NCT02977455

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

50
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for all trials

Status
unknown

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

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

November 16, 2016

Completed
14 days until next milestone

First Posted

Study publicly available on registry

November 30, 2016

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2017

Completed
Last Updated

November 30, 2016

Status Verified

October 1, 2016

Enrollment Period

5 months

First QC Date

November 16, 2016

Last Update Submit

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

Age2 Years - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

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