Cerebral Blood FlowNCT02959008
Continous Assessment of Cerebral Autoregulation With Near-infrared Spectroscopy
An observational study of Cerebral Blood Flow and Cerebral Perfusion Pressure, run by Yu Liyun.
Trial summary
Cerebral autoregulation can be explained by a tight coupling between oxygen supply and demand of the brain, and is essential to maintain a constant cerebral blood flow (CBF) in the context of changes in cerebral perfusion pressure. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Cerebral Blood Flow, Cerebral Perfusion Pressure
- What is being tested?
- measure TOI and BP
- Type of treatment
- Medical device
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- Dec 2016to Dec 2019
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: 1. adult 2. health people 3. people with hypertension
Who may be able to join
- health people, or people with hypertension
Who cannot join
- diabetes, anemia, liver disease, kidney disease.
Trial locations and contacts
No sites are listed yet.
About this study
Cerebral autoregulation can be explained by a tight coupling between oxygen supply and demand of the brain, and is essential to maintain a constant cerebral blood flow (CBF) in the context of changes in cerebral perfusion pressure. In this study, investigators use Near-infrared spectroscopy (NIRS) to monitor cerebral autoregulation.
Read the detailed description
Near-infrared spectroscopy (NIRS) is a noninvasive technology that real-time monitors cerebral tissue oxygenation index (TOI). Investigators use Near-infrared spectroscopy (NIRS) to monitor cerebral autoregulation of hypertensive participants and non-hypertensive participants.
- Conditions
- Cerebral Blood Flow, Cerebral Perfusion Pressure
- Being tested
- measure TOI and BP
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
measure TOI and BPDevice
Both groups measure TOI and BP.
| Study group | Role | What they receive |
|---|---|---|
| normal | Human without hypertension, diabetes, anemia, liver disease and kidney disease. The group will measure TOI and BP. Receives: Device: measure TOI and BP | |
| hypertension | Human only have hypertension, without diabetes, anemia, liver disease and kidney disease.
Hypertension group will measure TOI and BP. Receives: Device: measure TOI and BP |
What is being measured
The primary outcome is the main question the study is designed to answer.
range of cerebral autoregulation
Measured: 30min
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2016 (estimated)
- Study startDec 2016
- Primary completionDec 2018 (estimated)
- Study completionDec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebral Blood FlowStudies 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
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yu Liyun
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Yu Liyun, Beijing Electric Power Hospital
- Investigators
- Xiaohong Wu, Principal investigator, Beijing Electric Power Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02959008
- Sponsor's protocol ID
- 111
- Status last verified
- Nov 2016
- First submitted
- 5 Nov 2016
- Last updated
- 16 Nov 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Continous Assessment of Cerebral Autoregulation With Near-infrared Spectroscopy
- ClinicalTrials.gov ID
- NCT02959008
- Acronym / sponsor ID
- 111
- Conditions
- Cerebral Blood Flow, Cerebral Perfusion Pressure
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Yu LiyunUniversity, hospital or other
- Study start
- Dec 2016
- Primary completion
- Dec 2018 (estimated)
- Study completion
- Dec 2019 (estimated)
- First posted
- 8 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.
Cerebral autoregulation can be explained by a tight coupling between oxygen supply and demand of the brain, and is essential to maintain a constant cerebral blood flow (CBF) in the context of changes in cerebral perfusion pressure. In this study, investigators use Near-infrared spectroscopy (NIRS) to monitor cerebral autoregulation.
Detailed description
Near-infrared spectroscopy (NIRS) is a noninvasive technology that real-time monitors cerebral tissue oxygenation index (TOI). Investigators use Near-infrared spectroscopy (NIRS) to monitor cerebral autoregulation of hypertensive participants and non-hypertensive participants.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| normal | – | Device: measure TOI and BPHuman without hypertension, diabetes, anemia, liver disease and kidney disease. The group will measure TOI and BP. |
| hypertension | – | Device: measure TOI and BPHuman only have hypertension, without diabetes, anemia, liver disease and kidney disease. Hypertension group will measure TOI and BP. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 1. adult 2. health people 3. people with hypertension
Key inclusion criteria (1 listed)
- health people, or people with hypertension
Key exclusion criteria (1 listed)
- diabetes, anemia, liver disease, kidney disease.
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 |
|---|---|---|
| measure TOI and BPBoth groups measure TOI and BP. | Device | hypertension, normal |
Primary outcome
range of cerebral autoregulation
Time frame: 30min
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Nov 2016.
- Individual participant dataSharing planned: No
Related trials for Cerebral Blood Flow
RecruitingObservational study
Studies of Blood Flow to the Brain During Thought
Healthy Volunteer
RecruitingObservational study
Association of Prophylactic Use of Stress Ulcer Drugs and Clinical Outcomes in Patients With Acute Anterior Circulation Thrombectomy
Acute Ischemic Stroke
Not yet recruitingObservational study
Multimodal MRI Assessment of Brain Fluid Circulation in Idiopathic Intracranial Hypertension
Idiopathic Intracranial Hypertension
Not yet recruitingObservational study
Heart and Brain Blood Flow in Obstructive Sleep Apnea
Obstructive Sleep Apnea (OSA)
Not yet recruitingObservational study
Brain-based Prediction of the Dying Duration in Humans After Withdrawal of Life Sustaining Therapies to Inform Donation After Circulatory Death
Organ Donation After Circulatory Death
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.
Xiaohong Wu principal investigator
Beijing Electric Power Hospital
Questions about this trial
What is this clinical trial studying?
An observational study of Cerebral Blood Flow and Cerebral Perfusion Pressure, run by Yu Liyun.
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: status not confirmed, as of the sponsor's last update on 16 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?
Contact Liyun Yu (13683217693, yu_li_yun@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
range of cerebral autoregulation (time frame: 30min). 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 16 Nov 2016.