New Methods to Detect a Decrease in Heart Function

This study has been completed.
Sponsor:
Collaborators:
The Danish Medical Research Council
Oberstinde Kirsten Jensa la Cours fund
Information provided by:
Rigshospitalet, Denmark
ClinicalTrials.gov Identifier:
NCT00192894
First received: September 12, 2005
Last updated: NA
Last verified: September 2005
History: No changes posted
  Purpose

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 Phase
Orthopedic Surgery
Phase 4

Study Type: Observational
Study Design: Observational Model: Defined Population
Time Perspective: Cross-Sectional
Official Title: Cardiac Output Changes During Onset of Spinal Anesthesia in Elderly Patients

Further study details as provided by Rigshospitalet, Denmark:

Estimated Enrollment: 32
Study Start Date: May 2004
Estimated Study Completion Date: March 2005
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.

  Eligibility

Ages Eligible for Study:   60 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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 fund
Investigators
Study Chair: Lars S. Rasmussen, MD, PhD Department of anaesthesia, 4231, Center of Head and Orthopaedics, Copenhagen University Hospital, Rigshospitalet
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00192894     History of Changes
Other Study ID Numbers: 22-04-0019
Study First Received: September 12, 2005
Last Updated: September 12, 2005
Health Authority: Denmark: National Board of Health

ClinicalTrials.gov processed this record on April 22, 2014