<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/NCT03250065</url>
  </required_header>
  <id_info>
    <org_study_id>RCBE/2015/01</org_study_id>
    <nct_id>NCT03250065</nct_id>
  </id_info>
  <brief_title>The Sensing ET Tube</brief_title>
  <acronym>SETT</acronym>
  <official_title>Development of the &quot;Sensing Endotracheal Tube&quot;: an Optical Multi-parameter Monitoring System.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>City, University of London</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Barts &amp; The London NHS Trust</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>City, University of London</source>
  <oversight_info>
    <has_dmc>Yes</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>
      This proposal describes the development of a 'Sensing ET Tube'. This device will replace the&#xD;
      standard endotracheal (ET) tube used in anaesthesia and in ventilated intensive care patients&#xD;
      and provide key vital signs monitoring utilising optoelectronic sensors. Continuous&#xD;
      monitoring of patients' arterial oxygen saturation is essential during surgery, however pulse&#xD;
      oximeters often misread or fail altogether as a result of peripheral vasoconstriction,&#xD;
      hypotension or hypovolaemia. The Sensing ET Tube will allow continuous measurement of oxygen&#xD;
      saturation and other parameters, such as pulse rate, from a single internal site, and will&#xD;
      reduce the number of surface sensors placed on the skin and the number of electrical&#xD;
      connections to the patient. The applicants have already developed similar sensor technology&#xD;
      in the oesophagus and other internal locations. A pilot clinical evaluation of the device&#xD;
      will be completed in anaesthetised patients undergoing surgery. The project will lead to&#xD;
      further development of a multi-sensor tracheal platform for comprehensive anaesthesia and&#xD;
      intensive care monitoring.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The aim of this project is to develop and evaluate a novel medical device known as the&#xD;
      'Sensing ET Tube' for measuring oxygen levels in patients undergoing surgical operations. The&#xD;
      device replaces the standard breathing tube used in surgery and incorporates photonic sensors&#xD;
      for measurement of the patient's oxygen level and other vital signs. Currently this&#xD;
      information is supplied from finger probes, which can fail often, for example when the&#xD;
      patient is cold or when the blood pressure is low. The new device is completely harmless and&#xD;
      allows the anaesthetist to monitor the oxygen level from the central region of the body using&#xD;
      minimal connections. If successful, future work is planned to incorporate other sensors into&#xD;
      the system, providing a complete overview of the health of the patient. This will greatly&#xD;
      simplify the process of patient monitoring while reducing the number of failures, improving&#xD;
      patient safety and reducing operating costs.&#xD;
&#xD;
      A clinical trial is planned in up to 50 patients undergoing general anaesthesia, which will&#xD;
      quantitatively evaluate the accuracy and reliability of the measured clinical variables and&#xD;
      the device's expected performance in mainstream operation. This information will provide the&#xD;
      basis for further commercial development, most likely through partnership with a medical&#xD;
      device manufacturer.&#xD;
&#xD;
      To summarise, the main aims of the project are:&#xD;
&#xD;
        -  Investigate photoplethysmographic signals from the human trachea and identify viability&#xD;
           to measure heart rate, and blood oxygen saturation by comparison with &quot;gold standard&quot;&#xD;
           techniques.&#xD;
&#xD;
        -  Evaluate custom-designed endotracheal sensor for operation and determine ideal&#xD;
           electrical characteristics for optimal operation (current supply, detector amplification&#xD;
           etc.)&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 3, 2017</start_date>
  <completion_date type="Actual">September 30, 2017</completion_date>
  <primary_completion_date type="Actual">July 31, 2017</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>To validate the pulse oximetry signals from the trachea during anaesthesia for their suitability in determining vital signs, not limited to just oxygen saturation.</measure>
    <time_frame>1 year</time_frame>
    <description>Raw optical electrical signals related to the absorbion of red and infrared light from the prototype sensor by the tissue in the trachea will be assessed for their viability to reliable determine pulse rate and oxygen saturation compared to the standard clinical devices during surgery. The signals will be further analysed to look for correlation with recorded blood pressure measurents and respiration rates.</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">16</enrollment>
  <condition>Diagnostic Equipment</condition>
  <condition>Oximetry</condition>
  <condition>Pulse Rate</condition>
  <arm_group>
    <arm_group_label>ETT Study Group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The Sensing ET Tube study Group</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Application of prototype sensor to a standard endotracheal tube</intervention_name>
    <description>During anaesthesia the device under study, a prototype saturation sensor will be applied to a standard endotracheal tube that ventilates the patient as normal.</description>
    <arm_group_label>ETT Study Group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  ASA I-III&#xD;
&#xD;
          -  18 Years and older&#xD;
&#xD;
          -  Undergoing elective surgery requiring general anaesthesia, and endotracheal tube as&#xD;
             part of their anaesthetic.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Those who refuse consent&#xD;
&#xD;
          -  Known or potentially difficult airway&#xD;
&#xD;
          -  Respiratory conditions including severe asthma, COPD, lung cancer etc.&#xD;
&#xD;
          -  Pregnant women&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Saowarat Snidvongs, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Barts and The London NHS Trust</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Justin Phillips, PhD</last_name>
    <role>Study Director</role>
    <affiliation>City, University of London</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Panayiotis A Kyriacou, PhD</last_name>
    <role>Study Chair</role>
    <affiliation>City, University of London</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>City, University of London</name>
      <address>
        <city>London</city>
        <zip>EC1V0HB</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Barts and The London NHS Trust</name>
      <address>
        <city>London</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>February 2018</verification_date>
  <study_first_submitted>August 9, 2017</study_first_submitted>
  <study_first_submitted_qc>August 14, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 15, 2017</study_first_posted>
  <last_update_submitted>February 8, 2018</last_update_submitted>
  <last_update_submitted_qc>February 8, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">February 12, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>all data is anonymised and raw signals are only shared among the named investigators</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/NCT03250065
org study id: RCBE/2015/01
nct id: NCT03250065
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
This proposal describes the development of a 'Sensing ET Tube'. This device will replace the
      standard endotracheal (ET) tube used in anaesthesia and in ventilated intensive care patients
      and provide key vital signs monitoring utilising optoelectronic sensors. Continuous
      monitoring of patients' arterial oxygen saturation is essential during surgery, however pulse
      oximeters often misread or fail altogether as a result of peripheral vasoconstriction,
      hypotension or hypovolaemia. The Sensing ET Tube will allow continuous measurement of oxygen
      saturation and other parameters, such as pulse rate, from a single internal site, and will
      reduce the number of surface sensors placed on the skin and the number of electrical
      connections to the patient. The applicants have already developed similar sensor technology
      in the oesophagus and other internal locations. A pilot clinical evaluation of the device
      will be completed in anaesthetised patients undergoing surgery. The project will lead to
      further development of a multi-sensor tracheal platform for comprehensive anaesthesia and
      intensive care monitoring.
The aim of this project is to develop and evaluate a novel medical device known as the
      'Sensing ET Tube' for measuring oxygen levels in patients undergoing surgical operations. The
      device replaces the standard breathing tube used in surgery and incorporates photonic sensors
      for measurement of the patient's oxygen level and other vital signs. Currently this
      information is supplied from finger probes, which can fail often, for example when the
      patient is cold or when the blood pressure is low. The new device is completely harmless and
      allows the anaesthetist to monitor the oxygen level from the central region of the body using
      minimal connections. If successful, future work is planned to incorporate other sensors into
      the system, providing a complete overview of the health of the patient. This will greatly
      simplify the process of patient monitoring while reducing the number of failures, improving
      patient safety and reducing operating costs.

      A clinical trial is planned in up to 50 patients undergoing general anaesthesia, which will
      quantitatively evaluate the accuracy and reliability of the measured clinical variables and
      the device's expected performance in mainstream operation. This information will provide the
      basis for further commercial development, most likely through partnership with a medical
      device manufacturer.

      To summarise, the main aims of the project are:

        -  Investigate photoplethysmographic signals from the human trachea and identify viability
           to measure heart rate, and blood oxygen saturation by comparison with "gold standard"
           techniques.

        -  Evaluate custom-designed endotracheal sensor for operation and determine ideal
           electrical characteristics for optimal operation (current supply, detector amplification
           etc.)
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: To validate the pulse oximetry signals from the trachea during anaesthesia for their suitability in determining vital signs, not limited to just oxygen saturation.
time frame: 1 year
description: Raw optical electrical signals related to the absorbion of red and infrared light from the prototype sensor by the tissue in the trachea will be assessed for their viability to reliable determine pulse rate and oxygen saturation compared to the standard clinical devices during surgery. The signals will be further analysed to look for correlation with recorded blood pressure measurents and respiration rates.
arm group label: ETT Study Group
arm group type: Experimental
description: The Sensing ET Tube study Group
intervention type: Device
intervention name: Application of prototype sensor to a standard endotracheal tube
description: During anaesthesia the device under study, a prototype saturation sensor will be applied to a standard endotracheal tube that ventilates the patient as normal.
arm group label: ETT Study Group
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Saowarat Snidvongs, MD
role: Principal Investigator
affiliation: Barts and The London NHS Trust
last name: Justin Phillips, PhD
role: Study Director
affiliation: City, University of London
last name: Panayiotis A Kyriacou, PhD
role: Study Chair
affiliation: City, University of London
facility: 
facility: 
country: United Kingdom
responsible party type: Sponsor
sharing ipd: No
ipd description: all data is anonymised and raw signals are only shared among the named investigators