A Gray Zone Approach to Stroke Volume Variation Derived From NICOM

Withdrawn

• Conditions: Gray Zone; Neurological Diseases or Conditions; Fluid Responsiveness; Non Invasive Cardiac Output Monitoring
• Interventions: Other: 500ml fluid loading

• Registration Number: NCT01898975
• Lead Sponsor: Samsung Medical Center

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2013-06
• Study First Submitted: 2013-06-28
• Study First Submitted QC: 2013-07-10
• Study First Posted: 2013-07-15
• Primary Completion: 2014-01
• Study Completion: 2014-05
• Status Verified: 2016-05
• Last Update Submitted: 2016-05-26
• Last Update Posted: 2016-05-27

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

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

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
500ml fluid loading	500ml fluid loading	All enrolled patients

Primary Outcome Measures

Name	Time	Method
Stroke volume variation	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 Outcome Measures

Name	Time	Method
Correlation with pulse pressure variation	5 min following the end of rapid fluid infusion	5min following the end of rapid fluid infusion: 5 min after the end of fluid loading

Trial Locations

Locations (1)

Samsung medical center; 🇰🇷 Seoul, Korea, Republic of