<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/NCT03039881</url>
  </required_header>
  <id_info>
    <org_study_id>11544</org_study_id>
    <nct_id>NCT03039881</nct_id>
  </id_info>
  <brief_title>Evaluation of Non-Invasive Respiratory Volume Monitor</brief_title>
  <official_title>Blinded Observational Study to Evaluate a Non-Invasive Respiratory Volume Monitor in the Post-Anesthesia Care Unit and on the General Hospital Floor</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Tufts Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Respiratory Motion, Inc.</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Tufts Medical Center</source>
  <oversight_info>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This observational study investigates the validity and utility of a new, non-significant&#xD;
      risk, FDA approved respiratory monitor, ExSpiron, in the perioperative course of patients&#xD;
      undergoing elective surgery under general anesthesia. The study patients will be monitored&#xD;
      before, during and after surgery, in post-anaesthesia care unit (PACU) and recovery room for&#xD;
      the first post-operative night. The physiologic data will not be used or influence the&#xD;
      standard of care for subjects. It is anticipated that this monitor may be able to improve&#xD;
      perioperative care in the future.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Aim and Hypotheses Currently, there is no objective measure of early respiratory indicators&#xD;
      for developing respiratory compromise in surgical patients. Current respiratory assessment in&#xD;
      non-intubated patients relies on oximetry data and subjective clinical assessment. Pulse&#xD;
      oximetry has been extremely helpful in recognizing oxygen desaturations but it is a late&#xD;
      indicator of respiratory decline. New advances in technology and digital signal processing&#xD;
      have led to the development of an impedance based Respiratory Volume Monitor (RVM). The RVM&#xD;
      (ExSpiron™, Respiratory Motion, Inc.; Waltham, MA) has been shown to provide accurate&#xD;
      real-time, continuous, non-invasive measurements of tidal volume (TV), minute ventilation&#xD;
      (MV) and respiratory rate (RR) in general patient population.&#xD;
&#xD;
      Hypotheses&#xD;
&#xD;
      Primary:&#xD;
&#xD;
      Low minute ventilation (LMV) defined as sustained LMV&lt;40% minute ventilation predicted&#xD;
      (MVPRED) based on IBW following opioid administration correlates with adverse clinical&#xD;
      outcomes in PACU or on the floor including:&#xD;
&#xD;
        -  O2 desaturation, atelectasis, respiratory status requiring advanced monitoring&#xD;
&#xD;
        -  respiratory interventions such as O2 administration, continuous positive airway pressure&#xD;
           CPAP, BiPAP,&#xD;
&#xD;
        -  incidence of ICU transfer and/or increase in PACU and/or general hospital floor (GHF)&#xD;
           length of stay (LOS).&#xD;
&#xD;
      Secondary:&#xD;
&#xD;
        -  1. Decreased MV defined as sustained MV&lt;80% MVPRED based on IBW before opioid&#xD;
           administration correlates with adverse clinical outcomes as defined above.&#xD;
&#xD;
        -  2. Patients with decreased MV prior to opioid administration will be more likely to&#xD;
           develop LMV after standard opioid administration compared to patients with normal MV&#xD;
           defined as MV ≥ 81% MVPRED based on ideal body weight (IBW)&#xD;
&#xD;
      Rationale Continuous respiratory monitoring using the ExSpiron System will be particularly&#xD;
      beneficial to patients in the post-anesthesia environment. Assessment and management of&#xD;
      respiratory function and early intervention when indicated is a multifaceted, complex task&#xD;
      often complicated by the lack of a cohesive and continuous monitoring system to guide&#xD;
      clinical decisions. The ExSpiron system is designed for these patients and is intended to&#xD;
      address some of the limitations of the current generation of hospital monitors and to provide&#xD;
      healthcare providers with continuous real-time data regarding the patient's respiratory&#xD;
      status. Recent data has shown that stratification of patients based on the RVM's MV as % of&#xD;
      predicted MV (MVPRED), prior to opioid dosing has made it possible to identify patients who&#xD;
      are at risk for further decreases in MV and opioid-induced respiratory depression (OIRD).&#xD;
&#xD;
        1. In the spontaneously breathing, non-ventilated patient, current monitoring devices do&#xD;
           not provide continuous, objective non-invasive, continuous real time information of the&#xD;
           important respiratory parameters TV, MV &amp; RR.&#xD;
&#xD;
        2. Current monitoring of non-intubated patients mostly relies on subjective clinical&#xD;
           assessment, oximetry data, and rarely end-tidal carbon dioxide CO2 measurements. In&#xD;
           appropriate clinical settings, the ExSpiron system can provide direct quantitative&#xD;
           measure of ventilation parameters for use in clinical assessment and trend prediction as&#xD;
           well as response to medications and other interventions to allow for more efficient&#xD;
           clinical decision making.&#xD;
&#xD;
        3. Current technologies do not provide for a continuity of care between the PACU and the&#xD;
           general hospital floor.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 9, 2015</start_date>
  <completion_date type="Actual">January 8, 2019</completion_date>
  <primary_completion_date type="Actual">January 8, 2019</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>Low minute ventilation</measure>
    <time_frame>Post-operatively in PACU and general patient' floor up to 24 hours after completion of surgery</time_frame>
    <description>Low minute ventilation (LMV) defined as sustained LMV&lt;40% minute ventilation predicted (MVPRED) based on IBW following opioid administration correlates with adverse clinical outcomes in PACU and on the floor</description>
  </primary_outcome>
  <enrollment type="Actual">150</enrollment>
  <condition>Monitoring for Low Minute Ventilation Post Surgery</condition>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Non-Invasive Respiratory Volume Monitor</intervention_name>
    <description>The device requires the application of a monitoring PadSets to the patient's skin similar to EKG electrodes and, as such, poses minimal risk.</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Adult patients undergoing elective surgery with general anesthesia&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adult patients undergoing surgery with general anesthesia and positive pressure&#xD;
             ventilation, patient's ≥80 pounds and who are able to give informed consent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients unable to give informed consent. Any patient whose condition or procedure&#xD;
             will not allow for placement of the electrode PadSet&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Iwona Bonney, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Tufts Medical Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Tufts Medical Center</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02111</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>January 27, 2017</study_first_submitted>
  <study_first_submitted_qc>January 30, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">February 1, 2017</study_first_posted>
  <last_update_submitted>January 8, 2019</last_update_submitted>
  <last_update_submitted_qc>January 8, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 9, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Minute ventilation, ExSpiron monitor</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/NCT03039881
org study id: 11544
nct id: NCT03039881
lead sponsor: 
collaborator: 
is fda regulated device: Yes
This observational study investigates the validity and utility of a new, non-significant
      risk, FDA approved respiratory monitor, ExSpiron, in the perioperative course of patients
      undergoing elective surgery under general anesthesia. The study patients will be monitored
      before, during and after surgery, in post-anaesthesia care unit (PACU) and recovery room for
      the first post-operative night. The physiologic data will not be used or influence the
      standard of care for subjects. It is anticipated that this monitor may be able to improve
      perioperative care in the future.
Aim and Hypotheses Currently, there is no objective measure of early respiratory indicators
      for developing respiratory compromise in surgical patients. Current respiratory assessment in
      non-intubated patients relies on oximetry data and subjective clinical assessment. Pulse
      oximetry has been extremely helpful in recognizing oxygen desaturations but it is a late
      indicator of respiratory decline. New advances in technology and digital signal processing
      have led to the development of an impedance based Respiratory Volume Monitor (RVM). The RVM
      (ExSpiron™, Respiratory Motion, Inc.; Waltham, MA) has been shown to provide accurate
      real-time, continuous, non-invasive measurements of tidal volume (TV), minute ventilation
      (MV) and respiratory rate (RR) in general patient population.

      Hypotheses

      Primary:

      Low minute ventilation (LMV) defined as sustained LMV<40% minute ventilation predicted
      (MVPRED) based on IBW following opioid administration correlates with adverse clinical
      outcomes in PACU or on the floor including:

        -  O2 desaturation, atelectasis, respiratory status requiring advanced monitoring

        -  respiratory interventions such as O2 administration, continuous positive airway pressure
           CPAP, BiPAP,

        -  incidence of ICU transfer and/or increase in PACU and/or general hospital floor (GHF)
           length of stay (LOS).

      Secondary:

        -  1. Decreased MV defined as sustained MV<80% MVPRED based on IBW before opioid
           administration correlates with adverse clinical outcomes as defined above.

        -  2. Patients with decreased MV prior to opioid administration will be more likely to
           develop LMV after standard opioid administration compared to patients with normal MV
           defined as MV ≥ 81% MVPRED based on ideal body weight (IBW)

      Rationale Continuous respiratory monitoring using the ExSpiron System will be particularly
      beneficial to patients in the post-anesthesia environment. Assessment and management of
      respiratory function and early intervention when indicated is a multifaceted, complex task
      often complicated by the lack of a cohesive and continuous monitoring system to guide
      clinical decisions. The ExSpiron system is designed for these patients and is intended to
      address some of the limitations of the current generation of hospital monitors and to provide
      healthcare providers with continuous real-time data regarding the patient's respiratory
      status. Recent data has shown that stratification of patients based on the RVM's MV as % of
      predicted MV (MVPRED), prior to opioid dosing has made it possible to identify patients who
      are at risk for further decreases in MV and opioid-induced respiratory depression (OIRD).

        1. In the spontaneously breathing, non-ventilated patient, current monitoring devices do
           not provide continuous, objective non-invasive, continuous real time information of the
           important respiratory parameters TV, MV & RR.

        2. Current monitoring of non-intubated patients mostly relies on subjective clinical
           assessment, oximetry data, and rarely end-tidal carbon dioxide CO2 measurements. In
           appropriate clinical settings, the ExSpiron system can provide direct quantitative
           measure of ventilation parameters for use in clinical assessment and trend prediction as
           well as response to medications and other interventions to allow for more efficient
           clinical decision making.

        3. Current technologies do not provide for a continuity of care between the PACU and the
           general hospital floor.
observational model: Cohort
time perspective: Prospective
measure: Low minute ventilation
time frame: Post-operatively in PACU and general patient' floor up to 24 hours after completion of surgery
description: Low minute ventilation (LMV) defined as sustained LMV<40% minute ventilation predicted (MVPRED) based on IBW following opioid administration correlates with adverse clinical outcomes in PACU and on the floor
intervention type: Device
intervention name: Non-Invasive Respiratory Volume Monitor
description: The device requires the application of a monitoring PadSets to the patient's skin similar to EKG electrodes and, as such, poses minimal risk.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Iwona Bonney, PhD
role: Principal Investigator
affiliation: Tufts Medical Center
facility: 
country: United States
responsible party type: Sponsor
sharing ipd: No