Ignite Creation Date:
2025-12-25 @ 1:46 AM
Ignite Modification Date:
2025-12-26 @ 12:05 AM
Study NCT ID:
NCT00192894
Status:
COMPLETED
Last Update Posted:
2025-04-04
First Post:
2005-09-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
New Methods to Detect a Decrease in Heart Function
Sponsor:
Rigshospitalet, Denmark
Organization:
Study Overview
Official Title:
Cardiac Output Changes During Onset of Spinal Anesthesia in Elderly Patients
Status:
COMPLETED
Status Verified Date:
2024-11
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.
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:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: