Study on the Neurovascular Coupling Function in Patients Undergoing Cardiac Surgery
1 other identifier
observational
30
0 countries
N/A
Brief 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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2016
CompletedFirst Submitted
Initial submission to the registry
November 16, 2016
CompletedFirst Posted
Study publicly available on registry
November 30, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2017
CompletedNovember 30, 2016
October 1, 2016
5 months
November 16, 2016
November 27, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
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
6 months
Eligibility Criteria
Cardiac surgery patients
You may qualify if:
- 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)
You may not qualify if:
- 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.
- Participated in other clinical trials
- Perioperative stroke
- The researchers believe that should not be included in the study
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 16, 2016
First Posted
November 30, 2016
Study Start
October 1, 2016
Primary Completion
March 1, 2017
Last Updated
November 30, 2016
Record last verified: 2016-10