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

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2014 by National Taiwan University Hospital
Sponsor:
Information provided by (Responsible Party):
National Taiwan University Hospital
ClinicalTrials.gov Identifier:
NCT01932346
First received: August 12, 2013
Last updated: February 21, 2014
Last verified: February 2014

August 12, 2013
February 21, 2014
August 2013
March 2015   (final data collection date for primary outcome measure)
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 ] [ Designated as safety issue: No ]
The measured tissue oxygen saturation is shown in the form of percentage (0~100%).
Same as current
Complete list of historical versions of study NCT01932346 on ClinicalTrials.gov Archive Site
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Using Near Infra-red Spectroscopy to Measure Tissue Perfusion in Patients Receiving Coronary Artery Bypass Graft Surgery
Using Non-invasive Near Infra-red Spectroscopy to Measure the Regional Tissue Perfusion in Patients Receiving Off-pump Coronary Artery Bypass Graft Surgery

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.

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.

Observational
Observational Model: Case-Only
Time Perspective: Cross-Sectional
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Probability Sample

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

Coronary Artery Disease
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
50
March 2015
March 2015   (final data collection date for primary outcome measure)

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
Both
20 Years to 75 Years
No
Contact: Po-Yuan Shih b87401084@ntu.edu.tw
Taiwan
 
NCT01932346
201201016RIC
No
National Taiwan University Hospital
National Taiwan University Hospital
Not Provided
Principal Investigator: Po-Yuan Shih National Taiwan University Hospital
National Taiwan University Hospital
February 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP