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

Completed

• Conditions: Fluid Responsiveness; Non Invasive Cardiac Output Monitoring; Prone Position
• Interventions: Other: Fluid loading to evaluate fluid responsiveness

• Registration Number: NCT02277353
• Lead Sponsor: Samsung Medical Center

Brief Summary

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2014-10
• Study First Submitted: 2014-10-09
• Study First Submitted QC: 2014-10-26
• Study First Posted: 2014-10-29
• Primary Completion: 2015-06
• Study Completion: 2015-06
• Status Verified: 2015-07
• Last Update Submitted: 2015-07-20
• Last Update Posted: 2015-07-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

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

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
All enrolled patients	Fluid loading to evaluate fluid responsiveness	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.

Primary Outcome Measures

Name	Time	Method
Stroke volume variation from NICOM®	5 min after infusion of bolus fluid	predictability of stroke volume variation from NICOM® for fluid responsiveness

Secondary Outcome Measures

Name	Time	Method
pulse pressure variation and stroke volume variation from Flotrac/Vigileo system	5 min after infusion of bolus fluid	Correlation with pulse pressure variation, stroke volume variation from Flotrac/Vigileo system

Trial Locations

Locations (1)

Samsung Seoul Hospital, Samsung Medical Center; 🇰🇷 Seoul, Korea, Republic of