<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/NCT03027817</url>
  </required_header>
  <id_info>
    <org_study_id>NIMHANS</org_study_id>
    <nct_id>NCT03027817</nct_id>
  </id_info>
  <brief_title>Cardiac Output and Other Hemodynamic Changes With Prone Position in Cervical Myelopathy Patients Undergoing Surgery</brief_title>
  <official_title>Cardiac Output and Other Hemodynamic Changes With Prone Position in Cervical Myelopathy Patients Undergoing Surgery</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Dhritiman Chakrabarti</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>National Institute of Mental Health and Neuro Sciences, India</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Positioning a patient in prone position under anaesthesia significantly alters cardiovascular&#xD;
      physiology. Cervical myelopathy patients are known to have autonomic dysfunction. Such&#xD;
      patients when positioned in prone position under anaesthesia carry a higher risk of&#xD;
      developing hemodynamic changes and this can compromise spinal cord perfusion.&#xD;
&#xD;
      This prospective observational study was conducted on 30 patients with cervical myelopathy&#xD;
      who underwent surgery in prone position at NIMHANS, Bangalore hospital. The non invasive&#xD;
      cardiac output monitor (NICOM, Cheetah Medicals) was used to record various hemodynamic&#xD;
      parameters. The hemodynamic parameters were recorded at baseline, post induction, post&#xD;
      intubation, prior to prone position, post prone position, and every five minutes thereafter&#xD;
      upto 20mins.&#xD;
&#xD;
      The hemodynamic parameters that were recorded using the NICOM monitor:&#xD;
&#xD;
        -  HR - Heart rate (beats /min)&#xD;
&#xD;
        -  NIBP - non invasive blood pressure (mmHg)&#xD;
&#xD;
        -  MAP - mean arterial pressure(mmHg)&#xD;
&#xD;
        -  CO - cardiac output (l/min)&#xD;
&#xD;
        -  CI - cardiac index (l/min/m2)&#xD;
&#xD;
        -  SV - Stroke volume (ml/beat)&#xD;
&#xD;
        -  SVV -stroke volume variability (%)&#xD;
&#xD;
        -  TPR - total peripheral resistance (dynes. sec/cm5)&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>November 2014</start_date>
  <completion_date type="Actual">December 2015</completion_date>
  <primary_completion_date type="Actual">December 2015</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>Mean arterial pressure</measure>
    <time_frame>Before induction of anaesthesia to 20 minutes after prone positioning (end of study)</time_frame>
    <description>Analysis of change in mean arterial pressure at following time points - before induction of anaesthesia, 2 minutes after anaesthetic induction, 2 minutes after intubation, before turning prone, immediately after turning prone and every 5 minutes thereafter till 20 minutes after positioning.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Heart rate</measure>
    <time_frame>Before induction of anaesthesia to 20 minutes after prone positioning (end of study)</time_frame>
    <description>Analysis of change in heart rate at following time points - before induction of anaesthesia, 2 minutes after anaesthetic induction, 2 minutes after intubation, before turning prone, immediately after turning prone and every 5 minutes thereafter till 20 minutes after positioning.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cardiac output</measure>
    <time_frame>Before induction of anaesthesia to 20 minutes after prone positioning (end of study)</time_frame>
    <description>Analysis of change in cardiac output at following time points - before induction of anaesthesia, 2 minutes after anaesthetic induction, 2 minutes after intubation, before turning prone, immediately after turning prone and every 5 minutes thereafter till 20 minutes after positioning.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Stroke volume</measure>
    <time_frame>Before induction of anaesthesia to 20 minutes after prone positioning (end of study)</time_frame>
    <description>Analysis of change in stroke volume at following time points - before induction of anaesthesia, 2 minutes after anaesthetic induction, 2 minutes after intubation, before turning prone, immediately after turning prone and every 5 minutes thereafter till 20 minutes after positioning.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Stroke volume variation</measure>
    <time_frame>Before induction of anaesthesia to 20 minutes after prone positioning (end of study)</time_frame>
    <description>Analysis of change in stroke volume variation at following time points - before induction of anaesthesia, 2 minutes after anaesthetic induction, 2 minutes after intubation, before turning prone, immediately after turning prone and every 5 minutes thereafter till 20 minutes after positioning.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Total peripheral resistance</measure>
    <time_frame>Before induction of anaesthesia to 20 minutes after prone positioning (end of study)</time_frame>
    <description>Analysis of change in total peripheral resistance at following time points - before induction of anaesthesia, 2 minutes after anaesthetic induction, 2 minutes after intubation, before turning prone, immediately after turning prone and every 5 minutes thereafter till 20 minutes after positioning.</description>
  </secondary_outcome>
  <enrollment type="Actual">30</enrollment>
  <condition>Hemodynamics Instability</condition>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Prone Positioning</intervention_name>
    <description>Noninvasive cardiac output monitoring parameters were recorded before and after prone positioning.</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients with Cervical Myelopathy undergoing elective cervical decompression in prone&#xD;
        position.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Cervical myelopathy patients undergoing surgery in prone position with:&#xD;
&#xD;
          -  ASA Class I , II and III&#xD;
&#xD;
          -  Age between 18 to 65 years&#xD;
&#xD;
          -  Nurick's grade 2 or more&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Atlanto occipital dislocation and cervicomedullary junction pathology&#xD;
&#xD;
          -  Tumour pathology&#xD;
&#xD;
          -  Diabetic patients&#xD;
&#xD;
          -  Patients positioned prone in the awake state (without induction of anaesthesia)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Nitin Manohar, MD, DNB, DM</last_name>
    <role>Principal Investigator</role>
    <affiliation>National Institute of Mental Health and Neuro Sciences, Bangalore</affiliation>
  </overall_official>
  <verification_date>January 2017</verification_date>
  <study_first_submitted>January 18, 2017</study_first_submitted>
  <study_first_submitted_qc>January 20, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 23, 2017</study_first_posted>
  <last_update_submitted>January 20, 2017</last_update_submitted>
  <last_update_submitted_qc>January 20, 2017</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 23, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>National Institute of Mental Health and Neuro Sciences, India</investigator_affiliation>
    <investigator_full_name>Dhritiman Chakrabarti</investigator_full_name>
    <investigator_title>Assistant Professor of Neuroanaesthesiology</investigator_title>
  </responsible_party>
  <keyword>Prone positioning</keyword>
  <keyword>Non-invasive Cardiac Output Monitoring</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Spinal Cord Diseases</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>There is no plan to share IPD with other researchers. If required, the Sponsor-Investigator may be contacted via email shared on this portal.</ipd_description>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


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/NCT03027817
org study id: NIMHANS
nct id: NCT03027817
lead sponsor: 
has dmc: No
Positioning a patient in prone position under anaesthesia significantly alters cardiovascular
      physiology. Cervical myelopathy patients are known to have autonomic dysfunction. Such
      patients when positioned in prone position under anaesthesia carry a higher risk of
      developing hemodynamic changes and this can compromise spinal cord perfusion.

      This prospective observational study was conducted on 30 patients with cervical myelopathy
      who underwent surgery in prone position at NIMHANS, Bangalore hospital. The non invasive
      cardiac output monitor (NICOM, Cheetah Medicals) was used to record various hemodynamic
      parameters. The hemodynamic parameters were recorded at baseline, post induction, post
      intubation, prior to prone position, post prone position, and every five minutes thereafter
      upto 20mins.

      The hemodynamic parameters that were recorded using the NICOM monitor:

        -  HR - Heart rate (beats /min)

        -  NIBP - non invasive blood pressure (mmHg)

        -  MAP - mean arterial pressure(mmHg)

        -  CO - cardiac output (l/min)

        -  CI - cardiac index (l/min/m2)

        -  SV - Stroke volume (ml/beat)

        -  SVV -stroke volume variability (%)

        -  TPR - total peripheral resistance (dynes. sec/cm5)
observational model: Cohort
time perspective: Prospective
measure: Mean arterial pressure
time frame: Before induction of anaesthesia to 20 minutes after prone positioning (end of study)
description: Analysis of change in mean arterial pressure at following time points - before induction of anaesthesia, 2 minutes after anaesthetic induction, 2 minutes after intubation, before turning prone, immediately after turning prone and every 5 minutes thereafter till 20 minutes after positioning.
measure: Heart rate
time frame: Before induction of anaesthesia to 20 minutes after prone positioning (end of study)
description: Analysis of change in heart rate at following time points - before induction of anaesthesia, 2 minutes after anaesthetic induction, 2 minutes after intubation, before turning prone, immediately after turning prone and every 5 minutes thereafter till 20 minutes after positioning.
measure: Cardiac output
time frame: Before induction of anaesthesia to 20 minutes after prone positioning (end of study)
description: Analysis of change in cardiac output at following time points - before induction of anaesthesia, 2 minutes after anaesthetic induction, 2 minutes after intubation, before turning prone, immediately after turning prone and every 5 minutes thereafter till 20 minutes after positioning.
measure: Stroke volume
time frame: Before induction of anaesthesia to 20 minutes after prone positioning (end of study)
description: Analysis of change in stroke volume at following time points - before induction of anaesthesia, 2 minutes after anaesthetic induction, 2 minutes after intubation, before turning prone, immediately after turning prone and every 5 minutes thereafter till 20 minutes after positioning.
measure: Stroke volume variation
time frame: Before induction of anaesthesia to 20 minutes after prone positioning (end of study)
description: Analysis of change in stroke volume variation at following time points - before induction of anaesthesia, 2 minutes after anaesthetic induction, 2 minutes after intubation, before turning prone, immediately after turning prone and every 5 minutes thereafter till 20 minutes after positioning.
measure: Total peripheral resistance
time frame: Before induction of anaesthesia to 20 minutes after prone positioning (end of study)
description: Analysis of change in total peripheral resistance at following time points - before induction of anaesthesia, 2 minutes after anaesthetic induction, 2 minutes after intubation, before turning prone, immediately after turning prone and every 5 minutes thereafter till 20 minutes after positioning.
intervention type: Procedure
intervention name: Prone Positioning
description: Noninvasive cardiac output monitoring parameters were recorded before and after prone positioning.
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: Nitin Manohar, MD, DNB, DM
role: Principal Investigator
affiliation: National Institute of Mental Health and Neuro Sciences, Bangalore
responsible party type: Sponsor-Investigator
investigator affiliation: National Institute of Mental Health and Neuro Sciences, India
investigator full name: Dhritiman Chakrabarti
investigator title: Assistant Professor of Neuroanaesthesiology
mesh term: Spinal Cord Diseases
sharing ipd: No
ipd description: There is no plan to share IPD with other researchers. If required, the Sponsor-Investigator may be contacted via email shared on this portal.