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

NCT02277353 | Completed DMC

• 1 other identifier: 2014-05-090-003
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Fluid Responsiveness; Prone Position; Non Invasive Cardiac Output Monitoring

Keywords

Fluid responsiveness; NICOM; Prone Position; Stroke Volume Variation

Outcome Measures

Primary Outcomes (1)

• Stroke volume variation from NICOM®

  predictability of stroke volume variation from NICOM® for fluid responsiveness

  5 min after infusion of bolus fluid

Secondary Outcomes (1)

• pulse pressure variation and stroke volume variation from Flotrac/Vigileo system

  5 min after infusion of bolus fluid

Other Outcomes (1)

• TPR (total peripheral resistance), TPRI (total peripheral resistance index)

  5 min after infusion of bolus fluid

Study Arms (1)

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

Interventions

Fluid loading to evaluate fluid responsiveness OTHER

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

All enrolled patients

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients undergoing spine surgery under general anesthesia in prone position

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Samsung Medical Center: lead

Study Sites (1)

Samsung Seoul Hospital, Samsung Medical Center

Seoul, 135-710, South Korea

Location

Study Officials

• Jeong Jin Min, MD

  Samsung Medical Center

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: October 9, 2014
• First Posted: October 29, 2014
• Study Start: October 1, 2014
• Primary Completion: June 1, 2015
• Study Completion: June 1, 2015
• Last Updated: July 21, 2015

Record last verified: 2015-07

Locations

KR (1)