New Methods to Detect a Decrease in Heart Function

Orthopedic Surgery Clinical Trial

Official title:

Cardiac Output Changes During Onset of Spinal Anesthesia in Elderly Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00192894
• Other study ID #: 22-04-0019
• Status: Completed
• Phase: Phase 4
• First received: September 12, 2005
• Last updated: September 12, 2005
• Start date: May 2004
• Est. completion date: March 2005

Study information

• Verified date: September 2005
• Source: Rigshospitalet, Denmark
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: National Board of Health
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: March 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 60 Years and older

Eligibility

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

Study Design

Observational Model: Defined Population, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Orthopedic Surgery

Locations

Country	Name	City	State
Denmark	Department of anaesthesia, 4231, Center of Head and Orthopaedics, Copenhagen University Hospital, Rigshospitalet	Copenhagen

Sponsors (3)

Lead Sponsor	Collaborator
Rigshospitalet, Denmark	Oberstinde Kirsten Jensa la Cours Foundation, The Danish Medical Research Council

Country where clinical trial is conducted

Denmark,