Evaluation of SVV From NICOM as a Predictor of Fluid Responsiveness in Prone Position During Spine Surgery

July 20, 2015 updated by: Jong Hwan Lee, Samsung Medical Center

Evaluation of Stroke Volume Variation Derived From NICOM as a Predictor of Fluid Responsiveness in Prone Position During Spine Surgery

NICOM® is a recently developed noninvasive cardiac output monitoring device, and indices derived from NICOM® such as SVV has been reported to predict fluid responsiveness in the previous studies. However, its usefulness in prone positioning has not been investigated. Thus, the aim of this prospective observational study is to evaluate the usefulness of stroke volume variation (SVV) derived from NICOM® to predict fluid responsiveness in prone patients undergoing spine surgery.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

40

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of, 135-710
        • Samsung Seoul Hospital, Samsung Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 76 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients undergoing spine surgery under general anesthesia in prone position

Description

Inclusion Criteria:

  • ASA I or II patients undergoing spine surgery in prone position

Exclusion Criteria:

  • Pre-existing arrhythmic disorders/moderate to severe valvular heart disease/obstructive pulmonary disease (COPD grade >2), left ventricular dysfunction with LV EF less than 50, preoperative need for inotropics or vasopressors
  • BMI >30kg/m^2 or <15kg/m^2
  • Preoperative serum Cr > 1.3mg/dL
  • Patients with coagulopathy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
All enrolled patients
This study enrolls patients undergoing elective spine surgery in prone position and all enrolled subjects may receive fluid loading with hemodynamic monitoring by Flotrac/Vigileo and NICOM, but the investigator does not assign specific interventions to the subjects of the study because this is a prospective observational study.
Other: Fluid loading to evaluate fluid responsiveness
loading of hydroxyethyl starch 6ml/kg over 10-15min to all patients

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Stroke volume variation from NICOM®
Time Frame: 5 min after infusion of bolus fluid
predictability of stroke volume variation from NICOM® for fluid responsiveness
5 min after infusion of bolus fluid

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
pulse pressure variation and stroke volume variation from Flotrac/Vigileo system
Time Frame: 5 min after infusion of bolus fluid
Correlation with pulse pressure variation, stroke volume variation from Flotrac/Vigileo system
5 min after infusion of bolus fluid

Other Outcome Measures

Outcome Measure
Time Frame
TPR (total peripheral resistance), TPRI (total peripheral resistance index)
Time Frame: 5 min after infusion of bolus fluid
5 min after infusion of bolus fluid

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Samsung Medical Center

Investigators

  • Study Director: Jeong Jin Min, MD, Samsung Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2014

Primary Completion (Actual)

June 1, 2015

Study Completion (Actual)

June 1, 2015

Study Registration Dates

First Submitted

October 9, 2014

First Submitted That Met QC Criteria

October 26, 2014

First Posted (Estimate)

October 29, 2014

Study Record Updates

Last Update Posted (Estimate)

July 21, 2015

Last Update Submitted That Met QC Criteria

July 20, 2015

Last Verified

July 1, 2015

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 2014-05-090-003

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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