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NCT02277353 Clinical Trial

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

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

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 NICOM® 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
See also
  Status Clinical Trial Phase
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Terminated NCT03208023 - RESIPI for Reducing Perioperative Major Adverse Cardiac Events N/A
Completed NCT03713008 - Assessment Of Carotid Flow During General Anesthesia N/A
Not yet recruiting NCT04092036 - Optic Nerve Sheath Diameter in Prediction of Fluid Responsiveness
Completed NCT04060069 - Pneumoperitoneum and Trendelenburg Position on Fluid Responsiveness
Recruiting NCT05153837 - Effect of Oral Water in Healthy Volunteers on Cardiac Output, Regional Flow and Microcirculation in Healthy Volunteers N/A
Not yet recruiting NCT06143111 - A Comparison of Thoracic Electrical Bioimpedance and FloTrac/Vigileo N/A
Not yet recruiting NCT05601622 - RPVI for Fluid Responsiveness in Children N/A
Completed NCT04889807 - Study of End Tidal Carbon Dioxide (EtCO2) Variation After an End- Expiratory Occlusion Test as a Predictive Criteria of Fluid Responsiveness in Mechanically Ventilated Patients
Recruiting NCT04186416 - Effectiveness of the Pressure Recording Analytical Method in Predicting Fluid Responsiveness in Pediatric Critical Care Patients
Completed NCT01996956 - Prediction of Fluid Responsiveness by NICOM (Non-invasive Cardiac Output Monitoring) in Children With Congenital Heart Disease After Cardiac Surgery N/A
Enrolling by invitation NCT04388995 - SVV and PPV Predict Fluid Responsiveness in Mechanically Ventilated Elderly Patients Under General Anesthesia N/A
Not yet recruiting NCT04574011 - Fluid Responsiveness in Spontaneously Ventilating Patient N/A
Completed NCT01821742 - Echocardiography in Kids Intensive Care Decision Support
Completed NCT04802668 - Factors Influencing of Pulse Pressure Variation (PPV)
Not yet recruiting NCT06254456 - Fluid Responsiveness in Prone Patients N/A
Completed NCT02789124 - Diagnostic Value of Passive Leg Raise Induced Changes in Carotid Artery Flow Time to Predict Fluid Responsiveness in Critically Ill Patients N/A
Withdrawn NCT01898975 - A Gray Zone Approach to Stroke Volume Variation Derived From NICOM N/A
Completed NCT02040948 - Accuracy of Pulse Pressure Variation and of Pleth Variability Index to Predict the Response to a Fluid Challenge N/A
Completed NCT05419570 - Short Time Low PEEP Challenge and Mini Fluid Challenge