- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06016751
Relationship Between Intracranial Blood Flow and Peripheral Perfusion in Patients With Craniocerebral Injury
August 23, 2023 updated by: Peking Union Medical College Hospital
Relationship Between Intracranial Blood Flow and Peripheral Perfusion in Patients With Craniocerebral Injury Assessed by Doppler Ultrasound and Prognostic Assessment
Neurocritical care is a major branch in the field of critical care medicine, and more than 50% of the neurocritical care patients in the Tibet Autonomous Region People's Hospital (TARPH) are in neurocritical care, of which cranial damage accounts for about 30%, and paroxysmal sympathetic hyperexcitability syndrome (PSH) after traumatic brain injury(TBI)is a common complication, which affects the cardiorespiratory and cerebral functions to varying degrees, and optimizing the cerebral perfusion and oxygenation supply is the key point in the treatment of TIB, and the maintenance of the cerebral homeostasis and the functional homeostasis is currently an international hotspot for treatment.
Maintaining cerebral homeostasis and body function homeostasis is an international hotspot in the treatment of TIB.
This study intends to elaborate on the relationship between PSH and Intracranial blood flow in patients with TBI, as well as the effect of anti-stress treatment on Intracranial blood flow.
Implementation Patients with brain injury admitted to our department from January 2021 to January 2022 were included.
Non-invasive transcranial Doppler ultrasound was applied to measure cerebral blood flow, non-invasive local cerebral oxygen saturation monitor to measure local cerebral oxygen saturation, and an electroencephalography bispectrometer to measure BIS score to quantify the depth of sedation during the experimental process.
Bedside ultrasound monitored the right heart function and lung water status, and the data of each monitoring index were monitored and recorded throughout the whole process, and the relationship between concomitant PSH and Intracranial blood flow in TBI patients was found according to the statistical analysis.
Ultimately, to achieve the control of TBI complications and improve patient rescue.
To expect to achieve the purpose of improving the prognosis of TBI patients.
Study Overview
Status
Completed
Conditions
Study Type
Observational
Enrollment (Actual)
30
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Beijing
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Beijing, Beijing, China
- Wei Du
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Sampling Method
Probability Sample
Study Population
Definite craniocerebral injury, surgically treated and transferred to ICU.
Description
Inclusion Criteria:
- Craniocerebral injury patients;
- The middle cerebral artery blood flow spectrum can be clearly displayed with a bedside TCD;
Exclusion Criteria:
- Age Under 18 years;
- history of cardiovascular disease such as coronary artery disease, heart failure, or atrial fibrillation;
- presence of severe valvular disease or ejection fraction (EF) <30%;
- chronic lung disease;
- chronic liver failure or renal insufficiency;
- persons with co-morbidities of malignant neoplasms;
- persons who had co-morbidities with acute and chronic infectious diseases prior to craniocerebral injuries;
- women who were pregnant and breastfeeding;
- history of psychiatric disorders;
- history of drug abuse or alcohol misuse;
- history of β-blockers;
- co-morbidities with spinal cord injuries; and persons who had died or been discharged from hospital within 1 week of hospitalization or who had not been able to obtain a clear image with ultrasonography.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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cranial damage
Our study was a prospective observational study which included only a group of patients who were diagnosed with acute craniocerebral injury.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
intracranial blood flow
Time Frame: Day 1,Day 3,Day 5
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Mean intracranial middle cerebral artery blood flow velocity and pulsatility index measured using ultrasound Doppler in enrolled patients.
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Day 1,Day 3,Day 5
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Paroxysmal sympathetic excitation
Time Frame: Day 1,Day 3,Day 5
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Use of the Paroxysmal Sympathetic Nerve Score to assess paroxysmal sympathoexcitatory performance in patients.
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Day 1,Day 3,Day 5
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 1, 2021
Primary Completion (Actual)
January 1, 2022
Study Completion (Actual)
January 1, 2022
Study Registration Dates
First Submitted
July 19, 2023
First Submitted That Met QC Criteria
August 23, 2023
First Posted (Actual)
August 30, 2023
Study Record Updates
Last Update Posted (Actual)
August 30, 2023
Last Update Submitted That Met QC Criteria
August 23, 2023
Last Verified
August 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- YLong
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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