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WithdrawnNCT01898975Updated May 27, 2016

A Gray Zone Approach to Stroke Volume Variation Derived From NICOM

An observational study in Neurological Diseases or Conditions, Fluid Responsiveness and Non Invasive Cardiac Output Monitoring, sponsored by Samsung Medical Center. Withdrawn at 1 site in Korea, Republic of. Open to participants aged 20 Years to 80 Years. Per ClinicalTrials.gov, last updated 2016-05-27.

Sponsored by Samsung Medical Center · Observational

Why this study was withdrawn
The investigators decided not to proceed this study because of some internal matters.
Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
0
Ages
20 Years to 80 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

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

Keywords

  • Neurosurgical patients
  • Fluid loading
  • Fluid responsiveness
  • NICOM
  • Stroke volume variation
  • Pulse pressure variation
  • Total peripheral resistance
  • Gray zone approach
03

In context

Nervous System Diseases

974 studies on the registry are indexed under Nervous System Diseases; 252 are open to participants now.

Browse Nervous System Diseases studies →

Lead sponsor

Samsung Medical Center is the lead sponsor of 980 studies on the registry; 146 are open to participants now.

Of its 7 completed or terminated interventional studies of FDA-regulated products, 1 (14%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

Patients undergoing neurosurgery under general anesthesia in supine position

Inclusion criteria

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

Exclusion criteria

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
05

Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
0 participants (actual)
Patient registry
No

Groups and cohorts

  • 500ml fluid loading

    All enrolled patients

    Other: 500ml fluid loading

Interventions

  • Other500ml fluid loading

    Fluid loading to evaluate fluid responsiveness

    Also known as: 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

06

What researchers measure

Primary outcomes

  1. Stroke volume variation

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

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

Secondary outcomes

  1. Correlation with pulse pressure variation

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

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

Other outcomes

  1. 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

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

07

Study locations

1 site
  • Samsung medical center
    Seoul, 135-710, Korea, Republic of
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 27, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01898975
Lead sponsor
Samsung Medical Center
Responsible party
Jong Hwan Lee (Assistant Professor, Samsung Medical Center) — Principal investigator
First posted
Jul 15, 2013
Start date
Jun 2013
Primary completion
Jan 2014 (estimated)
Completion
May 2014 (estimated)
Last update
May 27, 2016

Study contacts

Jong-Hwan Lee, MD, PhD
principal investigator · Samsung Medical Center, Sungkyunkwan University School of Medicine

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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