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

NCT ID: NCT02277353

Last Updated: 2015-07-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

40 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-10-31

Study Completion Date

2015-06-30

Brief Summary

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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

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Conditions

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Fluid Responsiveness Prone Position Non Invasive Cardiac Output Monitoring

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

Fluid loading to evaluate fluid responsiveness

Intervention Type OTHER

loading of hydroxyethyl starch 6ml/kg over 10-15min to all patients

Interventions

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Fluid loading to evaluate fluid responsiveness

loading of hydroxyethyl starch 6ml/kg over 10-15min to all patients

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Samsung Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Jong Hwan Lee

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jeong Jin Min, MD

Role: STUDY_DIRECTOR

Samsung Medical Center

Locations

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Samsung Seoul Hospital, Samsung Medical Center

Seoul, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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2014-05-090-003

Identifier Type: -

Identifier Source: org_study_id

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