Neurovascular Coupling Mechanism and Cognitive FunctionNCT02977455
Study on the Neurovascular Coupling Function in Patients Undergoing Cardiac Surgery
An observational study of Neurovascular Coupling Mechanism and Cognitive Function, run by Xiangya Hospital of Central South University.
Trial summary
Existing researches show that brain is an organ highly dependent on continuous blood supply. Energy and oxygen required for normal physiological activities in the brain are stably maintained by a neurovascular regulatory mechanism, also known as functional congestion. Read more about this study
- Who is it for?
- Ages 2 to 12 years
- Conditions the study is for
- Neurovascular Coupling Mechanism and Cognitive Function
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- Oct 2016to Mar 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 2 to 12 years
- All sexes
- No healthy volunteers
- Child
Study population: Cardiac surgery patients
Who may be able to join
- Age <12 years old
- Will take cardiac surgery and general anesthesia
- Cognitive status is normal
- Cardiac function grade Ⅱ-Ⅲ (using the NYHA cardiac function classification)
Who cannot join
- Emergency surgery
- ASA-V or VI
- Coagulation disorders,multiple organs dysfunction, endocrine system diseases and severe infectious diseases
- Patients have been installed pacemakers
- Suspected or indeed alcohol, drug abuse history
- Can not cooperate with research, such as the following: language understanding, mental illness, etc.
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- Participated in other clinical trials
- Perioperative stroke
- The researchers believe that should not be included in the study
About this study
Existing researches show that brain is an organ highly dependent on continuous blood supply. Energy and oxygen required for normal physiological activities in the brain are stably maintained by a neurovascular regulatory mechanism, also known as functional congestion. While under pathological condition such as ischemia, this regulatory mechanism would be impaired and brain function loss and tissue damage occur. During anesthesia in cardiac surgery, inevitable circulatory fluctuations could result in decreasing blood pressure and cerebral blood flow and therefore brain tissue is in ischemia. In this situation the neurovascular regulatory mechanism will function and the brain oxygen saturation also changes based on how this mechanism is influenced. the investigators were devoted to observe how this mechanism was influenced during surgery and how the neural function recovers after surgery so to explore the relationship between them.
Read the detailed description
Preoperative: Routine examinations, including pulse, blood pressure, electrocardiogram, hematological and biochemical tests from blood and urine. Anesthetist paid visit to patient and made judgement whether patient could be included or not based on rating of cognition. Anesthetist also introduced the research plan in detail and patient or guardian signed consent out of participants' own free will.
Intraoperative:
- After admission, the investigators recorded regular vital signs and measured basic cerebral oxygen saturation, then inducted anesthesia.
- After induction the investigators recorded anesthetic dose, vital signs and measured cerebral blood flow and oxygen saturation changes.
- Using BIS to monitor we controlled the anesthesia depth at BIS value of 40 to 60.
- Assuring patient's vital signs to be stable and safe, the investigators gave propofol (3 mg/kg, from Fresenius Kabi) intravenously when BIS was greater than 60 and observed while recorded any changes in BIS value, cerebral blood flow and oxygen saturation.
Postoperative: Patient was transferred to chest surgery ICU and vital signs were recorded.
Clinical data record:
General information: including name, gender, age, height, weight, education, name of disease, surgery method, admission number, ID number, address, contact information and so on;
Preoperative: cardiovascular medicine, vasoactive drugs, lab test results, result reviews, cognition rating and cerebral blood oxygen saturation basic value;
Intraoperative: circulatory parameters, medicine, temperature, BIS value, cerebral blood oxygen saturation and blood flow parameters;
Postoperative: extubation time, time of vasoactive drug administration, cognition rating (postoperative day 3 and day 7), postoperative complications (sudden cardiac death, disturbance of consciousness, pulmonary infection, acute lung injury, acute pulmonary embolism, cerebral infarction and so on);
Postoperative stay in hospital, ICU stay time, hospitalization cost, readmission, mortality (one, three and six months) and so on.
Cognition rating chart: based on "Direction of Chinese Binet Tests (third edition)".
What is being measured
The primary outcome is the main question the study is designed to answer.
Thirty of participants with Cognitive function assessment based on "Direction of Chinese Binet Tests (third edition)"
IQ scores will be used to quantify cognitive function
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2016 (estimated)
- Study startOct 2016
- Primary completionMar 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neurovascular Coupling Mechanism and Cognitive FunctionStudies 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
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xiangya Hospital of Central South University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02977455
- Sponsor's protocol ID
- 304460568
- Status last verified
- Oct 2016
- First submitted
- 16 Nov 2016
- Last updated
- 30 Nov 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study on the Neurovascular Coupling Function in Patients Undergoing Cardiac Surgery
- ClinicalTrials.gov ID
- NCT02977455
- Acronym / sponsor ID
- 304460568
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Xiangya Hospital of Central South UniversityUniversity, hospital or other
- Study start
- Oct 2016
- Primary completion
- Mar 2017 (estimated)
- First posted
- 30 Nov 2016 (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.
Existing researches show that brain is an organ highly dependent on continuous blood supply. Energy and oxygen required for normal physiological activities in the brain are stably maintained by a neurovascular regulatory mechanism, also known as functional congestion. While under pathological condition such as ischemia, this regulatory mechanism would be impaired and brain function loss and tissue damage occur. During anesthesia in cardiac surgery, inevitable circulatory fluctuations could result in decreasing blood pressure and cerebral blood flow and therefore brain tissue is in ischemia. In this situation the neurovascular regulatory mechanism will function and the brain oxygen saturation also changes based on how this mechanism is influenced. the investigators were devoted to observe how this mechanism was influenced during surgery and how the neural function recovers after surgery so to explore the relationship between them.
Detailed description
Preoperative: Routine examinations, including pulse, blood pressure, electrocardiogram, hematological and biochemical tests from blood and urine. Anesthetist paid visit to patient and made judgement whether patient could be included or not based on rating of cognition. Anesthetist also introduced the research plan in detail and patient or guardian signed consent out of participants' own free will.
Intraoperative:
- After admission, the investigators recorded regular vital signs and measured basic cerebral oxygen saturation, then inducted anesthesia.
- After induction the investigators recorded anesthetic dose, vital signs and measured cerebral blood flow and oxygen saturation changes.
- Using BIS to monitor we controlled the anesthesia depth at BIS value of 40 to 60.
- Assuring patient's vital signs to be stable and safe, the investigators gave propofol (3 mg/kg, from Fresenius Kabi) intravenously when BIS was greater than 60 and observed while recorded any changes in BIS value, cerebral blood flow and oxygen saturation.
Postoperative: Patient was transferred to chest surgery ICU and vital signs were recorded.
Clinical data record:
General information: including name, gender, age, height, weight, education, name of disease, surgery method, admission number, ID number, address, contact information and so on;
Preoperative: cardiovascular medicine, vasoactive drugs, lab test results, result reviews, cognition rating and cerebral blood oxygen saturation basic value;
Intraoperative: circulatory parameters, medicine, temperature, BIS value, cerebral blood oxygen saturation and blood flow parameters;
Postoperative: extubation time, time of vasoactive drug administration, cognition rating (postoperative day 3 and day 7), postoperative complications (sudden cardiac death, disturbance of consciousness, pulmonary infection, acute lung injury, acute pulmonary embolism, cerebral infarction and so on);
Postoperative stay in hospital, ICU stay time, hospitalization cost, readmission, mortality (one, three and six months) and so on.
Cognition rating chart: based on "Direction of Chinese Binet Tests (third edition)".
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 2 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Cardiac surgery patients
Key inclusion criteria (4 listed)
- Age <12 years old
- Will take cardiac surgery and general anesthesia
- Cognitive status is normal
- Cardiac function grade Ⅱ-Ⅲ (using the NYHA cardiac function classification)
Key exclusion criteria (9 listed)
- Emergency surgery
- ASA-V or VI
- Coagulation disorders,multiple organs dysfunction, endocrine system diseases and severe infectious diseases
- Patients have been installed pacemakers
- Suspected or indeed alcohol, drug abuse history
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
Thirty of participants with Cognitive function assessment based on "Direction of Chinese Binet Tests (third edition)"
Time frame: 6 months
IQ scores will be used to quantify cognitive function
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Nov 2016.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Neurovascular Coupling Mechanism and Cognitive Function, run by Xiangya Hospital of Central South University.
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 4 inclusion and 9 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 30 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
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?
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?
Thirty of participants with Cognitive function assessment based on "Direction of Chinese Binet Tests (third edition)" (time frame: 6 months). 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 30 Nov 2016.