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Completed

NCT Number: NCT02277353

Evaluation of SVV 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.

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Key information

Conditions

Fluid Responsiveness Non Invasive Cardiac Output Monitoring Prone Position

Age range

20 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Samsung Seoul Hospital, Samsung Medical Center

Seoul, 135-710, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Fluid loading to evaluate fluid responsiveness

Other

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

Primary outcomes

  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 outcomes

  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 outcomes

  1. TPR (total peripheral resistance), TPRI (total peripheral resistance index)

    Time frame: 5 min after infusion of bolus fluid

Sponsors and collaborators

Lead sponsor

Samsung Medical Center

Other

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Oct 29, 2014
Registry last updated
Jul 21, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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