Changes of Right and Left Cerebral Oxygen Saturation and... | NCT01101490

Studies
Changes of Right and Left Cerebral Oxygen Saturation and Blood Flow During Nephrectomy in Lateral Decubitus Position

NCT01101490

Sponsor

Yonsei University

Status

Completed

Last Update Posted

Apr 22, 2011Estimated

Enrollment

20Actual

Phase

Not provided

Conditions

Nephrectomy

Interventions

Not provided

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

Apr 2011

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2010

Primary Completion Date

Jan 2011Actual

Completion Date

Jan 2011Actual

First Submitted Date

Apr 8, 2010

First Submission Date that Met QC Criteria

Apr 9, 2010

First Posted Date

Apr 12, 2010Estimated

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

Apr 21, 2011

Last Update Posted Date

Apr 22, 2011Estimated

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

The purpose of this study is to determine changes of right and left cerebral oxygen saturation and blood flow during nephrectomy in lateral decubitus position.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

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

20Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
brain oximeter saturation(%)		1 hour after operation
blood flow		1 hour after operation
velocity of superficial temporal artery in right and left side		1 hour after operation

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Adult patients (ASA physical status I and II) aged between 20-65 yrs

Exclusion Criteria:

Cardiovascular, renal, hepatic disease, or communication failure

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

the patients who visit Severance hospital for nephrectomy

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Jeong-Yeon Hong	Department of Anesthesiology and Pain Medicine, Yonsei University College of Medicine, Seoul, Korea	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Severance Hospital, Department of Anesthesiology & Pain Medicine		Seoul		120-752	South Korea