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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

Status
Withdrawn
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01898975
Enrollment
0
Registered
2013-07-15
Start date
2013-06-30
Completion date
2014-05-31
Last updated
2016-05-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

Neurosurgical patients, Fluid loading, Fluid responsiveness, NICOM, Stroke volume variation, Pulse pressure variation, Total peripheral resistance, Gray zone approach

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.

Interventions

OTHER500ml fluid loading

Fluid loading to evaluate fluid responsiveness

Sponsors

Samsung Medical Center
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
20 Years to 80 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Stroke volume variation5min following the end of rapid fluid infusion5min following the end of rapid fluid infusion: 5 min after the end of fluid loading

Secondary

MeasureTime frameDescription
Correlation with pulse pressure variation5 min following the end of rapid fluid infusion5min following the end of rapid fluid infusion: 5 min after the end of fluid loading

Other

MeasureTime frameDescription
TPR(total peripheral resistance), TPRI(total peripheral resistance index)5min following the end of rapid fluid infusion5min following the end of rapid fluid infusion: 5 min after the end of fluid loading

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026