Coronary Artery DiseaseNCT03358680
Temperature and Analgesia Monitoring During Cardial Parmonary Bypass
An observational study of Coronary Artery Disease, run by China International Neuroscience Institution at 1 site in China.
Trial summary
1. Investigator will apply IOC2 to reflect the depth of analgesic during hypothermia in CPB period. 2. effectiveness of IOC2 monitoring for anesthetic depth versus commonly used vital sign monitoring based on factors such as blood pressure and heart rate. 3. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- noninvasive analgesia measurement
- Type of treatment
- Medical device
- How many people
- 39 participants
- Where
- 1 siteChina
- Study dates
- 1 May 2017to 19 Sep 2017
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: the patients schedule undergoing coronary artery bypass surgery
Who may be able to join
- undergoing coronary artery bypass surgery
Who cannot join
- change the surgery planning during the operation
Trial locations and contacts
1 site in 1 country.
About this study
- Investigator will apply IOC2 to reflect the depth of analgesic during hypothermia in CPB period.
- effectiveness of IOC2 monitoring for anesthetic depth versus commonly used vital sign monitoring based on factors such as blood pressure and heart rate.
- Evaluate the other sedation co-relation measurement, include BIS , IOC2 to reflected the consciousness during the operation.
- Evaluate the other hemodynamic index, include CO, SVV, CVP, PPV to reflect the circulation function , and the effect to the IOC2 and IOC1.
- Describe the trend of all the measurement. detect the variation of the index during the temperature change during the CPB.
Read the detailed description
In this study,
- Investigator will apply IOC2 to reflect the depth of analgesic during hypothermia in CPB period.
- Furthermore, investigator evaluated the effectiveness of IOC2 monitoring for anesthetic depth versus commonly used vital sign monitoring based on factors such as blood pressure and heart rate.
- Evaluate the other sedation co-relation measurement, include BIS , IOC2 to reflected the consciousness during the operation.
- Evaluate the other hemodynamic index, include CO, SVV, CVP, PPV to reflect the circulation function , and the effect to the IOC2 and IOC1.
- Describe the trend of all the measurement. detect the variation of the index during the temperature change during the CPB.
- Conditions
- Coronary Artery Disease
- Being tested
- noninvasive analgesia measurement
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
noninvasive analgesia measurementDevice
Also called index of consciousness(IOC2)
noninvasive analgesia measurement using index of consciousness(IOC2)
What is being measured
The primary outcome is the main question the study is designed to answer.
IOC2
Index of consciousness 2
Measured: 1 DAY
Secondary outcomes (2)
BIS
to monitor and compare appropriate conscious value
Measured: 1 DAY
IOC1
index of consciousness 1
Measured: 1 DAY
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2017
- Study start1 May 2017
- Primary completion1 Sep 2017
- Study completion19 Sep 2017
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.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- China International Neuroscience Institution
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Zhaolong Tian, MS, Principal investigator, Xuanwu Hospital, Beijing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03358680
- Sponsor's protocol ID
- ZYLX201706-11025
- Status last verified
- Aug 2018
- First submitted
- 13 Nov 2017
- Last updated
- 7 Aug 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Temperature and Analgesia Monitoring During Cardial Parmonary Bypass
- ClinicalTrials.gov ID
- NCT03358680
- Acronym / sponsor ID
- ZYLX201706-11025
- Conditions
- Coronary Artery Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- China International Neuroscience InstitutionUniversity, hospital or other
- Study start
- 1 May 2017 (actual)
- Primary completion
- 1 Sep 2017 (actual)
- Study completion
- 19 Sep 2017 (actual)
- First posted
- 30 Nov 2017 (actual)
- 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.
- Investigator will apply IOC2 to reflect the depth of analgesic during hypothermia in CPB period.
- effectiveness of IOC2 monitoring for anesthetic depth versus commonly used vital sign monitoring based on factors such as blood pressure and heart rate.
- Evaluate the other sedation co-relation measurement, include BIS , IOC2 to reflected the consciousness during the operation.
- Evaluate the other hemodynamic index, include CO, SVV, CVP, PPV to reflect the circulation function , and the effect to the IOC2 and IOC1.
- Describe the trend of all the measurement. detect the variation of the index during the temperature change during the CPB.
Detailed description
In this study,
- Investigator will apply IOC2 to reflect the depth of analgesic during hypothermia in CPB period.
- Furthermore, investigator evaluated the effectiveness of IOC2 monitoring for anesthetic depth versus commonly used vital sign monitoring based on factors such as blood pressure and heart rate.
- Evaluate the other sedation co-relation measurement, include BIS , IOC2 to reflected the consciousness during the operation.
- Evaluate the other hemodynamic index, include CO, SVV, CVP, PPV to reflect the circulation function , and the effect to the IOC2 and IOC1.
- Describe the trend of all the measurement. detect the variation of the index during the temperature change during the CPB.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- the patients schedule undergoing coronary artery bypass surgery
Key inclusion criteria (1 listed)
- undergoing coronary artery bypass surgery
Key exclusion criteria (1 listed)
- change the surgery planning during the operation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| noninvasive analgesia measurementAlso: index of consciousness(IOC2)noninvasive analgesia measurement using index of consciousness(IOC2) | Device | – |
Primary outcome
IOC2
Time frame: 1 DAY
Index of consciousness 2
2 secondary outcomes
BIS
Time frame: 1 DAY
IOC1
Time frame: 1 DAY
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2018.
Related trials for Coronary Artery Disease
Not yet recruiting
Effect of Stress Ball Use During Femoral Arterial Sheath Removal After Coronary Angiography
Femoral Arterial Sheath Removal, Stress Ball
Active, not recruiting
Shockwave™ vs Surgical Endarterectomy for Calcified Severe Common Femoral Artery Stenosis: Comparison of Efficacy, Safety and Long-Term Outcomes
Common Femoral Artery Stenosis, Calcification; Heart
Not yet recruitingPhase 4
Roxadustat and Myocardial Injury After Off-Pump Coronary Artery Bypass Surgery
Coronary Artery Disease, Coronary Artery Bypass Grafting
RecruitingObservational study
Preoperative Gastric Ultrasound and Left Ventricular Function in Coronary Artery Bypass Surgery
Coronary Artery Disease, Left Ventricular Systolic Dysfunction
Active, not recruiting
The OCTOBER Trial - European Trial on Optical Coherence Tomography Optimized Bifurcation Event Reduction (OCTOBER)
Ischaemic Heart Disease, Ischemic Heart Disease
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.
Zhaolong Tian, MS principal investigator
Xuanwu Hospital, Beijing
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 China International Neuroscience Institution at 1 site in China.
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 1 inclusion and 1 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: finished, as of the sponsor's last update on 7 Aug 2018. 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 China. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
IOC2 (time frame: 1 DAY). 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 7 Aug 2018.