Temperature and Analgesia Monitoring During Cardial Parmo... | NCT03358680

Studies
Temperature and Analgesia Monitoring During Cardial Parmonary Bypass

NCT03358680

Sponsor

China International Neuroscience Institution

Status

Completed

Last Update Posted

Aug 7, 2018Actual

Enrollment

39Actual

Phase

Not provided

Conditions

Coronary Artery Disease

Interventions

noninvasive analgesia measurement

Countries

China

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

Aug 2018

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

May 1, 2017Actual

Primary Completion Date

Sep 1, 2017Actual

Completion Date

Sep 19, 2017Actual

First Submitted Date

Nov 13, 2017

First Submission Date that Met QC Criteria

Nov 29, 2017

First Posted Date

Nov 30, 2017Actual

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

Aug 4, 2018

Last Update Posted Date

Aug 7, 2018Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

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

Investigator will apply IOC2 to reflect the depth of analgesic during hypothermia in CPB period.
effectiveness of IOC2 monitoring for anesthetic depth versus commonly used vital sign monitoring based on factors such as blood pressure and heart rate.
Evaluate the other sedation co-relation measurement, include BIS , IOC2 to reflected the consciousness during the operation.
Evaluate the other hemodynamic index, include CO, SVV, CVP, PPV to reflect the circulation function , and the effect to the IOC2 and IOC1.
Describe the trend of all the measurement. detect the variation of the index during the temperature change during the CPB.

Detailed Description

In this study,

Investigator will apply IOC2 to reflect the depth of analgesic during hypothermia in CPB period.
Furthermore, investigator evaluated the effectiveness of IOC2 monitoring for anesthetic depth versus commonly used vital sign monitoring based on factors such as blood pressure and heart rate.
Evaluate the other sedation co-relation measurement, include BIS , IOC2 to reflected the consciousness during the operation.
Evaluate the other hemodynamic index, include CO, SVV, CVP, PPV to reflect the circulation function , and the effect to the IOC2 and IOC1.
Describe the trend of all the measurement. detect the variation of the index during the temperature change during the CPB.

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

39Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
noninvasive analgesia measurement	Device	noninvasive analgesia measurement using index of consciousness(IOC2)		index of consciousness(IOC2)

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
IOC2	Index of consciousness 2	1 DAY

Secondary Outcomes

Measure	Description	Time Frame
BIS	to monitor and compare appropriate conscious value	1 DAY
IOC1	index of consciousness 1	1 DAY

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

undergoing coronary artery bypass surgery

Exclusion Criteria:

change the surgery planning during the operation

Accepts Healthy Volunteers

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

the patients schedule undergoing coronary artery bypass surgery

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Zhaolong Tian, MS	Xuanwu Hospital, Beijing	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Xuanwu Hospital		Beijing	Beijing Municipality	100053	China

Condition Browse Module

MeSH Terms

ID	Term
D003324	Coronary Artery Disease

Ancestor Terms

ID	Term
D003327	Coronary Disease
D017202	Myocardial Ischemia
D006331	Heart Diseases
D002318	Cardiovascular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided