A Gray Zone Approach to Stroke Volume Variation Derived From NICOM

Evaluation of Stroke Volume Variation Derived From NICOM as a Predictor of Fluid Responsiveness in Neurosurgical Patients: A Gray Zone Approach

Optimal fluid management has been considered as crucial part to determine postoperative outcome and organ function. Recently developed, non invasive cardiac output measurement(NICOM, Cheetah Medical, Portland, OR)has enabled continuous cardiac output(CO) monitoring just by attaching electrode on chest wall. Moreover, CO and SSV derived from NICOM have been demonstrated as predictors of fluid responsiveness. Therefore, the aim of this study is to evaluate stroke volume variation derived from NICOM as a predictor of fluid responsiveness in neurosurgical patients. In addition, we plan to reveal inconclusive patients using gray zone approach.

Study Overview

• Status: Withdrawn
• Conditions: Fluid Responsiveness; Neurological Diseases or Conditions; Non Invasive Cardiac Output Monitoring; Gray Zone
• Intervention / Treatment: Other: 500ml fluid loading

Detailed Description

Optimal fluid management has been considered as crucial part to determine postoperative outcome and organ function. Many reports have focussed on evaluation of fluid responsiveness using various parameters such as pulse pressure variation (PPV) or stroke volume variation (SSV) derived from invasive or semi-invasive monitoring. Recently developed, non invasive cardiac output measurement(NICOM, Cheetah Medical, Portland, OR)has enabled continuous cardiac output(CO) monitoring just by attaching electrode on thorax. Moreover, CO and SSV derived from NICOM have been demonstrated as predictors of fluid responsiveness. Therefore, the aim of this study is to evaluate stroke volume variation derived from NICOM as a predictor of fluid responsiveness in neurosurgical patients. In addition, we plan to reveal inconclusive patients using gray zone approach.

• Study Type: Observational

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 135-710
    • Samsung Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Patients undergoing neurosurgery under general anesthesia in supine position

Description

Inclusion Criteria:

• ASA I or ASA II patients aged 20-80 undergoing neurosurgery in supine position

Exclusion Criteria:

• Pre-existing arrythmic disorders
• Congestive heart failure required medical treatment
• Preoperative Creatinine 1.3mg/dl
• observing self respiration during the study interventions
• Bleeding tendency
• Severe brain edema

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
500ml fluid loading; All enrolled patients	Other: 500ml fluid loading; Fluid loading to evaluate fluid responsiveness; Other Names: 500ml loading of crystalloid(Plasma Solution-A Injection CJ) over 15min; at the end of operation, when the main procedure finished and there is no strong; stimulation with stable hemodynamics

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Stroke volume variation	5min following the end of rapid fluid infusion: 5 min after the end of fluid loading	5min following the end of rapid fluid infusion

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Correlation with pulse pressure variation	5min following the end of rapid fluid infusion: 5 min after the end of fluid loading	5 min following the end of rapid fluid infusion

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
TPR(total peripheral resistance), TPRI(total peripheral resistance index)	5min following the end of rapid fluid infusion: 5 min after the end of fluid loading	5min following the end of rapid fluid infusion

Collaborators and Investigators

• Sponsor: Samsung Medical Center
• Investigators: Principal Investigator: Jong-Hwan Lee, MD, PhD, Samsung Medical Center, Sungkyunkwan University School of Medicine

Study record dates

Study Major Dates

• Study Start: June 1, 2013
• Primary Completion (Anticipated): January 1, 2014
• Study Completion (Anticipated): May 1, 2014

Study Registration Dates

• First Submitted: June 28, 2013
• First Submitted That Met QC Criteria: July 10, 2013
• First Posted (Estimate): July 15, 2013

Study Record Updates

• Last Update Posted (Estimate): May 27, 2016
• Last Update Submitted That Met QC Criteria: May 26, 2016
• Last Verified: May 1, 2016

More Information

Terms related to this study

• Keywords: Fluid responsiveness; Pulse pressure variation; Stroke volume variation; NICOM; Fluid loading; Neurosurgical patients; Total peripheral resistance; Gray zone approach
• Additional Relevant MeSH Terms: Nervous System Diseases
• Other Study ID Numbers: 2013-03-053-001