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

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ClinicalTrials.gov Identifier: NCT02277353
Recruitment Status : Completed
First Posted : October 29, 2014
Last Update Posted : July 21, 2015
Sponsor:
Information provided by (Responsible Party):
Jong Hwan Lee, 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.

Condition or disease Intervention/treatment
Fluid Responsiveness Prone Position Non Invasive Cardiac Output Monitoring Other: Fluid loading to evaluate fluid responsiveness

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Study Type : Observational
Actual Enrollment : 40 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Evaluation of Stroke Volume Variation Derived From NICOM as a Predictor of Fluid Responsiveness in Prone Position During Spine Surgery
Study Start Date : October 2014
Actual Primary Completion Date : June 2015
Actual Study Completion Date : June 2015

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




Primary Outcome Measures :
  1. Stroke volume variation from NICOM® [ Time Frame: 5 min after infusion of bolus fluid ]
    predictability of stroke volume variation from NICOM® for fluid responsiveness


Secondary Outcome Measures :
  1. 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


Other Outcome Measures:
  1. TPR (total peripheral resistance), TPRI (total peripheral resistance index) [ Time Frame: 5 min after infusion of bolus fluid ]


Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients undergoing spine surgery under general anesthesia in prone position
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02277353


Locations
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Korea, Republic of
Samsung Seoul Hospital, Samsung Medical Center
Seoul, Korea, Republic of, 135-710
Sponsors and Collaborators
Samsung Medical Center
Investigators
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Study Director: Jeong Jin Min, MD Samsung Medical Center
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Responsible Party: Jong Hwan Lee, Assistant Professor, Samsung Medical Center
ClinicalTrials.gov Identifier: NCT02277353    
Other Study ID Numbers: 2014-05-090-003
First Posted: October 29, 2014    Key Record Dates
Last Update Posted: July 21, 2015
Last Verified: July 2015
Keywords provided by Jong Hwan Lee, Samsung Medical Center:
Fluid responsiveness
NICOM
Prone Position
Stroke Volume Variation