A Gray Zone Approach to Stroke Volume Variation Derived From NICOM

NCT ID: NCT01898975

Last Updated: 2016-05-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Study Classification

OBSERVATIONAL

Study Start Date

2013-06-30

Study Completion Date

2014-05-31

Brief Summary

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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

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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.

Conditions

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Neurological Diseases or Conditions Fluid Responsiveness Non Invasive Cardiac Output Monitoring Gray Zone

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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500ml fluid loading

All enrolled patients

500ml fluid loading

Intervention Type OTHER

Fluid loading to evaluate fluid responsiveness

Interventions

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500ml fluid loading

Fluid loading to evaluate fluid responsiveness

Intervention Type OTHER

Other Intervention Names

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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

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Samsung Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Jong Hwan Lee

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jong-Hwan Lee, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Samsung Medical Center, Sungkyunkwan University School of Medicine

Locations

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Samsung medical center

Seoul, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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2013-03-053-001

Identifier Type: -

Identifier Source: org_study_id

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