<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/NCT03307889</url>
  </required_header>
  <id_info>
    <org_study_id>EPN dnr 2017/068</org_study_id>
    <nct_id>NCT03307889</nct_id>
  </id_info>
  <brief_title>SOMNOmedics Clinical Validation Trial</brief_title>
  <official_title>SOMNOmedics Clinical Validation Trial of Pulse Transit Time (PTT) Compared With Arterial Line in Patients Undergoing Nonvascular Surgery.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Uppsala University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Uppsala University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Observational study in which pulse transit time (PTT) as a method and the device to register&#xD;
      this data is compared with arterial blood pressure.&#xD;
&#xD;
      The population is composed of pediatric and adult patients in anesthesia or intensive care in&#xD;
      need of arterial blood pressure monitoring.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Plan to enroll patients who accept the terms of the study consecutively. The population is&#xD;
      composed by pediatric and adult patients in anesthesia and intensive care in need of close&#xD;
      blood pressure monitoring.&#xD;
&#xD;
      After informed consent from the patients themselves, patient and parents and sometimes only&#xD;
      parents.&#xD;
&#xD;
      The device measuring PTT is the prepared and calibrated with existing arterial blood&#xD;
      pressure. Data is then recorded via the storage capacity of the device and via videocamera.&#xD;
      The videocamera is used to identify large disturbances in data registration. This is to&#xD;
      identify confounding data and in the end calibrate the device to be more accurate.&#xD;
&#xD;
      Data from the PTT device and the camera is then downloaded to the study computer and to an&#xD;
      external hard drive in order to create redundancy in data storage.&#xD;
&#xD;
      Data is then analysed to compare the difference between data recorded from the PTT device and&#xD;
      arterial pressure respectively. Aim is to be able to collect sufficient data to be able to&#xD;
      decide wether to recommend or advice against clinical use.&#xD;
&#xD;
      Patient data is registered and then handled by our departmental clerk. Data is stored for ten&#xD;
      years.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 20, 2017</start_date>
  <completion_date type="Actual">January 1, 2021</completion_date>
  <primary_completion_date type="Actual">January 1, 2021</primary_completion_date>
  <study_type>Observational</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>
  <primary_outcome>
    <measure>Accuracy of pulse transit time (PTT) estimation of blood pressure against intra arterial measurement.</measure>
    <time_frame>45 minutes- 120 minutes</time_frame>
    <description>Difference in mmHg between blood pressure calculated by PTT and arterial blood pressure. A video will record the measurement session in order to determine any action correlating to changes in blood pressure. A second use of the video is to determine what other action taken around the patient causing noise or confounding measurements,</description>
  </primary_outcome>
  <enrollment type="Actual">20</enrollment>
  <condition>Blood Pressure</condition>
  <condition>Perioperative/Postoperative Complications</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Pediatric and adult patients in anesthesia or intensive care.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Arterial line planned or existing&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  suspected major perioperative hemodynamic variation.&#xD;
&#xD;
          -  non existing consent.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
  </eligibility>
  <overall_official>
    <last_name>Michael Hultström, Ass Prof</last_name>
    <role>Principal Investigator</role>
    <affiliation>Uppsala University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Akademiska Sjukhuset</name>
      <address>
        <city>Uppsala</city>
        <state>Upp</state>
        <zip>75385</zip>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Sweden</country>
  </location_countries>
  <verification_date>October 2021</verification_date>
  <study_first_submitted>October 6, 2017</study_first_submitted>
  <study_first_submitted_qc>October 6, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">October 12, 2017</study_first_posted>
  <last_update_submitted>October 16, 2021</last_update_submitted>
  <last_update_submitted_qc>October 16, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">October 19, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Uppsala University</investigator_affiliation>
    <investigator_full_name>Michael Hultström</investigator_full_name>
    <investigator_title>Associate professor</investigator_title>
  </responsible_party>
  <keyword>perioperative monitoring</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Postoperative Complications</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>Anonymous data will be made available to interested researchers after publication. The patients are informed of this fact.</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
    <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
    <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
    <ipd_info_type>Analytic Code</ipd_info_type>
    <ipd_time_frame>Supporting information will be made available after publication.</ipd_time_frame>
    <ipd_access_criteria>Data and supporting information will be made available to interested researchers upon request.</ipd_access_criteria>
  </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/NCT03307889
org study id: EPN dnr 2017/068
nct id: NCT03307889
lead sponsor: 
has dmc: No
Observational study in which pulse transit time (PTT) as a method and the device to register
      this data is compared with arterial blood pressure.

      The population is composed of pediatric and adult patients in anesthesia or intensive care in
      need of arterial blood pressure monitoring.
Plan to enroll patients who accept the terms of the study consecutively. The population is
      composed by pediatric and adult patients in anesthesia and intensive care in need of close
      blood pressure monitoring.

      After informed consent from the patients themselves, patient and parents and sometimes only
      parents.

      The device measuring PTT is the prepared and calibrated with existing arterial blood
      pressure. Data is then recorded via the storage capacity of the device and via videocamera.
      The videocamera is used to identify large disturbances in data registration. This is to
      identify confounding data and in the end calibrate the device to be more accurate.

      Data from the PTT device and the camera is then downloaded to the study computer and to an
      external hard drive in order to create redundancy in data storage.

      Data is then analysed to compare the difference between data recorded from the PTT device and
      arterial pressure respectively. Aim is to be able to collect sufficient data to be able to
      decide wether to recommend or advice against clinical use.

      Patient data is registered and then handled by our departmental clerk. Data is stored for ten
      years.
observational model: Case-Only
time perspective: Prospective
measure: Accuracy of pulse transit time (PTT) estimation of blood pressure against intra arterial measurement.
time frame: 45 minutes- 120 minutes
description: Difference in mmHg between blood pressure calculated by PTT and arterial blood pressure. A video will record the measurement session in order to determine any action correlating to changes in blood pressure. A second use of the video is to determine what other action taken around the patient causing noise or confounding measurements,
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
last name: Michael Hultström, Ass Prof
role: Principal Investigator
affiliation: Uppsala University
facility: 
country: Sweden
responsible party type: Principal Investigator
investigator affiliation: Uppsala University
investigator full name: Michael Hultström
investigator title: Associate professor
mesh term: Postoperative Complications
sharing ipd: Yes
ipd description: Anonymous data will be made available to interested researchers after publication. The patients are informed of this fact.
ipd info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)
ipd info type: Informed Consent Form (ICF)
ipd info type: Clinical Study Report (CSR)
ipd info type: Analytic Code
ipd time frame: Supporting information will be made available after publication.
ipd access criteria: Data and supporting information will be made available to interested researchers upon request.