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/NCT06036732</url>
    </required_header>
    <id_info>
      <org_study_id>E-72109855-604.01.01-7591</org_study_id>
      <nct_id>NCT06036732</nct_id>
    </id_info>
    <brief_title>A New Approach in Intensive Care Unit Consciousness Assessment: FIVE Score</brief_title>
    <official_title>The New Developed FIVE Score and Its Comparison With GCS and FOUR Scores Regarding Length of Hospital Stay Morbidity and Mortality in Neuro-intensive Care Patients. an Observational Prospective Study</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Istanbul University - Cerrahpasa (IUC)</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Istanbul University - Cerrahpasa (IUC)</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        1. The primary aim of this study is to investigate the correlation between the length of&#xD;
             ICU stay and a newly developed FIVE score in neuro-intensive care patients.&#xD;
  &#xD;
          2. The secondary objectives are to evaluate the impact of the FIVE score on hospital length&#xD;
             of stay, Modified Rankin Scale, and mortality, as well as to determine the correlation&#xD;
             between the GCS, FOUR, and FIVE scores&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Consciousness monitoring is crucial in neuro-intensive care. Despite the use of different&#xD;
        scoring systems to establish a common language among evaluators, the Glasgow Coma Scale (GCS)&#xD;
        remains the most widely used in clinical practice. In GCS evaluation, verbal response, motor&#xD;
        response, and eye response are assessed. Another scoring system, FOUR (Full Outline of&#xD;
        UnResponsiveness ) Score is similar to the Glasgow Coma Score (GCS). But it is designed to&#xD;
        provide a more comprehensive neurological assessment. The FOUR score evaluates four areas:&#xD;
        including eye opening, motor response, brainstem reflexes, and respiration, and assigns a&#xD;
        score for each area. A comprehensive education regarding those scores was given the intensive&#xD;
        care healthcare providers before the trial.&#xD;
  &#xD;
        In this study, the investigators developed the Full Intracranial Validity Evaluation (FIVE)&#xD;
        Score, by adding the mean arterial pressure and gag reflex components to the FOUR score. The&#xD;
        investigators believe that this new score, which can be used for clinical monitoring, may&#xD;
        offer an alternative to FOUR and GCS monitoring. According to this scoring system, in&#xD;
        addition to the criteria for the FOUR score, patients with a mean arterial pressure between&#xD;
        60-130mmHg receive 2 points; patients under inotropic support with a mean arterial pressure&#xD;
        between 60-130mmHg receive 1 point; patients with a mean arterial pressure below 60mmHg or&#xD;
        above 130mmHg receive 0 points. Additionally, for patients with infratentorial mass, the&#xD;
        investigators add the assessment of gag reflex in the calculation of the FIVE score. If the&#xD;
        reflex is absent, 0 points are given; if it is unilateral, 1 point is given, and if it is&#xD;
        preserved, 2 points are given.&#xD;
  &#xD;
        The demographic data, diagnoses, systemic comorbidities, the American Society of&#xD;
        Anaesthesiologists (ASA) score, the Charlson Comorbidity Index (CCI), and the APACHE II&#xD;
        scores of patients were recorded.&#xD;
  &#xD;
        The GCS, FOUR, and FIVE scores of the patients were recorded at neuro ICU admission, every 12&#xD;
        hours during neuro ICU follow-up period and discharge. In our clinic, GCS monitoring is&#xD;
        routinely performed hourly for every patient admitted to the ICU. For patients with a&#xD;
        decrease of two or more points in GCS score, FOUR and FIVE scores were re-evaluated and&#xD;
        recorded without waiting for the 12 hours. Besides this, the worst, the best and the mean&#xD;
        GCS, FOUR, and FIVE scores were recorded in the neuro ICU follow-up period. The assessment&#xD;
        count of the GCS, FOUR, and FIVE scores during clinical follow-up was recorded.&#xD;
  &#xD;
        The length of ICU and hospital stay were recorded. The Modified Rankin Scale of the patients&#xD;
        was recorded six months after ICU discharge.&#xD;
  &#xD;
        The primary aim of this study is to investigate the correlation between the length of ICU&#xD;
        stay and a newly developed FIVE score in neuro-intensive care patients. The secondary&#xD;
        objectives are to evaluate the impact of the FIVE score on length of hospital stay, Modified&#xD;
        Rankin Scale, and mortality, as well as to determine the correlation between the GCS, FOUR,&#xD;
        and FIVE scores.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">October 1, 2023</start_date>
    <completion_date type="Anticipated">February 25, 2024</completion_date>
    <primary_completion_date type="Anticipated">January 25, 2024</primary_completion_date>
    <study_type>Observational [Patient Registry]</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Case-Only</observational_model>
      <time_perspective>Prospective</time_perspective>
    </study_design_info>
    <target_duration>6 Months</target_duration>
    <primary_outcome>
      <measure>Change in FIVE Scores</measure>
      <time_frame>baseline, 12 hours intervals, up to an hour of ICU discharge</time_frame>
      <description>Full Intracranial Validity Evaluation, minimum value:0, maximum value: 20, higher scores mean a better situation</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Change in GKS Scores</measure>
      <time_frame>baseline, 12 hours intervals, up to an hour of ICU discharge</time_frame>
      <description>Glasgow Coma Score, minimum value:3, maximum value: 15, higher scores mean a better situation</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Modified Rankin Scale</measure>
      <time_frame>six months after ICU discharge</time_frame>
      <description>In scoring post-discharge morbidity six months after intensive care unit discharge, Modified Rankin Score is used. minimum value:0, maximum value:6, higher scores mean a worse outcome</description>
    </primary_outcome>
    <other_outcome>
      <measure>Length of stay in ICU</measure>
      <time_frame>From hospitalization to hospital discharge, estimated average = 10 days</time_frame>
      <description>Length of neuro ICU follow-up period</description>
    </other_outcome>
    <other_outcome>
      <measure>Length of stay in hospital</measure>
      <time_frame>From hospitalization to hospital discharge, estimated average = 10 days</time_frame>
      <description>Length of hospital follow-up period</description>
    </other_outcome>
    <enrollment type="Anticipated">223</enrollment>
    <condition>Postoperative Intracranial Hematoma</condition>
    <condition>Postoperative Intracranial Haemorrhage</condition>
    <condition>Supratentorial Cancer</condition>
    <condition>Infratentorial Neoplasms</condition>
    <condition>Arnold Chiari Malformation</condition>
    <condition>Subarachnoid Hemorrhage</condition>
    <condition>Traumatic Brain Injury</condition>
    <condition>Epilepsy, Temporal Lobe</condition>
    <condition>Cerebrovascular Event</condition>
    <condition>Intensive Care Neurological Disorder</condition>
    <condition>Coma</condition>
    <condition>Unconsciousness</condition>
    <condition>Assessment, Self</condition>
    <eligibility>
      <study_pop>
        <textblock>
          patients between the ages of 18 and 80, who were monitored in the Neurosurgical Intensive&#xD;
          Care Unit and had a history of ischemic or hemorrhagic stroke within the last 6 months,&#xD;
          underwent infratentorial craniotomy, supratentorial craniotomy, endoscopic surgery,&#xD;
          vascular surgery, epilepsy surgery, hydrocephalus surgery, or neurovascular intervention,&#xD;
          were included in the study&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  between the ages of 18 and 80&#xD;
  &#xD;
            -  who were monitored in the Neurosurgical Intensive Care Unit&#xD;
  &#xD;
            -  had a history of ischemic or hemorrhagic stroke within the last 6 months&#xD;
  &#xD;
            -  underwent infratentorial craniotomy&#xD;
  &#xD;
            -  supratentorial craniotomy&#xD;
  &#xD;
            -  endoscopic surgery&#xD;
  &#xD;
            -  vascular surgery&#xD;
  &#xD;
            -  epilepsy surgery&#xD;
  &#xD;
            -  hydrocephalus surgery&#xD;
  &#xD;
            -  neurovascular intervention&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  patients over 80 years of age&#xD;
  &#xD;
            -  under 18 years of age&#xD;
  &#xD;
            -  patients who were sedated&#xD;
  &#xD;
            -  patients who were administered neuromuscular blockers during intensive care follow-up&#xD;
  &#xD;
            -  patients with diagnosed psychiatric illness&#xD;
  &#xD;
            -  patients who were alcohol or drug addicts&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>80 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Ozlem Korkmaz Dilmen, MD</last_name>
      <role>Study Chair</role>
      <affiliation>Istanbul University - Cerrahpasa (IUC)</affiliation>
    </overall_official>
    <overall_official>
      <last_name>Yusuf Tunali, MD</last_name>
      <role>Study Director</role>
      <affiliation>Istanbul University - Cerrahpasa (IUC)</affiliation>
    </overall_official>
    <overall_official>
      <last_name>Fatma Eren Akcil, MD</last_name>
      <role>Study Director</role>
      <affiliation>Istanbul University - Cerrahpasa (IUC)</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Merve Tugba Ozfidan Donmez, MD</last_name>
      <phone>00905056444156</phone>
      <email>mtozfidann@gmail.com</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Ozlem Korkmaz Dilmen, MD</last_name>
      <phone>00905325801520</phone>
      <email>korkmazdilmen@gmail.com</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Istanbul University- Cerrahpasa(IUC)</name>
        <address>
          <city>Istanbul</city>
          <state>Fatih</state>
          <zip>34098</zip>
          <country>Turkey</country>
        </address>
      </facility>
      <contact>
        <last_name>Merve Tugba Ozfidan Donmez, MD</last_name>
        <phone>00905056444156</phone>
        <email>mtozfidann@gmail.com</email>
      </contact>
    </location>
    <location_countries>
      <country>Turkey</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>April 27, 2023</study_first_submitted>
    <study_first_submitted_qc>September 13, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 14, 2023</study_first_posted>
    <last_update_submitted>September 13, 2023</last_update_submitted>
    <last_update_submitted_qc>September 13, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 14, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Istanbul University - Cerrahpasa (IUC)</investigator_affiliation>
      <investigator_full_name>merve tugba ozfidan donmez</investigator_full_name>
      <investigator_title>medical doctor</investigator_title>
    </responsible_party>
    <keyword>FIVE Score</keyword>
    <keyword>FOUR Score</keyword>
    <keyword>GCS</keyword>
    <keyword>Modified Rankin Score</keyword>
    <keyword>Neuro-ICU</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Infratentorial Neoplasms</mesh_term>
      <mesh_term>Supratentorial Neoplasms</mesh_term>
      <mesh_term>Brain Injuries</mesh_term>
      <mesh_term>Brain Injuries, Traumatic</mesh_term>
      <mesh_term>Subarachnoid Hemorrhage</mesh_term>
      <mesh_term>Intracranial Hemorrhages</mesh_term>
      <mesh_term>Nervous System Diseases</mesh_term>
      <mesh_term>Arnold-Chiari Malformation</mesh_term>
      <mesh_term>Epilepsy, Temporal Lobe</mesh_term>
      <mesh_term>Unconsciousness</mesh_term>
      <mesh_term>Hemorrhage</mesh_term>
      <mesh_term>Hematoma</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>Undecided</sharing_ipd>
      <ipd_description>Glasgow Coma Scale (GCS) and Four/Five Scores, along with the highest, lowest, and average scores, discharge scores, Modified Rankin Scores at 6 months post-discharge, and length of stay information measured upon admission to the intensive care unit will be shared.</ipd_description>
    </patient_data>
    <!-- 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/NCT06036732
  org study id: E-72109855-604.01.01-7591
  nct id: NCT06036732
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  1. The primary aim of this study is to investigate the correlation between the length of
             ICU stay and a newly developed FIVE score in neuro-intensive care patients.
  
          2. The secondary objectives are to evaluate the impact of the FIVE score on hospital length
             of stay, Modified Rankin Scale, and mortality, as well as to determine the correlation
             between the GCS, FOUR, and FIVE scores
  Consciousness monitoring is crucial in neuro-intensive care. Despite the use of different
        scoring systems to establish a common language among evaluators, the Glasgow Coma Scale (GCS)
        remains the most widely used in clinical practice. In GCS evaluation, verbal response, motor
        response, and eye response are assessed. Another scoring system, FOUR (Full Outline of
        UnResponsiveness ) Score is similar to the Glasgow Coma Score (GCS). But it is designed to
        provide a more comprehensive neurological assessment. The FOUR score evaluates four areas:
        including eye opening, motor response, brainstem reflexes, and respiration, and assigns a
        score for each area. A comprehensive education regarding those scores was given the intensive
        care healthcare providers before the trial.
  
        In this study, the investigators developed the Full Intracranial Validity Evaluation (FIVE)
        Score, by adding the mean arterial pressure and gag reflex components to the FOUR score. The
        investigators believe that this new score, which can be used for clinical monitoring, may
        offer an alternative to FOUR and GCS monitoring. According to this scoring system, in
        addition to the criteria for the FOUR score, patients with a mean arterial pressure between
        60-130mmHg receive 2 points; patients under inotropic support with a mean arterial pressure
        between 60-130mmHg receive 1 point; patients with a mean arterial pressure below 60mmHg or
        above 130mmHg receive 0 points. Additionally, for patients with infratentorial mass, the
        investigators add the assessment of gag reflex in the calculation of the FIVE score. If the
        reflex is absent, 0 points are given; if it is unilateral, 1 point is given, and if it is
        preserved, 2 points are given.
  
        The demographic data, diagnoses, systemic comorbidities, the American Society of
        Anaesthesiologists (ASA) score, the Charlson Comorbidity Index (CCI), and the APACHE II
        scores of patients were recorded.
  
        The GCS, FOUR, and FIVE scores of the patients were recorded at neuro ICU admission, every 12
        hours during neuro ICU follow-up period and discharge. In our clinic, GCS monitoring is
        routinely performed hourly for every patient admitted to the ICU. For patients with a
        decrease of two or more points in GCS score, FOUR and FIVE scores were re-evaluated and
        recorded without waiting for the 12 hours. Besides this, the worst, the best and the mean
        GCS, FOUR, and FIVE scores were recorded in the neuro ICU follow-up period. The assessment
        count of the GCS, FOUR, and FIVE scores during clinical follow-up was recorded.
  
        The length of ICU and hospital stay were recorded. The Modified Rankin Scale of the patients
        was recorded six months after ICU discharge.
  
        The primary aim of this study is to investigate the correlation between the length of ICU
        stay and a newly developed FIVE score in neuro-intensive care patients. The secondary
        objectives are to evaluate the impact of the FIVE score on length of hospital stay, Modified
        Rankin Scale, and mortality, as well as to determine the correlation between the GCS, FOUR,
        and FIVE scores.
  observational model: Case-Only
  time perspective: Prospective
  measure: Change in FIVE Scores
  time frame: baseline, 12 hours intervals, up to an hour of ICU discharge
  description: Full Intracranial Validity Evaluation, minimum value:0, maximum value: 20, higher scores mean a better situation
  measure: Change in GKS Scores
  time frame: baseline, 12 hours intervals, up to an hour of ICU discharge
  description: Glasgow Coma Score, minimum value:3, maximum value: 15, higher scores mean a better situation
  measure: Modified Rankin Scale
  time frame: six months after ICU discharge
  description: In scoring post-discharge morbidity six months after intensive care unit discharge, Modified Rankin Score is used. minimum value:0, maximum value:6, higher scores mean a worse outcome
  measure: Length of stay in ICU
  time frame: From hospitalization to hospital discharge, estimated average = 10 days
  description: Length of neuro ICU follow-up period
  measure: Length of stay in hospital
  time frame: From hospitalization to hospital discharge, estimated average = 10 days
  description: Length of hospital follow-up period
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 80 Years
  healthy volunteers: No
  last name: Ozlem Korkmaz Dilmen, MD
  role: Study Chair
  affiliation: Istanbul University - Cerrahpasa (IUC)
  last name: Yusuf Tunali, MD
  role: Study Director
  affiliation: Istanbul University - Cerrahpasa (IUC)
  last name: Fatma Eren Akcil, MD
  role: Study Director
  affiliation: Istanbul University - Cerrahpasa (IUC)
  last name: Merve Tugba Ozfidan Donmez, MD
  phone: 00905056444156
  email: mtozfidann@gmail.com
  last name: Ozlem Korkmaz Dilmen, MD
  phone: 00905325801520
  email: korkmazdilmen@gmail.com
  facility: 
  contact: 
  country: Turkey
  responsible party type: Principal Investigator
  investigator affiliation: Istanbul University - Cerrahpasa (IUC)
  investigator full name: merve tugba ozfidan donmez
  investigator title: medical doctor
  mesh term: Infratentorial Neoplasms
  mesh term: Supratentorial Neoplasms
  mesh term: Brain Injuries
  mesh term: Brain Injuries, Traumatic
  mesh term: Subarachnoid Hemorrhage
  mesh term: Intracranial Hemorrhages
  mesh term: Nervous System Diseases
  mesh term: Arnold-Chiari Malformation
  mesh term: Epilepsy, Temporal Lobe
  mesh term: Unconsciousness
  mesh term: Hemorrhage
  mesh term: Hematoma
  sharing ipd: Undecided
  ipd description: Glasgow Coma Scale (GCS) and Four/Five Scores, along with the highest, lowest, and average scores, discharge scores, Modified Rankin Scores at 6 months post-discharge, and length of stay information measured upon admission to the intensive care unit will be shared.