<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/NCT02256384</url>
  </required_header>
  <id_info>
    <org_study_id>2014-6421</org_study_id>
    <nct_id>NCT02256384</nct_id>
  </id_info>
  <brief_title>Evaluation of Respiratory Acoustic Monitor in Children After Surgery</brief_title>
  <official_title>Evaluation of Respiratory Acoustic Monitor in Children After Surgery</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Children's Hospital Medical Center, Cincinnati</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Masimo Corporation</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
    <collaborator>
      <agency>Children's Medical Center Dallas</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of Texas Southwestern Medical Center</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Children's Hospital Medical Center, Cincinnati</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The study will evaluate the performance of measuring respiration rate with the Respiratory&#xD;
      Acoustic Monitoring (RAM).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The study seeks to determine the reliability and accuracy of the acoustic respiratory&#xD;
      monitoring (RAM) in comparison of clinically completed transthoracic impedance monitoring&#xD;
      (TI) and manual counting of respiratory rate in postoperative pediatric patients at risk of&#xD;
      adverse respiratory events.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 2015</start_date>
  <completion_date type="Actual">August 2015</completion_date>
  <primary_completion_date type="Actual">August 2015</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>Reliability/ Accuracy of Respiratory Acoustic Monitoring (RAM)</measure>
    <time_frame>Up to 24 hours after surgery</time_frame>
    <description>The respiratory acoustic monitor records three vital signs: Respiration rate recorded in breaths per minute, oxygen saturation recorded in percentage, and heart rate recorded in beats per minute.&#xD;
The reliability and accuracy of the respiratory data collected by the RAM was examined by comparing to data collected clinically by the manual counting of the respiratory rate and by the respiratory rate measure by transthoracic impedance . The accuracy of RAM was examined when a staff member goes and register these measurements that occur simultaneously during the first minute of every 2 hour interval to a maximum of a 24 hour monitoring time.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Presence of False Alarms</measure>
    <time_frame>Up to 24 hours after surgery</time_frame>
    <description>To evaluate the presence of false alarms, bedside clinical monitoring was done every two hour during 5 to 15 minutes (random sample) recording the respiratory rates and evaluating the presence of alarms. If an alarm was activated during the bedside monitoring, it was verified by the investigator if the respiratory rate provided by the device was consistent with the clinical evaluation. False alarms were considered those alarms that are triggered by the device, but during simultaneous clinical evaluation it was verified that the number of breaths per minute were inaccurate. Therefore, the higher number of false alarms detected by one type of monitoring indicates that the device is less reliable detecting the respiratory rate.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Tolerance of the RAM</measure>
    <time_frame>Up to 24 hours after surgery</time_frame>
    <description>The tolerance is defined as the ratio of the time the sensor stays in place divided by the total expected time of monitoring, expressed as a percentage. The tolerance to the transthoracic impedance pads was not evaluated during this study considering that this is the standard monitoring and that is usually tolerated during the total expected time of monitoring.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">76</enrollment>
  <condition>Respiratory Complications</condition>
  <condition>Pediatric</condition>
  <arm_group>
    <arm_group_label>Respiratory Acoustic Monitoring</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>All participants will wear the respiratory acoustic monitoring device.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Respiratory Acoustic Monitor</intervention_name>
    <description>Examine the reliability and accuracy of the respiratory acoustic monitor.</description>
    <arm_group_label>Respiratory Acoustic Monitoring</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Male or female children 2 to 16 years of age&#xD;
&#xD;
          -  In-patients or 23 hour short stay patients who had a tonsillectomy with a diagnosis or&#xD;
             symptoms of obstructive sleep apnea or who had any surgery and receiving an opioid by&#xD;
             patient controlled analgesia for post-operative pain control&#xD;
&#xD;
          -  Child weighs at least 10 kg on day of surgery&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patient has skin abnormalities (rash, eczema, etc.) at the planned application sites&#xD;
             that would interfere with sensor or electrode applications.&#xD;
&#xD;
          -  Patient is admitted to the Intensive Care Unit&#xD;
&#xD;
          -  Patient has tracheostomy&#xD;
&#xD;
          -  Patient is on non-invasive ventilator support&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>2 Years</minimum_age>
    <maximum_age>16 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Mario Patino, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Children's Hospital Medical Center, Cincinnati</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Peter Szmuk, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>UT Southwestern Medical Center- Dallas</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Cincinnati Children's Hospital Medical Center</name>
      <address>
        <city>Cincinnati</city>
        <state>Ohio</state>
        <zip>45229</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>UT Southwestern Medical Center - Dallas</name>
      <address>
        <city>Dallas</city>
        <state>Texas</state>
        <zip>75235</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <results_reference>
    <citation>Patino M, Kalin M, Griffin A, Minhajuddin A, Ding L, Williams T, Ishman S, Mahmoud M, Kurth CD, Szmuk P. Comparison of Postoperative Respiratory Monitoring by Acoustic and Transthoracic Impedance Technologies in Pediatric Patients at Risk of Respiratory Depression. Anesth Analg. 2017 Jun;124(6):1937-1942. doi: 10.1213/ANE.0000000000002062.</citation>
    <PMID>28448390</PMID>
  </results_reference>
  <verification_date>September 2020</verification_date>
  <study_first_submitted>October 1, 2014</study_first_submitted>
  <study_first_submitted_qc>October 2, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 3, 2014</study_first_posted>
  <results_first_submitted>August 31, 2020</results_first_submitted>
  <results_first_submitted_qc>September 23, 2020</results_first_submitted_qc>
  <results_first_posted type="Actual">October 19, 2020</results_first_posted>
  <last_update_submitted>September 23, 2020</last_update_submitted>
  <last_update_submitted_qc>September 23, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">October 19, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Respiration Rate</keyword>
  <keyword>Respiratory Acoustic Monitor</keyword>
  <keyword>postoperative</keyword>

  <clinical_results>

    <participant_flow>
      <recruitment_details>Whenever possible, the family will be approached at a pre-surgical clinic visit or contacted by phone the day before recruitment to explain the study. Consent will occur in person at either a clinic visit prior to the day of surgery, in the pre-operative area on the day of surgery, or in the patient's room after surgery.</recruitment_details>
      <group_list>
        <group group_id="P1">
          <title>Respiratory Acoustic Monitoring</title>
          <description>All participants will wear the respiratory acoustic monitoring device. Respiratory Acoustic Monitor: Examine the reliability and accuracy of the respiratory acoustic monitor.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="76"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="62"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="14"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="12"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Equipment not capturing data</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Respiratory Acoustic Monitoring</title>
          <description>All participants will wear the respiratory acoustic monitoring device. Respiratory Acoustic Monitor: Examine the reliability and accuracy of the respiratory acoustic monitor.</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="62"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="62"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="29"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="33"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Reliability/ Accuracy of Respiratory Acoustic Monitoring (RAM)</title>
        <description>The respiratory acoustic monitor records three vital signs: Respiration rate recorded in breaths per minute, oxygen saturation recorded in percentage, and heart rate recorded in beats per minute.&#xD;
The reliability and accuracy of the respiratory data collected by the RAM was examined by comparing to data collected clinically by the manual counting of the respiratory rate and by the respiratory rate measure by transthoracic impedance . The accuracy of RAM was examined when a staff member goes and register these measurements that occur simultaneously during the first minute of every 2 hour interval to a maximum of a 24 hour monitoring time.</description>
        <time_frame>Up to 24 hours after surgery</time_frame>
        <population>62 children from 2 to 16 years old that required postoperatory admission for continuous respiratory monitoring.The respiratory rate was measured and recorded at the same time every 2 hours from the: (a) RAM monitor, (b) thoracic impedance, and (c) manual count over 1 minute. In addition the presence of alarms was also recorded.</population>
        <group_list>
          <group group_id="O1">
            <title>Respiratory Acoustic Monitoring</title>
            <description>All participants will wear the respiratory acoustic monitoring device. Respiratory Acoustic Monitor: Examine the reliability and accuracy of the respiratory acoustic monitor.</description>
          </group>
          <group group_id="O2">
            <title>Manual Counting</title>
            <description>Respiratory rate was recorded by clinical evaluation every 2 hours during the first minute of the evaluation and recorded also simultaneously by RAM and by transthoracic impedance.</description>
          </group>
          <group group_id="O3">
            <title>Transthoracic Impedance</title>
            <description>The respiratory rate was measured by Transthoracic impedance with the use of the electrocardiogram pads.</description>
          </group>
        </group_list>
        <measure>
          <title>Reliability/ Accuracy of Respiratory Acoustic Monitoring (RAM)</title>
          <description>The respiratory acoustic monitor records three vital signs: Respiration rate recorded in breaths per minute, oxygen saturation recorded in percentage, and heart rate recorded in beats per minute.&#xD;
The reliability and accuracy of the respiratory data collected by the RAM was examined by comparing to data collected clinically by the manual counting of the respiratory rate and by the respiratory rate measure by transthoracic impedance . The accuracy of RAM was examined when a staff member goes and register these measurements that occur simultaneously during the first minute of every 2 hour interval to a maximum of a 24 hour monitoring time.</description>
          <population>62 children from 2 to 16 years old that required postoperatory admission for continuous respiratory monitoring.The respiratory rate was measured and recorded at the same time every 2 hours from the: (a) RAM monitor, (b) thoracic impedance, and (c) manual count over 1 minute. In addition the presence of alarms was also recorded.</population>
          <units>Breaths per minute</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="62"/>
                <count group_id="O2" value="62"/>
                <count group_id="O3" value="62"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="19.7" spread="0.52"/>
                    <measurement group_id="O2" value="19.6" spread="0.56"/>
                    <measurement group_id="O3" value="21.3" spread="0.77"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Presence of False Alarms</title>
        <description>To evaluate the presence of false alarms, bedside clinical monitoring was done every two hour during 5 to 15 minutes (random sample) recording the respiratory rates and evaluating the presence of alarms. If an alarm was activated during the bedside monitoring, it was verified by the investigator if the respiratory rate provided by the device was consistent with the clinical evaluation. False alarms were considered those alarms that are triggered by the device, but during simultaneous clinical evaluation it was verified that the number of breaths per minute were inaccurate. Therefore, the higher number of false alarms detected by one type of monitoring indicates that the device is less reliable detecting the respiratory rate.</description>
        <time_frame>Up to 24 hours after surgery</time_frame>
        <population>The presence of alarms and their evaluation as true or false was recorded during 5 to 15 minutes of a fixed interval of every 2 hours.</population>
        <group_list>
          <group group_id="O1">
            <title>Respiratory Acoustic Monitoring</title>
            <description>All participants wore the respiratory acoustic monitoring device. Respiratory Acoustic Monitor: Examine the reliability and accuracy of the respiratory acoustic monitor.</description>
          </group>
          <group group_id="O2">
            <title>Transthoracic Impedance</title>
            <description>All participants wore continuous electrocardiographic monitoring capable of recording respiratory rate continuously and the alarm was set up by defaulted respiratory alarms already selected during the regular clinical practice.</description>
          </group>
        </group_list>
        <measure>
          <title>Presence of False Alarms</title>
          <description>To evaluate the presence of false alarms, bedside clinical monitoring was done every two hour during 5 to 15 minutes (random sample) recording the respiratory rates and evaluating the presence of alarms. If an alarm was activated during the bedside monitoring, it was verified by the investigator if the respiratory rate provided by the device was consistent with the clinical evaluation. False alarms were considered those alarms that are triggered by the device, but during simultaneous clinical evaluation it was verified that the number of breaths per minute were inaccurate. Therefore, the higher number of false alarms detected by one type of monitoring indicates that the device is less reliable detecting the respiratory rate.</description>
          <population>The presence of alarms and their evaluation as true or false was recorded during 5 to 15 minutes of a fixed interval of every 2 hours.</population>
          <units>Number of false alarms per patient</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="62"/>
                <count group_id="O2" value="62"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.18" spread="0.71"/>
                    <measurement group_id="O2" value="1.00" spread="2.78"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Tolerance of the RAM</title>
        <description>The tolerance is defined as the ratio of the time the sensor stays in place divided by the total expected time of monitoring, expressed as a percentage. The tolerance to the transthoracic impedance pads was not evaluated during this study considering that this is the standard monitoring and that is usually tolerated during the total expected time of monitoring.</description>
        <time_frame>Up to 24 hours after surgery</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Respiratory Acoustic Monitoring</title>
            <description>All participants will wear the respiratory acoustic monitoring device. Respiratory Acoustic Monitor: Examine the reliability and accuracy of the respiratory acoustic monitor.</description>
          </group>
        </group_list>
        <measure>
          <title>Tolerance of the RAM</title>
          <description>The tolerance is defined as the ratio of the time the sensor stays in place divided by the total expected time of monitoring, expressed as a percentage. The tolerance to the transthoracic impedance pads was not evaluated during this study considering that this is the standard monitoring and that is usually tolerated during the total expected time of monitoring.</description>
          <units>percentage of time sensor stays in place</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="62"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="87" spread="4.26"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <desc>No serious adverse events were reported related to wearing the monitor sensors. Information regarding skin irritation due to the placement of the sensor was collected just by one of the institutions involved in the study, but was not recorded by the other institution. The total number of participants recruited at the institution that reports the incidence of skin irritation were 30 participants.</desc>
      <group_list>
        <group group_id="E1">
          <title>Respiratory Acoustic Monitoring</title>
          <description>All participants will wear the respiratory acoustic monitoring device. Respiratory Acoustic Monitor: Examine the reliability and accuracy of the respiratory acoustic monitor.</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="62"/>
              </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="4" subjects_at_risk="30"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Skin irritation</sub_title>
                <description>Participants complained of their skin being irritated by the adhesive that is used on the sensors.</description>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="30"/>
              </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>Mario Patino</name_or_title>
      <organization>Cincinnati Children's Hospital Medical Center</organization>
      <phone>513-636-4200</phone>
      <email>mario.patino@cchmc.org</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/NCT02256384
org study id: 2014-6421
nct id: NCT02256384
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
The study will evaluate the performance of measuring respiration rate with the Respiratory
      Acoustic Monitoring (RAM).
The study seeks to determine the reliability and accuracy of the acoustic respiratory
      monitoring (RAM) in comparison of clinically completed transthoracic impedance monitoring
      (TI) and manual counting of respiratory rate in postoperative pediatric patients at risk of
      adverse respiratory events.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: Reliability/ Accuracy of Respiratory Acoustic Monitoring (RAM)
time frame: Up to 24 hours after surgery
description: The respiratory acoustic monitor records three vital signs: Respiration rate recorded in breaths per minute, oxygen saturation recorded in percentage, and heart rate recorded in beats per minute.
The reliability and accuracy of the respiratory data collected by the RAM was examined by comparing to data collected clinically by the manual counting of the respiratory rate and by the respiratory rate measure by transthoracic impedance . The accuracy of RAM was examined when a staff member goes and register these measurements that occur simultaneously during the first minute of every 2 hour interval to a maximum of a 24 hour monitoring time.
measure: Presence of False Alarms
time frame: Up to 24 hours after surgery
description: To evaluate the presence of false alarms, bedside clinical monitoring was done every two hour during 5 to 15 minutes (random sample) recording the respiratory rates and evaluating the presence of alarms. If an alarm was activated during the bedside monitoring, it was verified by the investigator if the respiratory rate provided by the device was consistent with the clinical evaluation. False alarms were considered those alarms that are triggered by the device, but during simultaneous clinical evaluation it was verified that the number of breaths per minute were inaccurate. Therefore, the higher number of false alarms detected by one type of monitoring indicates that the device is less reliable detecting the respiratory rate.
measure: Tolerance of the RAM
time frame: Up to 24 hours after surgery
description: The tolerance is defined as the ratio of the time the sensor stays in place divided by the total expected time of monitoring, expressed as a percentage. The tolerance to the transthoracic impedance pads was not evaluated during this study considering that this is the standard monitoring and that is usually tolerated during the total expected time of monitoring.
arm group label: Respiratory Acoustic Monitoring
arm group type: Experimental
description: All participants will wear the respiratory acoustic monitoring device.
intervention type: Device
intervention name: Respiratory Acoustic Monitor
description: Examine the reliability and accuracy of the respiratory acoustic monitor.
arm group label: Respiratory Acoustic Monitoring
criteria: 
gender: All
minimum age: 2 Years
maximum age: 16 Years
healthy volunteers: No
last name: Mario Patino, MD
role: Principal Investigator
affiliation: Children's Hospital Medical Center, Cincinnati
last name: Peter Szmuk, MD
role: Principal Investigator
affiliation: UT Southwestern Medical Center- Dallas
facility: 
facility: 
country: United States
citation: Patino M, Kalin M, Griffin A, Minhajuddin A, Ding L, Williams T, Ishman S, Mahmoud M, Kurth CD, Szmuk P. Comparison of Postoperative Respiratory Monitoring by Acoustic and Transthoracic Impedance Technologies in Pediatric Patients at Risk of Respiratory Depression. Anesth Analg. 2017 Jun;124(6):1937-1942. doi: 10.1213/ANE.0000000000002062.
PMID: 28448390
responsible party type: Sponsor
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 