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/NCT05969483</url>
    </required_header>
    <id_info>
      <org_study_id>AOP2549</org_study_id>
      <nct_id>NCT05969483</nct_id>
    </id_info>
    <brief_title>Validation of a Processed EEG Device for Monitoring Sedation in PICU</brief_title>
    <official_title>Validation of a Processed EEG Device (pEEG, Masimo Sedline®) as a Monitoring Tool for the Analgosedation Level in Mechanically Ventilated Critically Ill Children</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Azienda Ospedaliera di Padova</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Azienda Ospedaliera di Padova</source>
    <oversight_info>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>Yes</is_fda_regulated_device>
      <is_unapproved_device>Yes</is_unapproved_device>
      <is_us_export>No</is_us_export>
    </oversight_info>
    <brief_summary>
      <textblock>
        The goal of this prospective observational study is to validate pEEG as a monitoring tool for&#xD;
        the analgosedation level in mechanically-ventilated critically ill children, receiving or&#xD;
        not-receiving NMBAs. The main question aims to answer is to measure the strength of agreement&#xD;
        between pEEG score and Comfort Behavioural Scale (CBS) (goal standard).&#xD;
  &#xD;
        Participants will be monitored with pEEG and CBS evaluated during PICU admission. paralysis&#xD;
        holiday) by a specialized PICU nurse and by a critical-care expert physician, blinded to each&#xD;
        other.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Rationale: The existence of a strong agreement between the two scores will allow us to&#xD;
        consider the use of Masimo Sedline® PSI in our routine practice as an additional tool to&#xD;
        monitor the analgosedation level of mechanically ventilated critically ill patients, as well&#xD;
        as the main tool for chemically paralyzed patients.The final goal of this project is to&#xD;
        validate the Masimo Sedline® as a monitoring tool for the analgosedation level in&#xD;
        mechanically-ventilated critically ill children, receiving or not-receiving NMBAs.&#xD;
  &#xD;
        Specific Aim. To evaluate the strength of agreement between CBS and the Masimo Sedline® PSI&#xD;
        in children.&#xD;
  &#xD;
        Design: prospective cohort study including all consecutive mechanically ventilated patients&#xD;
        receivinganalgosedation admitted to a tertiary-care PICU.&#xD;
  &#xD;
        Setting: Tertiary-care Center PICU (Padova University Hospital, Italy). Partecipants: all&#xD;
        consecutive patients who will receive mechanical ventilation and consequently analgosedation&#xD;
        admitted to our PICU during the study period. Both patients receiving NMBAs and patient not&#xD;
        receiving NMBAs will be included (patients with NMBA will be evaluated during a paralysis&#xD;
        holiday). Exclusion criteria: patient with skin lesions or other significant traumatic&#xD;
        lesions in the area where the Masimo Sedline® sensor need to be applied.&#xD;
  &#xD;
        Exposure: All patients will be exposed to the Masimo Sedline® sensor. Its pEEG scores,&#xD;
        including the PSI, will be registered by the patient primary nurse every 4 hours for the&#xD;
        first 5 days of ventilation. At the same time, CBS will be evaluated by a specialized PICU&#xD;
        nurse and by a critical-care expert physician, blinded to each other. In case of CBS&#xD;
        discordance between the two operators, a mean will be used for data analysis. In case of&#xD;
        chemically paralyzed patients, a paralysis holiday will be performed when clinically possible&#xD;
        (ideally twice a day). A CBS will be assessed when the paralytic agents will be considered&#xD;
        washed out, i.e. when the patient starts triggering at the ventilator and the EMG index&#xD;
        starts showing muscular activity. The patient's analgosedation strategy and analgosedation&#xD;
        protocol will not be standardized but will be decided by the treating physician based on the&#xD;
        international recommendations.&#xD;
  &#xD;
        Main outcome and measures: To evaluate the strength of agreement between the Masimo Sedline®&#xD;
        PSI (exposure) and the CBS in mechanically in mechanically ventilated children, adequately or&#xD;
        inadequately sedated, and in patients receiving NMBAs (during paralysis holiday).&#xD;
  &#xD;
        Analytical plan: Descriptive statistics will be used to describe patients' demographic and&#xD;
        clinical characteristics, as well as patient-related clinical outcomes. PSI and CBS will be&#xD;
        tested for agreement using K statistics separately in patients with adequate sedation (CBS&#xD;
        11-22), inadequate sedation (CBS &lt;11 or &gt;22), and in patients receiving NMBAs. Multiple&#xD;
        sensitivity analyses will be also performed in different subcohort of patients, including&#xD;
        neonates, patients with seizures, as well as for different drugs. As an additional analysis,&#xD;
        the use of a composite score including the EMG index (i.e. muscular activity) and the EEG&#xD;
        suppression ratio (measure of EGG suppression events as index of oversedation) will be&#xD;
        included.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">October 1, 2022</start_date>
    <completion_date type="Anticipated">September 2024</completion_date>
    <primary_completion_date type="Anticipated">March 2024</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>agreement between PSI (exposure) and CBS scale the CBS</measure>
      <time_frame>T1 (after 4 hours of ventilation)</time_frame>
      <description>grade of agreement (Kappa of Cohen)</description>
    </primary_outcome>
    <primary_outcome>
      <measure>agreement between PSI (exposure) and CBS scale</measure>
      <time_frame>T1 (after 8 hours of ventilation)</time_frame>
      <description>grade of agreement (Kappa of Cohen)</description>
    </primary_outcome>
    <number_of_groups>1</number_of_groups>
    <enrollment type="Anticipated">150</enrollment>
    <condition>Sedation Complication</condition>
    <arm_group>
      <arm_group_label>sedated and ventilated pediatric critical care patients</arm_group_label>
      <description>All sedated and ventilated critically ill patients will be exposed to the Masimo Sedline® sensor. Its pEEG scores, including the PSI, will be registered by the patient primary nurse every 4 hours for the first 5 days of ventilation. At the same time, CBS will be evaluated by a specialized PICU nurse and by a critical-care expert physician, blinded to each other. In case of chemically paralyzed patients, a paralysis holiday will be performed when clinically possible . A CBS will be assessed when the paralytic agents will be considered washed out. The patient's analgosedation strategy and analgosedation protocol will not be standardized but will be decided by the treating physician based on the international recommendations.</description>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>pEEG monitoring</intervention_name>
      <description>pEEG monitoring during PICU admission</description>
      <arm_group_label>sedated and ventilated pediatric critical care patients</arm_group_label>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          Pediatric patients admitted in PICU who undergone sedation and mechanical (invasive and non&#xD;
          invasive) ventilation&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
          - sedated and ventilated patients admitted in PICU&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  skin lesions&#xD;
  &#xD;
            -  significant traumatic lesions in the area where the Masimo Sedline® sensor need to be&#xD;
               applied.&#xD;
        </textblock>
      </criteria>
      <gender>Female</gender>
      <minimum_age>1 Day</minimum_age>
      <maximum_age>18 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>angela amigoni, MD</last_name>
      <role>Principal Investigator</role>
      <affiliation>University Hospital of Padova</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>angela amigoni, MD</last_name>
      <phone>+39 339 8333765</phone>
      <email>angela.amigoni@aopd.veneto.it</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>anna tessari</last_name>
      <phone>+ 39 3497804876</phone>
      <email>anna.tessari@aopd.veneto.it</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>University Hospital of Padova</name>
        <address>
          <city>Padova</city>
          <zip>35128</zip>
          <country>Italy</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>angela amigoni, MD</last_name>
        <phone>+39 339 8333765</phone>
        <email>angela.amigoni@aopd.veneto.it</email>
      </contact>
      <contact_backup>
        <last_name>anna tessari, MD</last_name>
        <phone>+39 349 7804876</phone>
        <email>anna.tessari@aopd.veneto.it</email>
      </contact_backup>
      <investigator>
        <last_name>francesca sperotto, PhD</last_name>
        <role>Sub-Investigator</role>
      </investigator>
      <investigator>
        <last_name>marco daverio, MD</last_name>
        <role>Sub-Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>Italy</country>
    </location_countries>
    <results_reference>
      <citation>Harris J, Ramelet AS, van Dijk M, Pokorna P, Wielenga J, Tume L, Tibboel D, Ista E. Clinical recommendations for pain, sedation, withdrawal and delirium assessment in critically ill infants and children: an ESPNIC position statement for healthcare professionals. Intensive Care Med. 2016 Jun;42(6):972-86. doi: 10.1007/s00134-016-4344-1. Epub 2016 Apr 15.</citation>
      <PMID>27084344</PMID>
    </results_reference>
    <results_reference>
      <citation>Amigoni A, Mozzo E, Brugnaro L, Gentilomo C, Stritoni V, Michelin E, Pettenazzo A. Assessing sedation in a pediatric intensive care unit using Comfort Behavioural Scale and Bispectral Index: these tools are different. Minerva Anestesiol. 2012 Mar;78(3):322-9.</citation>
      <PMID>22127309</PMID>
    </results_reference>
    <results_reference>
      <citation>Twite MD, Zuk J, Gralla J, Friesen RH. Correlation of the Bispectral Index Monitor with the COMFORT scale in the pediatric intensive care unit. Pediatr Crit Care Med. 2005 Nov;6(6):648-53; quiz 654.</citation>
      <PMID>16276329</PMID>
    </results_reference>
    <results_reference>
      <citation>Tobias JD, Grindstaff R. Bispectral index monitoring during the administration of neuromuscular blocking agents in the pediatric intensive care unit patient. J Intensive Care Med. 2005 Jul-Aug;20(4):233-7. doi: 10.1177/0885066605276806.</citation>
      <PMID>16061906</PMID>
    </results_reference>
    <results_reference>
      <citation>Christenson C, Martinez-Vazquez P, Breidenstein M, Farhang B, Mathews J, Melia U, Jensen EW, Mathews D. Comparison of the Conox (qCON) and Sedline (PSI) depth of anaesthesia indices to predict the hypnotic effect during desflurane general anaesthesia with ketamine. J Clin Monit Comput. 2021 Dec;35(6):1421-1428. doi: 10.1007/s10877-020-00619-3. Epub 2020 Nov 19.</citation>
      <PMID>33211251</PMID>
    </results_reference>
    <results_reference>
      <citation>Ista E, van Dijk M, Tibboel D, de Hoog M. Assessment of sedation levels in pediatric intensive care patients can be improved by using the COMFORT &quot;behavior&quot; scale. Pediatr Crit Care Med. 2005 Jan;6(1):58-63. doi: 10.1097/01.PCC.0000149318.40279.1A.</citation>
      <PMID>15636661</PMID>
    </results_reference>
    <results_reference>
      <citation>Smith HAB, Besunder JB, Betters KA, Johnson PN, Srinivasan V, Stormorken A, Farrington E, Golianu B, Godshall AJ, Acinelli L, Almgren C, Bailey CH, Boyd JM, Cisco MJ, Damian M, deAlmeida ML, Fehr J, Fenton KE, Gilliland F, Grant MJC, Howell J, Ruggles CA, Simone S, Su F, Sullivan JE, Tegtmeyer K, Traube C, Williams S, Berkenbosch JW. 2022 Society of Critical Care Medicine Clinical Practice Guidelines on Prevention and Management of Pain, Agitation, Neuromuscular Blockade, and Delirium in Critically Ill Pediatric Patients With Consideration of the ICU Environment and Early Mobility. Pediatr Crit Care Med. 2022 Feb 1;23(2):e74-e110. doi: 10.1097/PCC.0000000000002873.</citation>
      <PMID>35119438</PMID>
    </results_reference>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>May 20, 2023</study_first_submitted>
    <study_first_submitted_qc>July 23, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 1, 2023</study_first_posted>
    <last_update_submitted>July 23, 2023</last_update_submitted>
    <last_update_submitted_qc>July 23, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 1, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Azienda Ospedaliera di Padova</investigator_affiliation>
      <investigator_full_name>angela amigoni</investigator_full_name>
      <investigator_title>Director</investigator_title>
    </responsible_party>
    <keyword>sedation</keyword>
    <keyword>pediatric intensive care</keyword>
    <keyword>monitoring</keyword>
    <patient_data>
      <sharing_ipd>Undecided</sharing_ipd>
    </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/NCT05969483
  org study id: AOP2549
  nct id: NCT05969483
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: Yes
  is unapproved device: Yes
  is us export: No
  The goal of this prospective observational study is to validate pEEG as a monitoring tool for
        the analgosedation level in mechanically-ventilated critically ill children, receiving or
        not-receiving NMBAs. The main question aims to answer is to measure the strength of agreement
        between pEEG score and Comfort Behavioural Scale (CBS) (goal standard).
  
        Participants will be monitored with pEEG and CBS evaluated during PICU admission. paralysis
        holiday) by a specialized PICU nurse and by a critical-care expert physician, blinded to each
        other.
  Rationale: The existence of a strong agreement between the two scores will allow us to
        consider the use of Masimo Sedline® PSI in our routine practice as an additional tool to
        monitor the analgosedation level of mechanically ventilated critically ill patients, as well
        as the main tool for chemically paralyzed patients.The final goal of this project is to
        validate the Masimo Sedline® as a monitoring tool for the analgosedation level in
        mechanically-ventilated critically ill children, receiving or not-receiving NMBAs.
  
        Specific Aim. To evaluate the strength of agreement between CBS and the Masimo Sedline® PSI
        in children.
  
        Design: prospective cohort study including all consecutive mechanically ventilated patients
        receivinganalgosedation admitted to a tertiary-care PICU.
  
        Setting: Tertiary-care Center PICU (Padova University Hospital, Italy). Partecipants: all
        consecutive patients who will receive mechanical ventilation and consequently analgosedation
        admitted to our PICU during the study period. Both patients receiving NMBAs and patient not
        receiving NMBAs will be included (patients with NMBA will be evaluated during a paralysis
        holiday). Exclusion criteria: patient with skin lesions or other significant traumatic
        lesions in the area where the Masimo Sedline® sensor need to be applied.
  
        Exposure: All patients will be exposed to the Masimo Sedline® sensor. Its pEEG scores,
        including the PSI, will be registered by the patient primary nurse every 4 hours for the
        first 5 days of ventilation. At the same time, CBS will be evaluated by a specialized PICU
        nurse and by a critical-care expert physician, blinded to each other. In case of CBS
        discordance between the two operators, a mean will be used for data analysis. In case of
        chemically paralyzed patients, a paralysis holiday will be performed when clinically possible
        (ideally twice a day). A CBS will be assessed when the paralytic agents will be considered
        washed out, i.e. when the patient starts triggering at the ventilator and the EMG index
        starts showing muscular activity. The patient's analgosedation strategy and analgosedation
        protocol will not be standardized but will be decided by the treating physician based on the
        international recommendations.
  
        Main outcome and measures: To evaluate the strength of agreement between the Masimo Sedline®
        PSI (exposure) and the CBS in mechanically in mechanically ventilated children, adequately or
        inadequately sedated, and in patients receiving NMBAs (during paralysis holiday).
  
        Analytical plan: Descriptive statistics will be used to describe patients' demographic and
        clinical characteristics, as well as patient-related clinical outcomes. PSI and CBS will be
        tested for agreement using K statistics separately in patients with adequate sedation (CBS
        11-22), inadequate sedation (CBS <11 or >22), and in patients receiving NMBAs. Multiple
        sensitivity analyses will be also performed in different subcohort of patients, including
        neonates, patients with seizures, as well as for different drugs. As an additional analysis,
        the use of a composite score including the EMG index (i.e. muscular activity) and the EEG
        suppression ratio (measure of EGG suppression events as index of oversedation) will be
        included.
  observational model: Cohort
  time perspective: Prospective
  measure: agreement between PSI (exposure) and CBS scale the CBS
  time frame: T1 (after 4 hours of ventilation)
  description: grade of agreement (Kappa of Cohen)
  measure: agreement between PSI (exposure) and CBS scale
  time frame: T1 (after 8 hours of ventilation)
  description: grade of agreement (Kappa of Cohen)
  arm group label: sedated and ventilated pediatric critical care patients
  description: All sedated and ventilated critically ill patients will be exposed to the Masimo Sedline® sensor. Its pEEG scores, including the PSI, will be registered by the patient primary nurse every 4 hours for the first 5 days of ventilation. At the same time, CBS will be evaluated by a specialized PICU nurse and by a critical-care expert physician, blinded to each other. In case of chemically paralyzed patients, a paralysis holiday will be performed when clinically possible . A CBS will be assessed when the paralytic agents will be considered washed out. The patient's analgosedation strategy and analgosedation protocol will not be standardized but will be decided by the treating physician based on the international recommendations.
  intervention type: Device
  intervention name: pEEG monitoring
  description: pEEG monitoring during PICU admission
  arm group label: sedated and ventilated pediatric critical care patients
  study pop: 
  sampling method: Probability Sample
  criteria: 
  gender: Female
  minimum age: 1 Day
  maximum age: 18 Years
  healthy volunteers: No
  last name: angela amigoni, MD
  role: Principal Investigator
  affiliation: University Hospital of Padova
  last name: angela amigoni, MD
  phone: +39 339 8333765
  email: angela.amigoni@aopd.veneto.it
  last name: anna tessari
  phone: + 39 3497804876
  email: anna.tessari@aopd.veneto.it
  facility: 
  status: Recruiting
  contact: 
  contact backup: 
  investigator: 
  investigator: 
  country: Italy
  citation: Harris J, Ramelet AS, van Dijk M, Pokorna P, Wielenga J, Tume L, Tibboel D, Ista E. Clinical recommendations for pain, sedation, withdrawal and delirium assessment in critically ill infants and children: an ESPNIC position statement for healthcare professionals. Intensive Care Med. 2016 Jun;42(6):972-86. doi: 10.1007/s00134-016-4344-1. Epub 2016 Apr 15.
  PMID: 27084344
  citation: Amigoni A, Mozzo E, Brugnaro L, Gentilomo C, Stritoni V, Michelin E, Pettenazzo A. Assessing sedation in a pediatric intensive care unit using Comfort Behavioural Scale and Bispectral Index: these tools are different. Minerva Anestesiol. 2012 Mar;78(3):322-9.
  PMID: 22127309
  citation: Twite MD, Zuk J, Gralla J, Friesen RH. Correlation of the Bispectral Index Monitor with the COMFORT scale in the pediatric intensive care unit. Pediatr Crit Care Med. 2005 Nov;6(6):648-53; quiz 654.
  PMID: 16276329
  citation: Tobias JD, Grindstaff R. Bispectral index monitoring during the administration of neuromuscular blocking agents in the pediatric intensive care unit patient. J Intensive Care Med. 2005 Jul-Aug;20(4):233-7. doi: 10.1177/0885066605276806.
  PMID: 16061906
  citation: Christenson C, Martinez-Vazquez P, Breidenstein M, Farhang B, Mathews J, Melia U, Jensen EW, Mathews D. Comparison of the Conox (qCON) and Sedline (PSI) depth of anaesthesia indices to predict the hypnotic effect during desflurane general anaesthesia with ketamine. J Clin Monit Comput. 2021 Dec;35(6):1421-1428. doi: 10.1007/s10877-020-00619-3. Epub 2020 Nov 19.
  PMID: 33211251
  citation: Ista E, van Dijk M, Tibboel D, de Hoog M. Assessment of sedation levels in pediatric intensive care patients can be improved by using the COMFORT "behavior" scale. Pediatr Crit Care Med. 2005 Jan;6(1):58-63. doi: 10.1097/01.PCC.0000149318.40279.1A.
  PMID: 15636661
  citation: Smith HAB, Besunder JB, Betters KA, Johnson PN, Srinivasan V, Stormorken A, Farrington E, Golianu B, Godshall AJ, Acinelli L, Almgren C, Bailey CH, Boyd JM, Cisco MJ, Damian M, deAlmeida ML, Fehr J, Fenton KE, Gilliland F, Grant MJC, Howell J, Ruggles CA, Simone S, Su F, Sullivan JE, Tegtmeyer K, Traube C, Williams S, Berkenbosch JW. 2022 Society of Critical Care Medicine Clinical Practice Guidelines on Prevention and Management of Pain, Agitation, Neuromuscular Blockade, and Delirium in Critically Ill Pediatric Patients With Consideration of the ICU Environment and Early Mobility. Pediatr Crit Care Med. 2022 Feb 1;23(2):e74-e110. doi: 10.1097/PCC.0000000000002873.
  PMID: 35119438
  responsible party type: Principal Investigator
  investigator affiliation: Azienda Ospedaliera di Padova
  investigator full name: angela amigoni
  investigator title: Director
  sharing ipd: Undecided