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New Methods to Detect a Decrease in Heart Function

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ClinicalTrials.gov Identifier: NCT00192894
Recruitment Status : Completed
First Posted : September 19, 2005
Last Update Posted : September 19, 2005
Sponsor:
Collaborators:
The Danish Medical Research Council
Oberstinde Kirsten Jensa la Cours Foundation
Information provided by:
Rigshospitalet, Denmark

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
Orthopedic Surgery

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 Type : Observational
Enrollment : 32 participants
Observational Model: Defined Population
Observational Model: Natural History
Time Perspective: Cross-Sectional
Time Perspective: Prospective
Official Title: Cardiac Output Changes During Onset of Spinal Anesthesia in Elderly Patients
Study Start Date : May 2004
Study Completion Date : March 2005

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anesthesia





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Ages Eligible for Study:   60 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

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): NCT00192894


Locations
Denmark
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

ClinicalTrials.gov Identifier: NCT00192894     History of Changes
Other Study ID Numbers: 22-04-0019
First Posted: September 19, 2005    Key Record Dates
Last Update Posted: September 19, 2005
Last Verified: September 2005