Clinical trial NCT01898975: A Gray Zone Approach to Stroke Volume Variation Derived From NICOM
Official title: Evaluation of Stroke Volume Variation Derived From NICOM as a Predictor of Fluid Responsiveness in Neurosurgical Patients: A Gray Zone Approach
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
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
Lead sponsor: Samsung Medical Center
Sponsor class: OTHER
First posted: 2013-07-15
Enrollment: 0
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients undergoing neurosurgery under general anesthesia in supine position

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.

Eligibility criteria: 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

Primary outcomes:
measure: Stroke volume variation
timeFrame: 5min following the end of rapid fluid infusion
Secondary outcomes:
measure: Correlation with pulse pressure variation
timeFrame: 5 min following the end of rapid fluid infusion
Other outcomes:
measure: TPR(total peripheral resistance), TPRI(total peripheral resistance index)
timeFrame: 5min following the end of rapid fluid infusion
Locations:
city: Seoul
country: Korea, Republic of
facility: Samsung medical center
Study officials:
affiliation: Samsung Medical Center, Sungkyunkwan University School of Medicine
name: Jong-Hwan Lee, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: