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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06016751
Other study ID # YLong
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 1, 2021
Est. completion date January 1, 2022

Study information

Verified date August 2023
Source Peking Union Medical College Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Completed
Enrollment 30
Est. completion date January 1, 2022
Est. primary completion date January 1, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 ß-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 Design


Locations

Country Name City State
China Wei Du Beijing Beijing

Sponsors (1)

Lead Sponsor Collaborator
Peking Union Medical College Hospital

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary intracranial blood flow Mean intracranial middle cerebral artery blood flow velocity and pulsatility index measured using ultrasound Doppler in enrolled patients. Day 1,Day 3,Day 5
Primary Paroxysmal sympathetic excitation Use of the Paroxysmal Sympathetic Nerve Score to assess paroxysmal sympathoexcitatory performance in patients. Day 1,Day 3,Day 5
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