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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02277353
Other study ID # 2014-05-090-003
Secondary ID
Status Completed
Phase N/A
First received October 9, 2014
Last updated July 20, 2015
Start date October 2014
Est. completion date June 2015

Study information

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

Clinical Trial 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.


Recruitment information / eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective


Related Conditions & MeSH terms


Intervention

Other:
Fluid loading to evaluate fluid responsiveness
loading of hydroxyethyl starch 6ml/kg over 10-15min to all patients

Locations

Country Name City State
Korea, Republic of Samsung Seoul Hospital, Samsung Medical Center Seoul

Sponsors (1)

Lead Sponsor Collaborator
Samsung Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

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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Completed NCT05419570 - Short Time Low PEEP Challenge and Mini Fluid Challenge