A Gray Zone Approach to Stroke Volume Variation Derived From NICOM

NCT01898975 | Withdrawn DMC

• 1 other identifier: 2013-03-053-001
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Stroke volume variation

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

  5min following the end of rapid fluid infusion

Secondary Outcomes (1)

• Correlation with pulse pressure variation

  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

Study Arms (1)

500ml fluid loading

All enrolled patients

Other: 500ml fluid loading

Interventions

500ml fluid loading OTHER

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

500ml fluid loading

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients undergoing neurosurgery under general anesthesia in supine position

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Samsung Medical Center: lead

Study Sites (1)

Samsung medical center

Seoul, 135-710, South Korea

Location

Study Officials

• Jong-Hwan Lee, MD, PhD

  Samsung Medical Center, Sungkyunkwan University School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: June 28, 2013
• First Posted: July 15, 2013
• Study Start: June 1, 2013
• Primary Completion: January 1, 2014
• Study Completion: May 1, 2014
• Last Updated: May 27, 2016

Record last verified: 2016-05

Locations

KR (1)