NCT01932346

Brief Summary

Near infra-red spectroscopy (NIRS) was used to measure the tissue perfusion of the cerebral cortex with two noninvasive adhesive patches in recent years. This study is designed to compare the regional tissue perfusion of different body areas in patients receiving coronary artery bypass surgery under general anesthesia. The NIRS data will also be used to compare with other routine physiological monitors in the surgery.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Aug 2013

Geographic Reach
1 country

1 active site

Status
unknown

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

August 1, 2013

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

August 12, 2013

Completed
18 days until next milestone

First Posted

Study publicly available on registry

August 30, 2013

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2015

Completed
Last Updated

February 24, 2014

Status Verified

February 1, 2014

Enrollment Period

1.6 years

First QC Date

August 12, 2013

Last Update Submit

February 21, 2014

Conditions

Coronary Artery Disease

Keywords

near infra-red spectroscopy, coronary artery bypass grafting

Outcome Measures

Primary Outcomes (1)

  • Percentage of tissue oxygen saturation (StO2)

    The measured tissue oxygen saturation is shown in the form of percentage (0\~100%).

    every 5 minute, from the induction of anesthesia to the end of the surgery, estimated duration: 4 hours

Eligibility Criteria

Age20 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients scheduled for elective coronary artery bypass surgery and age ≧20 years old, ≦75 years old

You may qualify if:

  • Age ≧20 years old, ≦75 years old
  • Patients scheduled for elective coronary artery bypass surgery
  • ASA Class I\~III

You may not qualify if:

  • Patients scheduled for cardiopulmonary bypass
  • Allergy for NIRS

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Using non-invasive near infra-red spectroscopy to measure the regional tissue perfusion in patients receiving off-pump coronary artery bypass graft surgery

Taipei, Taiwan

RECRUITING

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Study Officials

  • Po-Yuan Shih

    National Taiwan University Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Po-Yuan Shih

CONTACT

b87401084@ntu.edu.tw

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 12, 2013

First Posted

August 30, 2013

Study Start

August 1, 2013

Primary Completion

March 1, 2015

Study Completion

March 1, 2015

Last Updated

February 24, 2014

Record last verified: 2014-02

Locations

TW(1)