xml: <clinical_study>
    <!-- This xml conforms to an XML Schema at:
      https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
    <required_header>
      <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
      <link_text>Link to the current ClinicalTrials.gov record.</link_text>
      <url>https://clinicaltrials.gov/ct2/show/NCT06016751</url>
    </required_header>
    <id_info>
      <org_study_id>YLong</org_study_id>
      <nct_id>NCT06016751</nct_id>
    </id_info>
    <brief_title>Relationship Between Intracranial Blood Flow and Peripheral Perfusion in Patients With Craniocerebral Injury</brief_title>
    <official_title>Relationship Between Intracranial Blood Flow and Peripheral Perfusion in Patients With Craniocerebral Injury Assessed by Doppler Ultrasound and Prognostic Assessment</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Peking Union Medical College Hospital</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Peking Union Medical College Hospital</source>
    <oversight_info>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        Neurocritical care is a major branch in the field of critical care medicine, and more than&#xD;
        50% of the neurocritical care patients in the Tibet Autonomous Region People's Hospital&#xD;
        (TARPH) are in neurocritical care, of which cranial damage accounts for about 30%, and&#xD;
        paroxysmal sympathetic hyperexcitability syndrome (PSH) after traumatic brain injury（TBI）is a&#xD;
        common complication, which affects the cardiorespiratory and cerebral functions to varying&#xD;
        degrees, and optimizing the cerebral perfusion and oxygenation supply is the key point in the&#xD;
        treatment of TIB, and the maintenance of the cerebral homeostasis and the functional&#xD;
        homeostasis is currently an international hotspot for treatment. Maintaining cerebral&#xD;
        homeostasis and body function homeostasis is an international hotspot in the treatment of&#xD;
        TIB. This study intends to elaborate on the relationship between PSH and Intracranial blood&#xD;
        flow in patients with TBI, as well as the effect of anti-stress treatment on Intracranial&#xD;
        blood flow. Implementation Patients with brain injury admitted to our department from January&#xD;
        2021 to January 2022 were included. Non-invasive transcranial Doppler ultrasound was applied&#xD;
        to measure cerebral blood flow, non-invasive local cerebral oxygen saturation monitor to&#xD;
        measure local cerebral oxygen saturation, and an electroencephalography bispectrometer to&#xD;
        measure BIS score to quantify the depth of sedation during the experimental process. Bedside&#xD;
        ultrasound monitored the right heart function and lung water status, and the data of each&#xD;
        monitoring index were monitored and recorded throughout the whole process, and the&#xD;
        relationship between concomitant PSH and Intracranial blood flow in TBI patients was found&#xD;
        according to the statistical analysis. Ultimately, to achieve the control of TBI&#xD;
        complications and improve patient rescue. To expect to achieve the purpose of improving the&#xD;
        prognosis of TBI patients.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">January 1, 2021</start_date>
    <completion_date type="Actual">January 1, 2022</completion_date>
    <primary_completion_date type="Actual">January 1, 2022</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Cohort</observational_model>
      <time_perspective>Prospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>intracranial blood flow</measure>
      <time_frame>Day 1,Day 3,Day 5</time_frame>
      <description>Mean intracranial middle cerebral artery blood flow velocity and pulsatility index measured using ultrasound Doppler in enrolled patients.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Paroxysmal sympathetic excitation</measure>
      <time_frame>Day 1,Day 3,Day 5</time_frame>
      <description>Use of the Paroxysmal Sympathetic Nerve Score to assess paroxysmal sympathoexcitatory performance in patients.</description>
    </primary_outcome>
    <number_of_groups>1</number_of_groups>
    <enrollment type="Actual">30</enrollment>
    <condition>Brain-injury</condition>
    <condition>Intracranial; Blood Vessel, Injury</condition>
    <arm_group>
      <arm_group_label>cranial damage</arm_group_label>
      <description>Our study was a prospective observational study which included only a group of patients who were diagnosed with acute craniocerebral injury.</description>
    </arm_group>
    <eligibility>
      <study_pop>
        <textblock>
          Definite craniocerebral injury, surgically treated and transferred to ICU.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Craniocerebral injury patients;&#xD;
  &#xD;
            -  The middle cerebral artery blood flow spectrum can be clearly displayed with a bedside&#xD;
               TCD;&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Age Under 18 years;&#xD;
  &#xD;
            -  history of cardiovascular disease such as coronary artery disease, heart failure, or&#xD;
               atrial fibrillation;&#xD;
  &#xD;
            -  presence of severe valvular disease or ejection fraction (EF) &lt;30%;&#xD;
  &#xD;
            -  chronic lung disease;&#xD;
  &#xD;
            -  chronic liver failure or renal insufficiency;&#xD;
  &#xD;
            -  persons with co-morbidities of malignant neoplasms;&#xD;
  &#xD;
            -  persons who had co-morbidities with acute and chronic infectious diseases prior to&#xD;
               craniocerebral injuries;&#xD;
  &#xD;
            -  women who were pregnant and breastfeeding;&#xD;
  &#xD;
            -  history of psychiatric disorders;&#xD;
  &#xD;
            -  history of drug abuse or alcohol misuse;&#xD;
  &#xD;
            -  history of β-blockers;&#xD;
  &#xD;
            -  co-morbidities with spinal cord injuries; and persons who had died or been discharged&#xD;
               from hospital within 1 week of hospitalization or who had not been able to obtain a&#xD;
               clear image with ultrasonography.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <location>
      <facility>
        <name>Wei Du</name>
        <address>
          <city>Beijing</city>
          <state>Beijing</state>
          <country>China</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>China</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 19, 2023</study_first_submitted>
    <study_first_submitted_qc>August 23, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 30, 2023</study_first_posted>
    <last_update_submitted>August 23, 2023</last_update_submitted>
    <last_update_submitted_qc>August 23, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 30, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Brain Injuries</mesh_term>
      <mesh_term>Craniocerebral Trauma</mesh_term>
      <mesh_term>Wounds and Injuries</mesh_term>
    </condition_browse>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: download date: ClinicalTrials.gov processed this data on September 20, 2023
  link text: Link to the current ClinicalTrials.gov record.
  url: https://clinicaltrials.gov/ct2/show/NCT06016751
  org study id: YLong
  nct id: NCT06016751
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  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.
  observational model: Cohort
  time perspective: Prospective
  measure: intracranial blood flow
  time frame: Day 1,Day 3,Day 5
  description: Mean intracranial middle cerebral artery blood flow velocity and pulsatility index measured using ultrasound Doppler in enrolled patients.
  measure: Paroxysmal sympathetic excitation
  time frame: Day 1,Day 3,Day 5
  description: Use of the Paroxysmal Sympathetic Nerve Score to assess paroxysmal sympathoexcitatory performance in patients.
  arm group label: cranial damage
  description: Our study was a prospective observational study which included only a group of patients who were diagnosed with acute craniocerebral injury.
  study pop: 
  sampling method: Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  facility: 
  country: China
  responsible party type: Sponsor
  mesh term: Brain Injuries
  mesh term: Craniocerebral Trauma
  mesh term: Wounds and Injuries