Viewing Study NCT00192894



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Study NCT ID: NCT00192894
Status: COMPLETED
Last Update Posted: 2005-09-19
First Post: 2005-09-12

Brief Title: New Methods to Detect a Decrease in Heart Function
Sponsor: Rigshospitalet Denmark
Organization: Rigshospitalet Denmark

Study Overview

Official Title: Cardiac Output Changes During Onset of Spinal Anesthesia in Elderly Patients
Status: COMPLETED
Status Verified Date: 2005-09
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
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
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 Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None