Coronary Artery DiseaseNCT01932346
Using Near Infra-red Spectroscopy to Measure Tissue Perfusion in Patients Receiving Coronary Artery Bypass Graft Surgery
An observational study of Coronary Artery Disease, run by National Taiwan University Hospital at 1 site in Taiwan.
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… Read more about this study
- Who is it for?
- Ages 20 to 75 years
- Conditions the study is for
- Coronary Artery Disease
- How many people
- 50 participants
- Where
- 1 siteTaiwan
- Study dates
- Aug 2013to Mar 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients scheduled for elective coronary artery bypass surgery and age ≧20 years old, ≦75 years old
Who may be able to join
- Age ≧20 years old, ≦75 years old
- Patients scheduled for elective coronary artery bypass surgery
- ASA Class I~III
Who cannot join
- Patients scheduled for cardiopulmonary bypass
- Allergy for NIRS
Trial locations and contacts
1 site in 1 country.
Po-Yuan Shih contact
Taiwan1 site, 1 recruiting
- 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
Po-Yuan Shih, b87401084@ntu.edu.tw
About this study
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
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:
- Patients scheduled for elective coronary artery bypass surgery.
- The American Society of Anesthesiologists physical status classification system(ASA) Class I~III
- Age ≧20 y/o, ≦75 y/o
Exclusion Criteria:
- ASA Class IV
- Current skin lesion over the sites where the NIRS patches are designed to be attached.
- Patients received cardiopulmonary bypass during the surgery.
- 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:
- Biceps brachii muscle area
- Gastrocnemius muscle area
- Posterior side of neck
- 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
- Coronary Artery Disease
- Keywords
- near infra-red spectroscopy, coronary artery bypass grafting
- Medical subject headings
- Coronary Artery Disease
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of tissue oxygen saturation (StO2)
The measured tissue oxygen saturation is shown in the form of percentage (0~100%).
Measured: every 5 minute, from the induction of anesthesia to the end of the surgery, estimated duration: 4 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2013 (estimated)
- Study startAug 2013
- Primary completionMar 2015 (estimated)
- Study completionMar 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Po-Yuan Shih, Principal investigator, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01932346
- Sponsor's protocol ID
- 201201016RIC
- Status last verified
- Feb 2014
- First submitted
- 12 Aug 2013
- Last updated
- 24 Feb 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01932346
- Acronym / sponsor ID
- 201201016RIC
- Conditions
- Coronary Artery Disease
- Keywords
- near infra-red spectroscopy, coronary artery bypass grafting
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- Aug 2013
- Primary completion
- Mar 2015 (estimated)
- Study completion
- Mar 2015 (estimated)
- First posted
- 30 Aug 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Patients scheduled for elective coronary artery bypass surgery.
- The American Society of Anesthesiologists physical status classification system(ASA) Class I~III
- Age ≧20 y/o, ≦75 y/o
Exclusion Criteria:
- ASA Class IV
- Current skin lesion over the sites where the NIRS patches are designed to be attached.
- Patients received cardiopulmonary bypass during the surgery.
- 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:
- Biceps brachii muscle area
- Gastrocnemius muscle area
- Posterior side of neck
- 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.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients scheduled for elective coronary artery bypass surgery and age ≧20 years old, ≦75 years old
Key inclusion criteria (3 listed)
- Age ≧20 years old, ≦75 years old
- Patients scheduled for elective coronary artery bypass surgery
- ASA Class I~III
Key exclusion criteria (2 listed)
- Patients scheduled for cardiopulmonary bypass
- Allergy for NIRS
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
The measured tissue oxygen saturation is shown in the form of percentage (0~100%).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Po-Yuan Shih contact
Po-Yuan Shih principal investigator
National Taiwan University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Artery Disease, run by National Taiwan University Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Feb 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Po-Yuan Shih (b87401084@ntu.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Feb 2014.