A Gray Zone Approach to Stroke Volume Variation Derived F... | NCT01898975

Studies
A Gray Zone Approach to Stroke Volume Variation Derived From NICOM

NCT01898975

Sponsor

Samsung Medical Center

Status

Withdrawn

Last Update Posted

May 27, 2016Estimated

Enrollment

0Actual

Phase

Not provided

Conditions

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

Interventions

500ml fluid loading

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2016

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

The investigators decided not to proceed this study because of some internal matters.

Expanded Access Info

Start Date

Jun 2013

Primary Completion Date

Jan 2014Estimated

Completion Date

May 2014Estimated

First Submitted Date

Jun 28, 2013

First Submission Date that Met QC Criteria

Jul 10, 2013

First Posted Date

Jul 15, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 26, 2016

Last Update Posted Date

May 27, 2016Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Conditions Module

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

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
500ml fluid loading		All enrolled patients	Other: 500ml fluid loading

Interventions

Name	Type	Description	Arm Group Labels	Other Names
500ml fluid loading	Other	Fluid loading to evaluate fluid responsiveness	500ml fluid loading

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
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

Other Outcomes

Measure	Description	Time Frame
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

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Patients undergoing neurosurgery under general anesthesia in supine position

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Jong-Hwan Lee, MD, PhD	Samsung Medical Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Samsung medical center		Seoul		135-710	South Korea