<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/NCT03279458</url>
  </required_header>
  <id_info>
    <org_study_id>2017-0063</org_study_id>
    <nct_id>NCT03279458</nct_id>
  </id_info>
  <brief_title>Non-invasive Tidal Volume Monitoring Using the Linshom Respiratory Monitoring Device</brief_title>
  <official_title>Non-invasive Tidal Volume Monitoring Using the Linshom Respiratory Monitoring Device</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Mississippi Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Mississippi Medical Center</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <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>
      Many post-operative complications arise from patients who breathe inadequately. Inadequate&#xD;
      respiration, whether the result of surgery or the anesthesia, causes a decrease in blood&#xD;
      oxygen saturation and an increase in carbon dioxide partial pressure. Both of these surrogate&#xD;
      measurements of respiration may pose a challenge to measure. Some administer exogenous oxygen&#xD;
      to all patients as they leave the operating room in order to maintain the blood oxygen&#xD;
      saturation. This renders the oximeter a less sensitive metric of depressed respiration. In&#xD;
      the face of decreased respiration, the carbon dioxide levels continue to increase slowly and&#xD;
      often go undetected unless blood gases are measured. Indeed carbon dioxide blood levels are&#xD;
      the only metric to detect inadequate ventilation using this surrogate index.&#xD;
&#xD;
      Monitoring ventilation is a serious challenge outside of critical care settings. In fact,&#xD;
      there are no monitors available that can measure tidal volume or relative tidal volume&#xD;
      outside of these settings.&#xD;
&#xD;
      Linshom is a novel instrument that tracks relative respiration by measuring the excursions of&#xD;
      the temperature swings between inspiration and expiration and normalizing them to the&#xD;
      patient's breathing. This monitor may be the first non-invasive monitor to measure relative&#xD;
      tidal volume in non-critical care settings.&#xD;
&#xD;
      The purpose of this study is to determine whether a non-invasive, temperature-based&#xD;
      respiratory instrument can track tidal volume (Vt) in patients.&#xD;
&#xD;
      The investigators hypothesize that the Linshom device can accurately and consistently track&#xD;
      tidal volume as measured by closed loop mechanical ventilator.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Forty volunteers will be enrolled in this open label, prospective study to determine the&#xD;
      correlation between the tidal volumes measured with the Linshom detector and those measured&#xD;
      with the mechanical ventilator. after Institutional Review Board (IRB) approval and written&#xD;
      informed consent from the volunteers.&#xD;
&#xD;
      The Linshom detector, which is comprised of two rapid responding medical-grade thermistors in&#xD;
      close proximity to the mouth/nose (sensor) and a thermistor remote to the airway, will be&#xD;
      mounted in the continuous positive airway pressure (CPAP) face mask to measure the&#xD;
      temperature during breathing. The CPAP will be connected to a Servo-I ventilator (Maquet)&#xD;
      with a circuit and disposable filter. The volunteers will be instructed to breathe normal&#xD;
      through the CPAP mask on room air. The excursions of the thermistor tracings (from valley to&#xD;
      peak) will be recorded by the Linshom device and displayed continuously on a laptop monitor&#xD;
      in a waveform. The tidal volume will also be measured by the ventilator and the data&#xD;
      downloaded in a Compact Flash card. The temperature profiles from the sensors and the&#xD;
      relative tidal volume will be correlated with the tidal volumes measured by the ventilator.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 8, 2017</start_date>
  <completion_date type="Actual">September 8, 2017</completion_date>
  <primary_completion_date type="Actual">September 8, 2017</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Tidal Volume of Each Breath Was Measured Using the Same Breathing Mask CPAP Apparatus Combined With Respiratory Monitoring Device Allowing for Simultaneous Recording.</measure>
    <time_frame>5 minutes</time_frame>
    <description>Tidal volume measured by CPAP mask with Lishom respiratory monitoring device. Tidal volume determined from the ventilator will be compared to tidal volume measured by Linshom (calculated indirectly by temperature changes by computer algorithm)</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">40</enrollment>
  <condition>Pulmonary Ventilation</condition>
  <condition>Capnography</condition>
  <arm_group>
    <arm_group_label>Linshom Respiratory Monitoring Device</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Volunteers will breathe through a continuous positive airway pressure (CPAP) face mask fitted with the Linshom device. The volunteers will be instructed to breathe normal through the CPAP mask on room air. The excursions of the thermistor tracings (from valley to peak) will be recorded by the Linshom device and displayed continuously on a laptop monitor in a waveform.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Ventilator</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Volunteers will breathe through a continuous positive airway pressure (CPAP) face mask fitted with the Linshom device. The volunteers will be instructed to breathe normal through the CPAP mask on room air.The tidal volume will also be measured by the ventilator and the data downloaded in a Compact Flash card.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Linshom Respiratory Monitoring Device</intervention_name>
    <description>Volunteers will breathe through a continuous positive airway pressure (CPAP) face mask fitted wth the Linshom device. The volunteers will be instructed to breathe normal through the CPAP mask on room air. The excursions of the thermistor tracings (from valley to peak) will be recorded by the Linshom device and displayed continuously on a laptop monitor in a waveform. The tidal volume will also be measured by the ventilator and the data downloaded in a Compact Flash card.</description>
    <arm_group_label>Linshom Respiratory Monitoring Device</arm_group_label>
    <arm_group_label>Ventilator</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  healthy&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  pregnant&#xD;
&#xD;
          -  suffer from claustrophobia&#xD;
&#xD;
          -  had recent respiratory illness&#xD;
&#xD;
          -  had recent gastrointestinal illness&#xD;
&#xD;
          -  unable to provide informed consent&#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>Madhankumar Sathyamoorthy, MBBS, MS</last_name>
    <role>Principal Investigator</role>
    <affiliation>Children's of Mississippi/University of Mississippi Medical Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Mississippi Medical Center</name>
      <address>
        <city>Jackson</city>
        <state>Mississippi</state>
        <zip>39216</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>http://www.asaabstracts.com/strands/asaabstracts/abstract.htm%20%20;jsessionid=682567A35143EC5A44D16DFEEE86493A?year=2015&amp;index=8&amp;absnum=4494</url>
    <description>A thermodynamic breathing sensor - a new non-invasive monitor of respiration</description>
  </link>
  <reference>
    <citation>Manifold CA, Davids N, Villers LC, Wampler DA. Capnography for the nonintubated patient in the emergency setting. J Emerg Med. 2013 Oct;45(4):626-32. doi: 10.1016/j.jemermed.2013.05.012. Epub 2013 Jul 18.</citation>
    <PMID>23871325</PMID>
  </reference>
  <reference>
    <citation>Brouillette RT, Morrow AS, Weese-Mayer DE, Hunt CE. Comparison of respiratory inductive plethysmography and thoracic impedance for apnea monitoring. J Pediatr. 1987 Sep;111(3):377-83. doi: 10.1016/s0022-3476(87)80457-2.</citation>
    <PMID>3625404</PMID>
  </reference>
  <reference>
    <citation>Ramsay MA, Usman M, Lagow E, Mendoza M, Untalan E, De Vol E. The accuracy, precision and reliability of measuring ventilatory rate and detecting ventilatory pause by rainbow acoustic monitoring and capnometry. Anesth Analg. 2013 Jul;117(1):69-75. doi: 10.1213/ANE.0b013e318290c798. Epub 2013 Apr 30.</citation>
    <PMID>23632055</PMID>
  </reference>
  <reference>
    <citation>Keidan I, Gravenstein D, Berkenstadt H, Ziv A, Shavit I, Sidi A. Supplemental oxygen compromises the use of pulse oximetry for detection of apnea and hypoventilation during sedation in simulated pediatric patients. Pediatrics. 2008 Aug;122(2):293-8. doi: 10.1542/peds.2007-2385.</citation>
    <PMID>18676546</PMID>
  </reference>
  <reference>
    <citation>Williamson JA, Webb RK, Cockings J, Morgan C. The Australian Incident Monitoring Study. The capnograph: applications and limitations--an analysis of 2000 incident reports. Anaesth Intensive Care. 1993 Oct;21(5):551-7. doi: 10.1177/0310057X9302100510.</citation>
    <PMID>8273874</PMID>
  </reference>
  <reference>
    <citation>Nassi N, Piumelli R, Lombardi E, Landini L, Donzelli G, de Martino M. Comparison between pulse oximetry and transthoracic impedance alarm traces during home monitoring. Arch Dis Child. 2008 Feb;93(2):126-32. doi: 10.1136/adc.2007.118513. Epub 2007 Sep 24.</citation>
    <PMID>17893118</PMID>
  </reference>
  <reference>
    <citation>Kasuya Y, Akca O, Sessler DI, Ozaki M, Komatsu R. Accuracy of postoperative end-tidal Pco2 measurements with mainstream and sidestream capnography in non-obese patients and in obese patients with and without obstructive sleep apnea. Anesthesiology. 2009 Sep;111(3):609-15. doi: 10.1097/ALN.0b013e3181b060b6.</citation>
    <PMID>19672177</PMID>
  </reference>
  <reference>
    <citation>Lerman J, Feldman D, Feldman R, Moser J, Feldman L, Sathyamoorthy M, Deitch K, Feldman U. Linshom respiratory monitoring device: a novel temperature-based respiratory monitor. Can J Anaesth. 2016 Oct;63(10):1154-1160. doi: 10.1007/s12630-016-0694-y. Epub 2016 Jul 13.</citation>
    <PMID>27412466</PMID>
  </reference>
  <verification_date>July 2018</verification_date>
  <study_first_submitted>September 6, 2017</study_first_submitted>
  <study_first_submitted_qc>September 8, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 12, 2017</study_first_posted>
  <results_first_submitted>October 24, 2017</results_first_submitted>
  <results_first_submitted_qc>July 3, 2018</results_first_submitted_qc>
  <results_first_posted type="Actual">July 5, 2018</results_first_posted>
  <last_update_submitted>July 3, 2018</last_update_submitted>
  <last_update_submitted_qc>July 3, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">July 5, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Mississippi Medical Center</investigator_affiliation>
    <investigator_full_name>Madhankumar Sathyamoorthy</investigator_full_name>
    <investigator_title>Associate Professor</investigator_title>
  </responsible_party>
  <keyword>Capnography</keyword>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>No plan to share IPD</ipd_description>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>June 21, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/58/NCT03279458/Prot_SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Linshom Respiratory Monitoring Device</title>
          <description>Volunteers will breathe through a continuous positive airway pressure (CPAP) face mask fitted with the Linshom device. The volunteers will be instructed to breathe normal through the CPAP mask on room air. The excursions of the thermistor tracings (from valley to peak) will be recorded by the Linshom device and displayed continuously on a laptop monitor in a waveform. The tidal volume will also be measured by the ventilator and the data downloaded in a Compact Flash card.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="40"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="40"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Linshom</title>
          <description>Linshom Respiratory Monitoring Device: Volunteers will breathe through a continuous positive airway pressure (CPAP) face mask fitted wth the Linshom device. The volunteers will be instructed to breathe normal through the CPAP mask on room air. The excursions of the thermistor tracings (from valley to peak) will be recorded by the Linshom device and displayed continuously on a laptop monitor in a waveform. The tidal volume will also be measured by the ventilator and the data downloaded in a Compact Flash card.</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="40"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age, Customized</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>&gt;= 18 years</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="40"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="40"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <population>The sex of participants was not collected.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Female</title>
                </category>
                <category>
                  <title>Male</title>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race and Ethnicity Not Collected</title>
          <population>Race and Ethnicity were not collected from any participant.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>United States</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="40"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="40"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Number of participants</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="40"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="40"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Tidal Volume of Each Breath Was Measured Using the Same Breathing Mask CPAP Apparatus Combined With Respiratory Monitoring Device Allowing for Simultaneous Recording.</title>
        <description>Tidal volume measured by CPAP mask with Lishom respiratory monitoring device. Tidal volume determined from the ventilator will be compared to tidal volume measured by Linshom (calculated indirectly by temperature changes by computer algorithm)</description>
        <time_frame>5 minutes</time_frame>
        <population>Thirty participants successfully completed the experiment, which involved breathing through a CPAP mask in order to have the Linshom device record excursions of the thermistor tracings while the ventilator concurrently measured tidal volume.</population>
        <group_list>
          <group group_id="O1">
            <title>Linshom</title>
            <description>Linshom Respiratory Monitoring Device: Volunteers will breathe through a continuous positive airway pressure (CPAP) face mask fitted wth the Linshom device. The volunteers will be instructed to breathe normal through the CPAP mask on room air. The excursions of the thermistor tracings (from valley to peak) will be recorded by the Linshom device and displayed continuously on a laptop monitor in a waveform. The tidal volume will also be measured by the ventilator and the data downloaded in a Compact Flash card.</description>
          </group>
          <group group_id="O2">
            <title>Maquet Ventilator</title>
            <description>Tidal volume measured by the Maquet ventilator connected to CPAP mask concurrently with Linshom</description>
          </group>
        </group_list>
        <measure>
          <title>Tidal Volume of Each Breath Was Measured Using the Same Breathing Mask CPAP Apparatus Combined With Respiratory Monitoring Device Allowing for Simultaneous Recording.</title>
          <description>Tidal volume measured by CPAP mask with Lishom respiratory monitoring device. Tidal volume determined from the ventilator will be compared to tidal volume measured by Linshom (calculated indirectly by temperature changes by computer algorithm)</description>
          <population>Thirty participants successfully completed the experiment, which involved breathing through a CPAP mask in order to have the Linshom device record excursions of the thermistor tracings while the ventilator concurrently measured tidal volume.</population>
          <units>ml</units>
          <param>Least Squares Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="30"/>
                <count group_id="O2" value="30"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.94" lower_limit="0.88" upper_limit="0.97"/>
                    <measurement group_id="O2" value="0.94" lower_limit="0.88" upper_limit="0.97"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>least square regression analysis</non_inferiority_desc>
            <p_value>&lt;0.05</p_value>
            <method>Regression, Linear</method>
            <param_type>correlation coefficient (R)</param_type>
            <param_value>0.94</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.88</ci_lower_limit>
            <ci_upper_limit>0.97</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Adverse event data was collected for approximately 30 minutes, including the time while the patient was using the mask and the time immediately after completing the study.</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Linshom</title>
          <description>Linshom Respiratory Monitoring Device: Volunteers will breathe through a continuous positive airway pressure (CPAP) face mask fitted wth the Linshom device. The volunteers will be instructed to breathe normal through the CPAP mask on room air. The excursions of the thermistor tracings (from valley to peak) will be recorded by the Linshom device and displayed continuously on a laptop monitor in a waveform.</description>
        </group>
        <group group_id="E2">
          <title>Maquet Ventilator</title>
          <description>The tidal volume will also be measured by the maquet ventilatorconcurrently and the data downloaded in a Compact Flash card.</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="40"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="40"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="40"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>All Principal Investigators ARE employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Dr. Madhankumar Sathyamoorthy, Principal Investigator</name_or_title>
      <organization>University of Mississippi Medical Center</organization>
      <phone>6018157066</phone>
      <email>msathyamoorthy@umc.edu</email>
    </point_of_contact>
  </clinical_results>
</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/NCT03279458
org study id: 2017-0063
nct id: NCT03279458
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
is unapproved device: Yes
is us export: No
Many post-operative complications arise from patients who breathe inadequately. Inadequate
      respiration, whether the result of surgery or the anesthesia, causes a decrease in blood
      oxygen saturation and an increase in carbon dioxide partial pressure. Both of these surrogate
      measurements of respiration may pose a challenge to measure. Some administer exogenous oxygen
      to all patients as they leave the operating room in order to maintain the blood oxygen
      saturation. This renders the oximeter a less sensitive metric of depressed respiration. In
      the face of decreased respiration, the carbon dioxide levels continue to increase slowly and
      often go undetected unless blood gases are measured. Indeed carbon dioxide blood levels are
      the only metric to detect inadequate ventilation using this surrogate index.

      Monitoring ventilation is a serious challenge outside of critical care settings. In fact,
      there are no monitors available that can measure tidal volume or relative tidal volume
      outside of these settings.

      Linshom is a novel instrument that tracks relative respiration by measuring the excursions of
      the temperature swings between inspiration and expiration and normalizing them to the
      patient's breathing. This monitor may be the first non-invasive monitor to measure relative
      tidal volume in non-critical care settings.

      The purpose of this study is to determine whether a non-invasive, temperature-based
      respiratory instrument can track tidal volume (Vt) in patients.

      The investigators hypothesize that the Linshom device can accurately and consistently track
      tidal volume as measured by closed loop mechanical ventilator.
Forty volunteers will be enrolled in this open label, prospective study to determine the
      correlation between the tidal volumes measured with the Linshom detector and those measured
      with the mechanical ventilator. after Institutional Review Board (IRB) approval and written
      informed consent from the volunteers.

      The Linshom detector, which is comprised of two rapid responding medical-grade thermistors in
      close proximity to the mouth/nose (sensor) and a thermistor remote to the airway, will be
      mounted in the continuous positive airway pressure (CPAP) face mask to measure the
      temperature during breathing. The CPAP will be connected to a Servo-I ventilator (Maquet)
      with a circuit and disposable filter. The volunteers will be instructed to breathe normal
      through the CPAP mask on room air. The excursions of the thermistor tracings (from valley to
      peak) will be recorded by the Linshom device and displayed continuously on a laptop monitor
      in a waveform. The tidal volume will also be measured by the ventilator and the data
      downloaded in a Compact Flash card. The temperature profiles from the sensors and the
      relative tidal volume will be correlated with the tidal volumes measured by the ventilator.
allocation: Non-Randomized
intervention model: Single Group Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: Tidal Volume of Each Breath Was Measured Using the Same Breathing Mask CPAP Apparatus Combined With Respiratory Monitoring Device Allowing for Simultaneous Recording.
time frame: 5 minutes
description: Tidal volume measured by CPAP mask with Lishom respiratory monitoring device. Tidal volume determined from the ventilator will be compared to tidal volume measured by Linshom (calculated indirectly by temperature changes by computer algorithm)
arm group label: Linshom Respiratory Monitoring Device
arm group type: Experimental
description: Volunteers will breathe through a continuous positive airway pressure (CPAP) face mask fitted with the Linshom device. The volunteers will be instructed to breathe normal through the CPAP mask on room air. The excursions of the thermistor tracings (from valley to peak) will be recorded by the Linshom device and displayed continuously on a laptop monitor in a waveform.
arm group label: Ventilator
arm group type: Active Comparator
description: Volunteers will breathe through a continuous positive airway pressure (CPAP) face mask fitted with the Linshom device. The volunteers will be instructed to breathe normal through the CPAP mask on room air.The tidal volume will also be measured by the ventilator and the data downloaded in a Compact Flash card.
intervention type: Device
intervention name: Linshom Respiratory Monitoring Device
description: Volunteers will breathe through a continuous positive airway pressure (CPAP) face mask fitted wth the Linshom device. The volunteers will be instructed to breathe normal through the CPAP mask on room air. The excursions of the thermistor tracings (from valley to peak) will be recorded by the Linshom device and displayed continuously on a laptop monitor in a waveform. The tidal volume will also be measured by the ventilator and the data downloaded in a Compact Flash card.
arm group label: Linshom Respiratory Monitoring Device
arm group label: Ventilator
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Madhankumar Sathyamoorthy, MBBS, MS
role: Principal Investigator
affiliation: Children's of Mississippi/University of Mississippi Medical Center
facility: 
country: United States
url: http://www.asaabstracts.com/strands/asaabstracts/abstract.htm%20%20;jsessionid=682567A35143EC5A44D16DFEEE86493A?year=2015&index=8&absnum=4494
description: A thermodynamic breathing sensor - a new non-invasive monitor of respiration
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PMID: 23871325
citation: Brouillette RT, Morrow AS, Weese-Mayer DE, Hunt CE. Comparison of respiratory inductive plethysmography and thoracic impedance for apnea monitoring. J Pediatr. 1987 Sep;111(3):377-83. doi: 10.1016/s0022-3476(87)80457-2.
PMID: 3625404
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PMID: 23632055
citation: Keidan I, Gravenstein D, Berkenstadt H, Ziv A, Shavit I, Sidi A. Supplemental oxygen compromises the use of pulse oximetry for detection of apnea and hypoventilation during sedation in simulated pediatric patients. Pediatrics. 2008 Aug;122(2):293-8. doi: 10.1542/peds.2007-2385.
PMID: 18676546
citation: Williamson JA, Webb RK, Cockings J, Morgan C. The Australian Incident Monitoring Study. The capnograph: applications and limitations--an analysis of 2000 incident reports. Anaesth Intensive Care. 1993 Oct;21(5):551-7. doi: 10.1177/0310057X9302100510.
PMID: 8273874
citation: Nassi N, Piumelli R, Lombardi E, Landini L, Donzelli G, de Martino M. Comparison between pulse oximetry and transthoracic impedance alarm traces during home monitoring. Arch Dis Child. 2008 Feb;93(2):126-32. doi: 10.1136/adc.2007.118513. Epub 2007 Sep 24.
PMID: 17893118
citation: Kasuya Y, Akca O, Sessler DI, Ozaki M, Komatsu R. Accuracy of postoperative end-tidal Pco2 measurements with mainstream and sidestream capnography in non-obese patients and in obese patients with and without obstructive sleep apnea. Anesthesiology. 2009 Sep;111(3):609-15. doi: 10.1097/ALN.0b013e3181b060b6.
PMID: 19672177
citation: Lerman J, Feldman D, Feldman R, Moser J, Feldman L, Sathyamoorthy M, Deitch K, Feldman U. Linshom respiratory monitoring device: a novel temperature-based respiratory monitor. Can J Anaesth. 2016 Oct;63(10):1154-1160. doi: 10.1007/s12630-016-0694-y. Epub 2016 Jul 13.
PMID: 27412466
responsible party type: Principal Investigator
investigator affiliation: University of Mississippi Medical Center
investigator full name: Madhankumar Sathyamoorthy
investigator title: Associate Professor
sharing ipd: No
ipd description: No plan to share IPD
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 