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

NCT ID: NCT01932346

Last Updated: 2014-02-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-08-31

Study Completion Date

2015-03-31

Brief Summary

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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

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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.

Conditions

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Coronary Artery Disease

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

CROSS_SECTIONAL

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Taiwan University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Po-Yuan Shih

Role: PRINCIPAL_INVESTIGATOR

National Taiwan University Hospital

Locations

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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

Site Status RECRUITING

Countries

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Taiwan

Central Contacts

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Po-Yuan Shih

Role: CONTACT

Facility Contacts

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Po-Yuan Shih

Role: primary

Other Identifiers

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201201016RIC

Identifier Type: -

Identifier Source: org_study_id

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