Continous Assessment of Cerebral Autoregulation With Near... | NCT02959008

Studies
Continous Assessment of Cerebral Autoregulation With Near-infrared Spectroscopy

NCT02959008

Sponsor

Yu Liyun

Status

Unknown status

Last Update Posted

Nov 16, 2016Estimated

Enrollment

40Estimated

Phase

Not provided

Conditions

Cerebral Blood Flow
Cerebral Perfusion Pressure

Interventions

measure TOI and BP

Countries

Not provided

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

Nov 2016

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 2016

Primary Completion Date

Dec 2018Estimated

Completion Date

Dec 2019Estimated

First Submitted Date

Nov 5, 2016

First Submission Date that Met QC Criteria

Nov 5, 2016

First Posted Date

Nov 8, 2016Estimated

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

Nov 15, 2016

Last Update Posted Date

Nov 16, 2016Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

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

Cerebral autoregulation can be explained by a tight coupling between oxygen supply and demand of the brain, and is essential to maintain a constant cerebral blood flow (CBF) in the context of changes in cerebral perfusion pressure. In this study, investigators use Near-infrared spectroscopy (NIRS) to monitor cerebral autoregulation.

Detailed Description

Near-infrared spectroscopy (NIRS) is a noninvasive technology that real-time monitors cerebral tissue oxygenation index (TOI). Investigators use Near-infrared spectroscopy (NIRS) to monitor cerebral autoregulation of hypertensive participants and non-hypertensive participants.

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

40Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
normal		Human without hypertension, diabetes, anemia, liver disease and kidney disease. The group will measure TOI and BP.	Device: measure TOI and BP
hypertension		Human only have hypertension, without diabetes, anemia, liver disease and kidney disease. Hypertension group will measure TOI and BP.	Device: measure TOI and BP

Interventions

Name	Type	Description	Arm Group Labels	Other Names
measure TOI and BP	Device	Both groups measure TOI and BP.	hypertension normal

Measure	Description	Time Frame
range of cerebral autoregulation		30min

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

health people, or people with hypertension

Exclusion Criteria:

diabetes, anemia, liver disease, kidney disease.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

adult
health people
people with hypertension

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Liyun Yu	Contact	13683217693		yu_li_yun@sina.com

Overall Officials

Name	Affiliation	Role
Xiaohong Wu	Beijing Electric Power Hospital	Principal Investigator

Locations

Not provided

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided