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Status unknownNCT01932346Updated Feb 24, 2014

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

An observational study in Coronary Artery Disease, sponsored by National Taiwan University Hospital. Status unknown at 1 site in Taiwan. Open to participants aged 20 Years to 75 Years. Per ClinicalTrials.gov, last updated 2014-02-24.

Sponsored by National Taiwan University Hospital · Observational

The sponsor has not verified this record recently (last verified Feb 2014), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Case-only
Time perspective
Cross-sectional
Enrollment
50
Ages
20 Years to 75 Years
Sex
All
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Study 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.

Read the 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.

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Conditions studied

  • Coronary Artery Disease

Keywords

  • near infra-red spectroscopy, coronary artery bypass grafting
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In context

Coronary Artery Disease

5,598 studies on the registry are indexed under Coronary Artery Disease; 957 are open to participants now.

This study's planned enrollment of 50 is below the median of 336 across 1,947 observational studies indexed under Coronary Artery Disease.

Browse Coronary Artery Disease studies →

Lead sponsor

National Taiwan University Hospital is the lead sponsor of 2,563 studies on the registry; 569 are open to participants now.

Of its 11 completed or terminated interventional studies of FDA-regulated products, 2 (18%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 75 Years
Sexes eligible
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

Exclusion Criteria:

  • Patients scheduled for cardiopulmonary bypass
  • Allergy for NIRS
05

Study design

Observational model
Case-only
Time perspective
Cross-sectional
Enrollment
50 participants (estimated)
Patient registry
No
06

What researchers measure

Primary outcomes

  1. Percentage of tissue oxygen saturation (StO2)

    The measured tissue oxygen saturation is shown in the form of percentage (0\~100%).

    Time frame: every 5 minute, from the induction of anesthesia to the end of the surgery, estimated duration: 4 hours

07

Study locations

1 of 1 sites recruiting
  • 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
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 24, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01932346
Lead sponsor
National Taiwan University Hospital
Responsible party
Sponsor
First posted
Aug 30, 2013
Start date
Aug 2013
Primary completion
Mar 2015 (estimated)
Completion
Mar 2015 (estimated)
Last update
Feb 24, 2014

Study contacts

Po-Yuan Shih
Contact
b87401084@ntu.edu.tw
Po-Yuan Shih
principal investigator · National Taiwan University Hospital

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Feb 2014. You cannot join it, but the record below documents what was studied.

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