A Gray Zone Approach to Stroke Volume Variation Derived From NICOM

Fluid Responsiveness Clinical Trial

Official title:

Evaluation of Stroke Volume Variation Derived From NICOM as a Predictor of Fluid Responsiveness in Neurosurgical Patients: A Gray Zone Approach

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01898975
• Other study ID #: 2013-03-053-001
• Status: Withdrawn
• Phase: N/A
• First received: June 28, 2013
• Last updated: May 26, 2016
• Start date: June 2013
• Est. completion date: May 2014

Study information

• Verified date: May 2016
• Source: Samsung Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: South Korea: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: May 2014
• Est. primary completion date: January 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 80 Years

Eligibility

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

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

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

Intervention

Other:
• 500ml fluid loading
Fluid loading to evaluate fluid responsiveness

Locations

Country	Name	City	State
Korea, Republic of	Samsung medical center	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Samsung Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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	5min following the end of rapid fluid infusion	Yes
Primary	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	Yes
Secondary	Correlation with pulse pressure variation	5min following the end of rapid fluid infusion: 5 min after the end of fluid loading	5 min following the end of rapid fluid infusion	Yes