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

Coronary Artery Disease Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01932346
• Other study ID #: 201201016RIC
• Status: Recruiting
• Phase: N/A
• First received: August 12, 2013
• Last updated: February 21, 2014
• Start date: August 2013
• Est. completion date: March 2015

Study information

• Verified date: February 2014
• Source: National Taiwan University Hospital
• Contact: Po-Yuan Shih
• Email: b87401084[@]ntu.edu.tw
• Is FDA regulated: No
• Health authority: Taiwan: Department of Health
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: March 2015
• Est. primary completion date: March 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 75 Years

Eligibility

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

Study Design

Observational Model: Case-Only, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Locations

Country	Name	City	State
Taiwan	Using non-invasive near infra-red spectroscopy to measure the regional tissue perfusion in patients receiving off-pump coronary artery bypass graft surgery	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
National Taiwan University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of tissue oxygen saturation (StO2)	The measured tissue oxygen saturation is shown in the form of percentage (0~100%).	every 5 minute, from the induction of anesthesia to the end of the surgery, estimated duration: 4 hours	No