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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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01932346
Enrollment
50
Registered
2013-08-30
Start date
2013-08-31
Completion date
2015-03-31
Last updated
2014-02-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coronary Artery Disease

Keywords

near infra-red spectroscopy, coronary artery bypass grafting

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.

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.

Interventions

None listed

Sponsors

National Taiwan University Hospital
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
20 Years to 75 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Percentage of tissue oxygen saturation (StO2)every 5 minute, from the induction of anesthesia to the end of the surgery, estimated duration: 4 hoursThe measured tissue oxygen saturation is shown in the form of percentage (0\ 100%).

Countries

Taiwan

Contacts

Primary ContactPo-Yuan Shih
b87401084@ntu.edu.tw

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026