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

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ClinicalTrials.gov Identifier: NCT01932346
Recruitment Status : Unknown
Verified February 2014 by National Taiwan University Hospital.
Recruitment status was:  Recruiting
First Posted : August 30, 2013
Last Update Posted : February 24, 2014
Information provided by (Responsible Party):
National Taiwan University Hospital

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.

Condition or disease
Coronary Artery Disease

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.

Study Type : Observational
Estimated Enrollment : 50 participants
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
Study Start Date : August 2013
Estimated Primary Completion Date : March 2015
Estimated Study Completion Date : March 2015

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Primary Outcome Measures :
  1. 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%).

Information from the National Library of Medicine

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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01932346

Contact: Po-Yuan Shih b87401084@ntu.edu.tw

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       b87401084@ntu.edu.tw   
Sponsors and Collaborators
National Taiwan University Hospital
Principal Investigator: Po-Yuan Shih National Taiwan University Hospital

Responsible Party: National Taiwan University Hospital
ClinicalTrials.gov Identifier: NCT01932346     History of Changes
Other Study ID Numbers: 201201016RIC
First Posted: August 30, 2013    Key Record Dates
Last Update Posted: February 24, 2014
Last Verified: February 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