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Clinical Trials/NCT01898975
NCT01898975
Withdrawn
Not Applicable

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

Samsung Medical Center1 site in 1 countryJune 2013

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Neurological Diseases or Conditions
Sponsor
Samsung Medical Center
Locations
1
Primary Endpoint
Stroke volume variation
Status
Withdrawn
Last Updated
9 years ago

Overview

Brief Summary

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.

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.

Registry
clinicaltrials.gov
Start Date
June 2013
End Date
May 2014
Last Updated
9 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Jong Hwan Lee

Assistant Professor

Samsung Medical Center

Eligibility Criteria

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

Outcomes

Primary Outcomes

Stroke volume variation

Time Frame: 5min following the end of rapid fluid infusion

5min following the end of rapid fluid infusion: 5 min after the end of fluid loading

Secondary Outcomes

  • Correlation with pulse pressure variation(5 min following the end of rapid fluid infusion)

Study Sites (1)

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