<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/NCT03263988</url>
  </required_header>
  <id_info>
    <org_study_id>HD Sense</org_study_id>
    <nct_id>NCT03263988</nct_id>
  </id_info>
  <brief_title>HD Sense Pilot Study - A Novel Method of Hemodynamic Monitoring</brief_title>
  <official_title>A Novel Method of Hemodynamic Monitoring by Piezocapacitative Interlayer Sensor Technology - A Pilot Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Charite University, Berlin, Germany</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Charite University, Berlin, Germany</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>
      Measurement of arterial blood pressure is a basic monitoring in the perioperative setting. It&#xD;
      is a standard monitoring to assure an adequate cerebral perfusion pressure and is a basic&#xD;
      parameter of hemodynamic optimization. Until now standard methods for blood pressure&#xD;
      measurement are non-invasive interval monitoring by arm cuff (Riva-Rocci) or direct,&#xD;
      continuous and invasive by inserting an intraarterial catheter. This observational study will&#xD;
      show, that a new non-invasive piezocapacitative-interlayer technology will make continuous&#xD;
      blood pressure monitoring and non-invasive pulse contour analysis available.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Measurement of arterial blood pressure is a basic monitoring in the perioperative setting. It&#xD;
      is a standard monitoring to assure an adequate cerebral perfusion pressure and is a basic&#xD;
      parameter of hemodynamic optimization. Until now standard methods for blood pressure&#xD;
      measurement are non-invasive interval monitoring by arm cuff (Riva-Rocci) or direct,&#xD;
      continuous and invasive by inserting an intraarterial catheter. This observational study will&#xD;
      show, that a new non-invasive piezocapacitative-interlayer technology will make continuous&#xD;
      blood pressure monitoring and non-invasive pulse contour analysis available. For this reason&#xD;
      all patients will get a basic monitoring (NIBP, ECG, SpO2)&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date type="Actual">October 19, 2017</start_date>
  <completion_date type="Anticipated">December 31, 2019</completion_date>
  <primary_completion_date type="Actual">October 23, 2018</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>PPV</measure>
    <time_frame>Duration of surgery and perioperative care (an average of 24 hours)</time_frame>
    <description>Percentual error of PPV &lt; 30% for ConCardiac between ConCardiac and PICCO</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Duration of surgery</measure>
    <time_frame>Duration of surgery (an average of 4 hours)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Duration of anesthesia</measure>
    <time_frame>Duration of surgery (an average of 4 hours)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>intraoperative blood loss</measure>
    <time_frame>Duration of surgery and perioperative care (an average of 24 hours)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Duration of mechanical ventilation</measure>
    <time_frame>Duration of surgery (an average of 4 hours)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Duration of renal replacement therapy</measure>
    <time_frame>perioperative (an average of 10 days)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Length of hospital stay</measure>
    <time_frame>perioperative (an average of 10 days)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Blood products and volume needed perioperative</measure>
    <time_frame>perioperative (an average of 10 days)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>ICU scores (TISS)</measure>
    <time_frame>perioperative (an average of 10 days)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>ICU scores (SOFA)</measure>
    <time_frame>perioperative (an average of 10 days)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>ICU scores (SAPS)</measure>
    <time_frame>perioperative (an average of 10 days)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of organ failure or complications</measure>
    <time_frame>perioperative (an average of 10 days)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Vital signs of patients/blood pressure</measure>
    <time_frame>perioperative (an average of 10 days)</time_frame>
    <description>RR</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Vital signs of patients/heart frequency</measure>
    <time_frame>perioperative (an average of 10 days)</time_frame>
    <description>HF</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Vital signs of patients/Cardiac index</measure>
    <time_frame>perioperative (an average of 10 days)</time_frame>
    <description>CI</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Vital signs of patients/stroke volume</measure>
    <time_frame>perioperative (an average of 10 days)</time_frame>
    <description>SV</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Vital signs of patients/pulse pressure variation</measure>
    <time_frame>perioperative (an average of 10 days)</time_frame>
    <description>PPV</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Vital signs of patients/systemic vascular resistance index</measure>
    <time_frame>perioperative (an average of 10 days)</time_frame>
    <description>SVRI</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Vital signs of patients/intrathoracic blood volume index</measure>
    <time_frame>perioperative (an average of 10 days)</time_frame>
    <description>ITBV/I</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Vital signs of patients/extra vascular lung water index</measure>
    <time_frame>perioperative (an average of 10 days)</time_frame>
    <description>ELWI</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Vital signs of patients/global enddiastolic volume index</measure>
    <time_frame>perioperative (an average of 10 days)</time_frame>
    <description>GEDI</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Vital signs of patients/Ventilator settings</measure>
    <time_frame>perioperative (an average of 10 days)</time_frame>
    <description>Ventilator settings</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Vital signs of patients/blood gases</measure>
    <time_frame>perioperative (an average of 10 days)</time_frame>
    <description>BGA</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Vital signs of patients/creatinine</measure>
    <time_frame>perioperative (an average of 10 days)</time_frame>
    <description>Creatinine</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Vital signs of patients/central venous oxygen saturation</measure>
    <time_frame>perioperative (an average of 10 days)</time_frame>
    <description>ScvO2</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Vital signs of patients/central venous pressure</measure>
    <time_frame>perioperative (an average of 10 days)</time_frame>
    <description>CVP</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Vital signs of patients/diuresis</measure>
    <time_frame>perioperative (an average of 10 days)</time_frame>
    <description>Diuresis</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">39</enrollment>
  <condition>Hemodynamic Instability</condition>
  <arm_group>
    <arm_group_label>PIEZO-Group</arm_group_label>
    <description>All patients in this study receive IBP by PICCO and piezocapacitative-interlayer-technology measurement.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>ConCardiac</intervention_name>
    <description>All patients receive a piezocapacitative-interlayer-technology hemodynamic measurement by ConCardiac device (SectorCon GmbH, Berlin, Germany).</description>
    <arm_group_label>PIEZO-Group</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        18 years or older voluntary patients undergoing elective surgery at Charité -&#xD;
        Universitätsmedizin Berlin Campus Charite Mitte&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  elective surgery and general anesthesia&#xD;
&#xD;
          -  age &gt;/= 18 years&#xD;
&#xD;
          -  any surgery in ENT/trauma/gynecology/visceral surgery/thoracic surgery/urology/neuro&#xD;
             surgery/cardio surgery (N=10)&#xD;
&#xD;
          -  cardio surgery (N=10)&#xD;
&#xD;
          -  Transcatheter Aortic Valve Implantation (N=20)&#xD;
&#xD;
          -  cystectomy (N=10)&#xD;
&#xD;
          -  neurosurgery with an expected postoperative ICU stay &gt;/= 20 hours (N=10)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  pregnant or breastfeeding patients&#xD;
&#xD;
          -  emergency surgery&#xD;
&#xD;
          -  participation in a clinical interventional study&#xD;
&#xD;
          -  BMI &gt;35 kg/m²&#xD;
&#xD;
          -  impossibility to place the ConCardiac interlayer&#xD;
&#xD;
          -  difference of blood pressure of right and left arm &gt; 12 mmHg&#xD;
&#xD;
          -  pAVK Fontaine IV&#xD;
&#xD;
          -  arrythmia absoluta&#xD;
&#xD;
          -  vitium cordis &gt;/=3&#xD;
&#xD;
          -  ejection fraction &lt;35%&#xD;
&#xD;
          -  TAPSE &lt;/=16mm&#xD;
&#xD;
          -  need of IABP&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>99 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Sascha Treskatsch, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Charite University, Berlin, Germany</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Charité - Universitätsmedizin Berlin Campus Charité Mitte</name>
      <address>
        <city>Berlin</city>
        <zip>10115</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <reference>
    <citation>Giglio MT, Marucci M, Testini M, Brienza N. Goal-directed haemodynamic therapy and gastrointestinal complications in major surgery: a meta-analysis of randomized controlled trials. Br J Anaesth. 2009 Nov;103(5):637-46. doi: 10.1093/bja/aep279.</citation>
    <PMID>19837807</PMID>
  </reference>
  <reference>
    <citation>Scheer B, Perel A, Pfeiffer UJ. Clinical review: complications and risk factors of peripheral arterial catheters used for haemodynamic monitoring in anaesthesia and intensive care medicine. Crit Care. 2002 Jun;6(3):199-204. doi: 10.1186/cc1489. Epub 2002 Apr 18.</citation>
    <PMID>12133178</PMID>
  </reference>
  <reference>
    <citation>Scheeren TW, Wiesenack C, Gerlach H, Marx G. Goal-directed intraoperative fluid therapy guided by stroke volume and its variation in high-risk surgical patients: a prospective randomized multicentre study. J Clin Monit Comput. 2013 Jun;27(3):225-33. doi: 10.1007/s10877-013-9461-6. Epub 2013 Apr 5.</citation>
    <PMID>23558909</PMID>
  </reference>
  <reference>
    <citation>Auler JO Jr, Galas F, Hajjar L, Santos L, Carvalho T, Michard F. Online monitoring of pulse pressure variation to guide fluid therapy after cardiac surgery. Anesth Analg. 2008 Apr;106(4):1201-6, table of contents. doi: 10.1213/01.ane.0000287664.03547.c6.</citation>
    <PMID>18349193</PMID>
  </reference>
  <reference>
    <citation>Dalfino L, Giglio MT, Puntillo F, Marucci M, Brienza N. Haemodynamic goal-directed therapy and postoperative infections: earlier is better. A systematic review and meta-analysis. Crit Care. 2011 Jun 24;15(3):R154. doi: 10.1186/cc10284.</citation>
    <PMID>21702945</PMID>
  </reference>
  <reference>
    <citation>Sun Y, Lacour SP, Brooks RA, Rushton N, Fawcett J, Cameron RE. Assessment of the biocompatibility of photosensitive polyimide for implantable medical device use. J Biomed Mater Res A. 2009 Sep 1;90(3):648-55. doi: 10.1002/jbm.a.32125.</citation>
    <PMID>18563817</PMID>
  </reference>
  <verification_date>July 2019</verification_date>
  <study_first_submitted>August 21, 2017</study_first_submitted>
  <study_first_submitted_qc>August 24, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 28, 2017</study_first_posted>
  <last_update_submitted>July 23, 2019</last_update_submitted>
  <last_update_submitted_qc>July 23, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">July 24, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Charite University, Berlin, Germany</investigator_affiliation>
    <investigator_full_name>Sascha Treskatsch</investigator_full_name>
    <investigator_title>Prof. Dr. med./ Deputy head of department</investigator_title>
  </responsible_party>
  <keyword>pulse contour analysis</keyword>
  <keyword>capton</keyword>
  <keyword>intraoperative monitoring</keyword>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </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/NCT03263988
org study id: HD Sense
nct id: NCT03263988
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Measurement of arterial blood pressure is a basic monitoring in the perioperative setting. It
      is a standard monitoring to assure an adequate cerebral perfusion pressure and is a basic
      parameter of hemodynamic optimization. Until now standard methods for blood pressure
      measurement are non-invasive interval monitoring by arm cuff (Riva-Rocci) or direct,
      continuous and invasive by inserting an intraarterial catheter. This observational study will
      show, that a new non-invasive piezocapacitative-interlayer technology will make continuous
      blood pressure monitoring and non-invasive pulse contour analysis available.
Measurement of arterial blood pressure is a basic monitoring in the perioperative setting. It
      is a standard monitoring to assure an adequate cerebral perfusion pressure and is a basic
      parameter of hemodynamic optimization. Until now standard methods for blood pressure
      measurement are non-invasive interval monitoring by arm cuff (Riva-Rocci) or direct,
      continuous and invasive by inserting an intraarterial catheter. This observational study will
      show, that a new non-invasive piezocapacitative-interlayer technology will make continuous
      blood pressure monitoring and non-invasive pulse contour analysis available. For this reason
      all patients will get a basic monitoring (NIBP, ECG, SpO2)
observational model: Cohort
time perspective: Prospective
measure: PPV
time frame: Duration of surgery and perioperative care (an average of 24 hours)
description: Percentual error of PPV < 30% for ConCardiac between ConCardiac and PICCO
measure: Duration of surgery
time frame: Duration of surgery (an average of 4 hours)
measure: Duration of anesthesia
time frame: Duration of surgery (an average of 4 hours)
measure: intraoperative blood loss
time frame: Duration of surgery and perioperative care (an average of 24 hours)
measure: Duration of mechanical ventilation
time frame: Duration of surgery (an average of 4 hours)
measure: Duration of renal replacement therapy
time frame: perioperative (an average of 10 days)
measure: Length of hospital stay
time frame: perioperative (an average of 10 days)
measure: Blood products and volume needed perioperative
time frame: perioperative (an average of 10 days)
measure: ICU scores (TISS)
time frame: perioperative (an average of 10 days)
measure: ICU scores (SOFA)
time frame: perioperative (an average of 10 days)
measure: ICU scores (SAPS)
time frame: perioperative (an average of 10 days)
measure: Incidence of organ failure or complications
time frame: perioperative (an average of 10 days)
measure: Vital signs of patients/blood pressure
time frame: perioperative (an average of 10 days)
description: RR
measure: Vital signs of patients/heart frequency
time frame: perioperative (an average of 10 days)
description: HF
measure: Vital signs of patients/Cardiac index
time frame: perioperative (an average of 10 days)
description: CI
measure: Vital signs of patients/stroke volume
time frame: perioperative (an average of 10 days)
description: SV
measure: Vital signs of patients/pulse pressure variation
time frame: perioperative (an average of 10 days)
description: PPV
measure: Vital signs of patients/systemic vascular resistance index
time frame: perioperative (an average of 10 days)
description: SVRI
measure: Vital signs of patients/intrathoracic blood volume index
time frame: perioperative (an average of 10 days)
description: ITBV/I
measure: Vital signs of patients/extra vascular lung water index
time frame: perioperative (an average of 10 days)
description: ELWI
measure: Vital signs of patients/global enddiastolic volume index
time frame: perioperative (an average of 10 days)
description: GEDI
measure: Vital signs of patients/Ventilator settings
time frame: perioperative (an average of 10 days)
description: Ventilator settings
measure: Vital signs of patients/blood gases
time frame: perioperative (an average of 10 days)
description: BGA
measure: Vital signs of patients/creatinine
time frame: perioperative (an average of 10 days)
description: Creatinine
measure: Vital signs of patients/central venous oxygen saturation
time frame: perioperative (an average of 10 days)
description: ScvO2
measure: Vital signs of patients/central venous pressure
time frame: perioperative (an average of 10 days)
description: CVP
measure: Vital signs of patients/diuresis
time frame: perioperative (an average of 10 days)
description: Diuresis
arm group label: PIEZO-Group
description: All patients in this study receive IBP by PICCO and piezocapacitative-interlayer-technology measurement.
intervention type: Device
intervention name: ConCardiac
description: All patients receive a piezocapacitative-interlayer-technology hemodynamic measurement by ConCardiac device (SectorCon GmbH, Berlin, Germany).
arm group label: PIEZO-Group
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 99 Years
healthy volunteers: No
last name: Sascha Treskatsch, MD
role: Principal Investigator
affiliation: Charite University, Berlin, Germany
facility: 
country: Germany
citation: Giglio MT, Marucci M, Testini M, Brienza N. Goal-directed haemodynamic therapy and gastrointestinal complications in major surgery: a meta-analysis of randomized controlled trials. Br J Anaesth. 2009 Nov;103(5):637-46. doi: 10.1093/bja/aep279.
PMID: 19837807
citation: Scheer B, Perel A, Pfeiffer UJ. Clinical review: complications and risk factors of peripheral arterial catheters used for haemodynamic monitoring in anaesthesia and intensive care medicine. Crit Care. 2002 Jun;6(3):199-204. doi: 10.1186/cc1489. Epub 2002 Apr 18.
PMID: 12133178
citation: Scheeren TW, Wiesenack C, Gerlach H, Marx G. Goal-directed intraoperative fluid therapy guided by stroke volume and its variation in high-risk surgical patients: a prospective randomized multicentre study. J Clin Monit Comput. 2013 Jun;27(3):225-33. doi: 10.1007/s10877-013-9461-6. Epub 2013 Apr 5.
PMID: 23558909
citation: Auler JO Jr, Galas F, Hajjar L, Santos L, Carvalho T, Michard F. Online monitoring of pulse pressure variation to guide fluid therapy after cardiac surgery. Anesth Analg. 2008 Apr;106(4):1201-6, table of contents. doi: 10.1213/01.ane.0000287664.03547.c6.
PMID: 18349193
citation: Dalfino L, Giglio MT, Puntillo F, Marucci M, Brienza N. Haemodynamic goal-directed therapy and postoperative infections: earlier is better. A systematic review and meta-analysis. Crit Care. 2011 Jun 24;15(3):R154. doi: 10.1186/cc10284.
PMID: 21702945
citation: Sun Y, Lacour SP, Brooks RA, Rushton N, Fawcett J, Cameron RE. Assessment of the biocompatibility of photosensitive polyimide for implantable medical device use. J Biomed Mater Res A. 2009 Sep 1;90(3):648-55. doi: 10.1002/jbm.a.32125.
PMID: 18563817
responsible party type: Principal Investigator
investigator affiliation: Charite University, Berlin, Germany
investigator full name: Sascha Treskatsch
investigator title: Prof. Dr. med./ Deputy head of department
sharing ipd: No