NCT03358680

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
39

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started May 2017

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2017

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2017

Completed
18 days until next milestone

Study Completion

Last participant's last visit for all outcomes

September 19, 2017

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

November 13, 2017

Completed
17 days until next milestone

First Posted

Study publicly available on registry

November 30, 2017

Completed
Last Updated

August 7, 2018

Status Verified

August 1, 2018

Enrollment Period

4 months

First QC Date

November 13, 2017

Last Update Submit

August 4, 2018

Conditions

Coronary Artery Disease

Outcome Measures

Primary Outcomes (1)

  • IOC2

    Index of consciousness 2

    1 DAY

Secondary Outcomes (2)

  • BIS

    1 DAY

  • IOC1

    1 DAY

Interventions

noninvasive analgesia measurementDEVICE

noninvasive analgesia measurement using index of consciousness(IOC2)

Also known as: index of consciousness(IOC2)

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

the patients schedule undergoing coronary artery bypass surgery

You may qualify if:

  • undergoing coronary artery bypass surgery

You may not qualify if:

  • change the surgery planning during the operation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Xuanwu Hospital

Beijing, Beijing Municipality, 100053, China

Location

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Study Officials

  • Zhaolong Tian, MS

    Xuanwu Hospital, Beijing

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 13, 2017

First Posted

November 30, 2017

Study Start

May 1, 2017

Primary Completion

September 1, 2017

Study Completion

September 19, 2017

Last Updated

August 7, 2018

Record last verified: 2018-08

Locations

CN(1)