Try our beta test site
IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...

Using Near Infra-red Spectroscopy to Measure Tissue Perfusion in Patients Receiving Coronary Artery Bypass Graft Surgery

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified February 2014 by National Taiwan University Hospital.
Recruitment status was:  Recruiting
Information provided by (Responsible Party):
National Taiwan University Hospital Identifier:
First received: August 12, 2013
Last updated: February 21, 2014
Last verified: February 2014
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.

Coronary Artery Disease

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Cross-Sectional
Official Title: Using Non-invasive Near Infra-red Spectroscopy to Measure the Regional Tissue Perfusion in Patients Receiving Off-pump Coronary Artery Bypass Graft Surgery

Resource links provided by NLM:

Further study details as provided by National Taiwan University Hospital:

Primary Outcome Measures:
  • Percentage of tissue oxygen saturation (StO2) [ Time Frame: every 5 minute, from the induction of anesthesia to the end of the surgery, estimated duration: 4 hours ]
    The measured tissue oxygen saturation is shown in the form of percentage (0~100%).

Estimated Enrollment: 50
Study Start Date: August 2013
Estimated Study Completion Date: March 2015
Estimated Primary Completion Date: March 2015 (Final data collection date for primary outcome measure)
Detailed Description:

Study Design:

Prospective observational study

Target Number of Participants:

To recruit 50 patients into this study.

Patient Selection:

  1. Patients scheduled for elective coronary artery bypass surgery.
  2. The American Society of Anesthesiologists physical status classification system(ASA) Class I~III
  3. Age ≧20 y/o, ≦75 y/o

Exclusion Criteria:

  1. ASA Class IV
  2. Current skin lesion over the sites where the NIRS patches are designed to be attached.
  3. Patients received cardiopulmonary bypass during the surgery.
  4. Patients with previous history of allergy to the NIRS patches.

Study Method:

After the induction of anesthesia, four NIRS patches are attached to the patients on the following sites:

  1. Biceps brachii muscle area
  2. Gastrocnemius muscle area
  3. Posterior side of neck
  4. central part of the forehead

The four non-invasive NIRS patches are only to measure the tissue oxygen saturation and have no other physiological effects on the participants.

The data will be collected every 5 minutes until the surgery is completed. The data from other routine monitors used during the surgery (including hear rate, blood pressure, and mixed venous saturation) will also be used to compare with the data from NIRS.


Ages Eligible for Study:   20 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients scheduled for elective coronary artery bypass surgery and age ≧20 years old, ≦75 years old

Inclusion Criteria:

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

Exclusion Criteria:

  • Patients scheduled for cardiopulmonary bypass
  • Allergy for NIRS
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01932346

Contact: Po-Yuan Shih

Using non-invasive near infra-red spectroscopy to measure the regional tissue perfusion in patients receiving off-pump coronary artery bypass graft surgery Recruiting
Taipei, Taiwan
Contact: Po-Yuan Shih   
Sponsors and Collaborators
National Taiwan University Hospital
Principal Investigator: Po-Yuan Shih National Taiwan University Hospital
  More Information

Responsible Party: National Taiwan University Hospital Identifier: NCT01932346     History of Changes
Other Study ID Numbers: 201201016RIC
Study First Received: August 12, 2013
Last Updated: February 21, 2014

Keywords provided by National Taiwan University Hospital:
near infra-red spectroscopy, coronary artery bypass grafting

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arterial Occlusive Diseases
Vascular Diseases processed this record on May 25, 2017