Fluid Responsiveness Clinical Trial
Official title:
Evaluation of Stroke Volume Variation Derived From NICOM as a Predictor of Fluid Responsiveness in Prone Position During Spine Surgery
Verified date | July 2015 |
Source | Samsung Medical Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | South Korea: Institutional Review Board |
Study type | Observational |
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.
Status | Completed |
Enrollment | 40 |
Est. completion date | June 2015 |
Est. primary completion date | June 2015 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 20 Years to 80 Years |
Eligibility |
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 |
Observational Model: Cohort, Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
Korea, Republic of | Samsung Seoul Hospital, Samsung Medical Center | Seoul |
Lead Sponsor | Collaborator |
---|---|
Samsung Medical Center |
Korea, Republic of,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | TPR (total peripheral resistance), TPRI (total peripheral resistance index) | 5 min after infusion of bolus fluid | Yes | |
Primary | Stroke volume variation from NICOM® | predictability of stroke volume variation from NICOMĀ® for fluid responsiveness | 5 min after infusion of bolus fluid | Yes |
Secondary | pulse pressure variation and stroke volume variation from Flotrac/Vigileo system | Correlation with pulse pressure variation, stroke volume variation from Flotrac/Vigileo system | 5 min after infusion of bolus fluid | Yes |
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