, Copenhagen University Hospital, Rigshospitalet

      Study Documents (Full-Text)

      None provided.

      More Information

      Publications

      None provided.
      Responsible Party:
      , ,
      ClinicalTrials.gov Identifier:
      NCT00192894
      Other Study ID Numbers:
      • 22-04-0019
      First Posted:
      Sep 19, 2005
      Last Update Posted:
      Sep 19, 2005
      Last Verified:
      Sep 1, 2005

      Study Results

      No Results Posted as of Sep 19, 2005