<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/NCT04407806</url>
  </required_header>
  <id_info>
    <org_study_id>2020-016</org_study_id>
    <nct_id>NCT04407806</nct_id>
  </id_info>
  <brief_title>Utility of Continuous Pulse Oximetry for Pediatric Patients With Stable Respiratory Illness</brief_title>
  <official_title>Utility of Continuous Pulse Oximetry for Pediatric Patients With Stable Respiratory Illness</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>William Beaumont Hospitals</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>William Beaumont Hospitals</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_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a randomized, prospective study to determine if there is a difference in hospital&#xD;
      length of stay between patients receiving continuous hardwire cardiorespiratory monitoring&#xD;
      and those receiving intermittent vital signs measurements among pediatric patients admitted&#xD;
      for uncomplicated respiratory illness.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Respiratory illnesses are among the most common causes for inpatient pediatric&#xD;
      hospitalizations every year. The most common respiratory illnesses that make up these&#xD;
      hospitalizations include pneumonia, acute bronchiolitis, and asthma.&#xD;
&#xD;
      Pneumonia is one of the top three illnesses requiring pediatric hospitalization and is a&#xD;
      significant cause or morbidity and mortality. The incidence of pediatric pneumonia varies&#xD;
      depending on the country and age group, but worldwide the annual incidence in children&#xD;
      younger than five years of age is 150 million and approximately 2 million pediatric deaths,&#xD;
      per year, are attributed to pneumonia. Therefore, it is important to understand this disease&#xD;
      and how it impacts pediatric hospital admissions.&#xD;
&#xD;
      Pneumonia is defined as an acute infection of the lung parenchyma secondary to an infectious&#xD;
      etiology such as viruses or bacteria. When an infectious organism is present, the defense&#xD;
      mechanisms of the body, including the lungs, are disturbed and the resultant inflammation&#xD;
      gives rise to parenchymal damage. Symptoms can include fever, cough, and shortness of breath.&#xD;
      Findings on imaging can demonstrate infiltrates in the lungs. Vital sign testing can show&#xD;
      elevations in a child's heart rate and decreases in the amount of oxygen present in the blood&#xD;
      (pulse oximetry) secondary to the infiltrative processes in the lungs.&#xD;
&#xD;
      Pneumonia is the most common serious infection in the pediatric population and accounts for&#xD;
      up to 1-4% of all pediatric Emergency Department (ED) visits in the United States (US).&#xD;
      Furthermore, of the pediatric patients that present to the ED with pneumonia, 20-25% are&#xD;
      admitted to the inpatient pediatric unit for further management. This decision to admit a&#xD;
      child to the hospital depends on various underlying factors including age, medical&#xD;
      conditions, and severity of illness. One of the factors that is considered when deciding&#xD;
      whether to admit a child to the hospital for pneumonia is oxygen saturation, or the amount of&#xD;
      oxygen in the blood.&#xD;
&#xD;
      Bronchiolitis is another common respiratory illness in the pediatric population and is&#xD;
      estimated to account for up to 100,000 US hospital admissions annually. There is a&#xD;
      seasonality with most infections occurring in the fall and winter months. It is the leading&#xD;
      cause of hospitalization in infants and young children with most cases involving children&#xD;
      less than two years of age.&#xD;
&#xD;
      Acute bronchiolitis refers to lower airway inflammation and obstruction secondary to a viral&#xD;
      infection. When a virus infects the terminal bronchiolar epithelial cells of the lower&#xD;
      airways in the lungs, damage to these cells results and subsequently causes cellular&#xD;
      sloughing and inflammation. This inflammation, coupled with mucous build-up, accounts for the&#xD;
      obstruction that is seen in acute bronchiolitis. Symptoms include rhinitis, congestion,&#xD;
      cough, tachypnea, wheezing, and accessory muscle use. Like pneumonia, hypoxemia (decreased&#xD;
      oxygen content in the blood) can occur with acute bronchiolitis with the most severe&#xD;
      complication being acute respiratory failure requiring mechanical ventilation.&#xD;
&#xD;
      The third most common respiratory illness that accounts for pediatric hospital admissions is&#xD;
      asthma. Asthma affects 1 in 12 children in the US and is a leading cause of ED visits. It is&#xD;
      the most common chronic disease in childhood in developed countries and an estimated 8.3% of&#xD;
      children in the US had been diagnosed with asthma in 2016.&#xD;
&#xD;
      Asthma is a complex, multifactorial, immune-mediated disease and is defined by episodic and&#xD;
      reversible airway constriction and inflammation. Triggers for asthma exacerbations can&#xD;
      include infections, environmental allergens, and other irritants. Smooth muscle constriction&#xD;
      in the airways and inflammation/edema result in intermittent and reversible lower airway&#xD;
      obstructions. Symptoms of asthma include cough, wheezing, shortness of breath, and chest&#xD;
      tightness. Like the other respiratory illnesses mentioned, asthma can also result in&#xD;
      hypoxemia.&#xD;
&#xD;
      Respiratory illnesses, including pneumonia, acute bronchiolitis, and pneumonia pose a&#xD;
      significant threat to the pediatric population and are major causes of morbidity and&#xD;
      mortality throughout the world. In the US, most pediatric hospital admissions are secondary&#xD;
      to these illnesses and determining how to best monitor and manage these patients while in the&#xD;
      hospital is important. Specifically, the most ideal technique to monitor for hypoxemia is one&#xD;
      of current debate.&#xD;
&#xD;
      Currently, there are two main ways to monitor for hypoxemia in a hospital setting. The first&#xD;
      is to have a pediatric patient on continuous monitoring, which involves the child being&#xD;
      continuously connected to a monitor that displays various vital signs, one of which being&#xD;
      oxygen saturation (SpO2). This technique has been studied over the last several years and&#xD;
      many concerns have been raised regarding alarm fatigue, or the phenomenon that occurs when a&#xD;
      patient is continuously connected to a monitor and the monitor alarms an overwhelming amount.&#xD;
      One study found that this form of monitoring was used in up to 50% of children in non-ICU&#xD;
      settings and that up to 99% of the alarms did not require clinical action. In fact, this&#xD;
      study found that more than 10,000 alarms can occur in a pediatric unit in 1 week and that&#xD;
      greater than 150 alarms can occur on any one patient each day. Furthermore, while these&#xD;
      continuous monitors are meant to identify patients who are deteriorating, it has been&#xD;
      suggested that the efficacy is limited by alarm fatigue and that evidence has not shown them&#xD;
      to improve patient outcomes. Finally, a recent study also demonstrated that the second form&#xD;
      of monitoring, scheduled vital checks, may be superior to electronic measurements when&#xD;
      assessing patients for deterioration. Currently, there are no guidelines to recommend what&#xD;
      form of monitoring, continuous monitoring or scheduled vital checks, is superior and studies&#xD;
      evaluating the rationale behind widespread continuous monitoring techniques are lacking.&#xD;
&#xD;
      This study will determine if there is a difference in hospital length of stay between&#xD;
      pediatric patients admitted for uncomplicated respiratory illnesses receiving continuous&#xD;
      hardwire cardiorespiratory monitoring and those receiving intermittent vital signs&#xD;
      measurements. Patients will be randomized to two groups. One group will be comprised of&#xD;
      patients receiving continuous hardwire monitoring during the entire stay in the hospital. The&#xD;
      other group will be comprised of patients receiving intermittent vital signs measurements&#xD;
      (heart rate, respiratory rate, blood pressure, oxygen saturation, and temperature) every four&#xD;
      hours, per standard of care on the pediatric unit.&#xD;
&#xD;
      Data will be collected on supplemental oxygen use and patients' level of oxygen saturation&#xD;
      throughout the hospital stay. On day of hospital discharge, up to 14 days, parents or&#xD;
      guardians will be asked to complete the Parent Study Questionnaire, to assess parental rating&#xD;
      of the level of care their child received in hospitalization and parental comfort level with&#xD;
      continuing to care for their child at home.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 24, 2020</start_date>
  <completion_date type="Actual">June 2, 2021</completion_date>
  <primary_completion_date type="Actual">May 1, 2021</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>Randomized, Prospective, single-site</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Length of Stay, Measured in Days</measure>
    <time_frame>Duration of length of stay, up to 14 days</time_frame>
    <description>The start time for measurement of the length of stay will be when the order for either vitals checks or hardwire monitoring is entered in the computer. The end time for measurement of length of stay will be when the discharge order is entered into the computer system.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Comfort of Parents: Level of Care Their Child Received in Hospital</measure>
    <time_frame>On day of hospital discharge, up to 14 days</time_frame>
    <description>Parental rating of care received in hospital, as measured by &quot;Parent Study Questionnaire&quot;,using Likert scale, where 5 represents &quot;My child received excellent care&quot; and 1 represents &quot;My child received very poor care&quot;. A higher score represents a better outcome.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Comfort of Parents: Continuing to Care for Their Child at Home</measure>
    <time_frame>On day of hospital discharge, up to 14 days</time_frame>
    <description>Comfort level of parents as measured by &quot;Parent Study Questionnaire&quot;, using Likert scale where 5 represents &quot;very comfortable with continuing to care for child at home&quot; and 1 represents &quot;very uncomfortable with continuing care for child at home.&quot; A higher score represents a better outcome</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Frequency of Nurse Responses to Pulse Oximetry Alarms</measure>
    <time_frame>Duration of length of stay, up to 14 days</time_frame>
    <description>Number of times nurses respond to pulse oximetry alarms, tabulated per patient</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Frequency of Pulse Oximetry Alarms Require Medical Intervention</measure>
    <time_frame>Duration of length of stay, up to 14 days</time_frame>
    <description>Number of pulse oximetry alarms requiring intervention by nurses, tabulated per patient</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">6</enrollment>
  <condition>Respiratory Disease</condition>
  <condition>Asthma in Children</condition>
  <condition>Pneumonia in Children</condition>
  <condition>Bronchiolitis Acute</condition>
  <arm_group>
    <arm_group_label>Continuous Pulse Oximetry Monitoring of Oxygen Saturation</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Continuous pulse oximetry to measure oxygen saturation</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Intermittent Pulse Oximetry Monitoring of Oxygen Saturation</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Intermittent pulse oximetry to measure oxygen saturation, measured every 4 hours</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Continous Pulse oximeter</intervention_name>
    <description>Pulse oximeter is a small lightweight non-invasive device placed on the fingertip or toe to measure blood oxygen saturation throughout hospitalization</description>
    <arm_group_label>Continuous Pulse Oximetry Monitoring of Oxygen Saturation</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Intermittent Pulse oximeter</intervention_name>
    <description>Pulse oximeter is a small lightweight non-invasive device placed on the fingertip or toe to measure blood oxygen saturation intermittently during hospitalization</description>
    <arm_group_label>Intermittent Pulse Oximetry Monitoring of Oxygen Saturation</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Admission for respiratory illness&#xD;
&#xD;
          -  Corrected gestational age greater than 3 months&#xD;
&#xD;
          -  Age less than or equal to 14 years old&#xD;
&#xD;
          -  Admission to Beaumont children's Hospital Pediatric unit, or transfer to pediatric&#xD;
             unit from the Beaumont Children's hospital&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Primary admission from non-respiratory illness&#xD;
&#xD;
          -  Corrected gestational age less than 3 months&#xD;
&#xD;
          -  Age greater thn 14 years ld&#xD;
&#xD;
          -  History of chronic lung disease and age less than 1 year&#xD;
&#xD;
          -  Home oxygen use&#xD;
&#xD;
          -  Tracheostomy dependent&#xD;
&#xD;
          -  Neuro-muscular disease of hypotonia secondary to chronic/congenital disease&#xD;
&#xD;
          -  Cardiac malformation treated with medicatio&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>3 Months</minimum_age>
    <maximum_age>14 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Graham Krasan, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Beaumont Health</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Beaumont Hospital - Royal Oak</name>
      <address>
        <city>Royal Oak</city>
        <state>Michigan</state>
        <zip>48073</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Ernst KD; COMMITTEE ON HOSPITAL CARE. Resources Recommended for the Care of Pediatric Patients in Hospitals. Pediatrics. 2020 Apr;145(4):e20200204. doi: 10.1542/peds.2020-0204. Epub 2020 Mar 23.</citation>
    <PMID>32205465</PMID>
  </reference>
  <reference>
    <citation>Barson, W. J., MD. (2019, September 25). Community-acquired pneumonia in children: Clinical features and diagnosis. Retrieved April 13, 2020, from https://www.uptodate.com/contents/community-acquired-pneumonia-in-children-clinical-features-and-diagnosis?search=pneumonia</citation>
  </reference>
  <reference>
    <citation>Jain V, Bhardwaj A. Pneumonia pathology. StatPearls. 2020.</citation>
  </reference>
  <reference>
    <citation>Williams DJ, Zhu Y, Grijalva CG, Self WH, Harrell FE Jr, Reed C, Stockmann C, Arnold SR, Ampofo KK, Anderson EJ, Bramley AM, Wunderink RG, McCullers JA, Pavia AT, Jain S, Edwards KM. Predicting Severe Pneumonia Outcomes in Children. Pediatrics. 2016 Oct;138(4):e20161019. doi: 10.1542/peds.2016-1019.</citation>
    <PMID>27688362</PMID>
  </reference>
  <reference>
    <citation>Gereige RS, Laufer PM. Pneumonia. Pediatr Rev. 2013 Oct;34(10):438-56; quiz 455-6. doi: 10.1542/pir.34-10-438. No abstract available. Erratum In: Pediatr Rev. 2014 Jan;35(1):29. Dosage error in article text.</citation>
    <PMID>24085792</PMID>
  </reference>
  <reference>
    <citation>Silver AH, Nazif JM. Bronchiolitis. Pediatr Rev. 2019 Nov;40(11):568-576. doi: 10.1542/pir.2018-0260. No abstract available.</citation>
    <PMID>31676530</PMID>
  </reference>
  <reference>
    <citation>Piedra, P. A., MD, &amp; Stark, A. R., MD. (2020, March 9). Bronchiolitis in infants and children: Clinical features and diagnosis. Retrieved April 13, 2020, from https://www.uptodate.com/contents/bronchiolitis-in-infants-and-children-clinical-features-and-diagnosis?search=bronchiolitis</citation>
  </reference>
  <reference>
    <citation>Patel SJ, Teach SJ. Asthma. Pediatr Rev. 2019 Nov;40(11):549-567. doi: 10.1542/pir.2018-0282. No abstract available.</citation>
    <PMID>31676529</PMID>
  </reference>
  <reference>
    <citation>Sawicki, G., MD, &amp; Haver, K., MD. (2018, November 16). Asthma in children younger than 12 years: Initial evaluation and diagnosis. Retrieved April 13, 2020, from https://www.uptodate.com/contents/asthma-in-children-younger-than-12-years-initial-evaluation-and-diagnosis?search=asthma</citation>
  </reference>
  <reference>
    <citation>Schondelmeyer AC, Jenkins AM, Allison B, Timmons KM, Loechtenfeldt AM, Pope-Smyth ST, Vaughn LM. Factors Influencing Use of Continuous Physiologic Monitors for Hospitalized Pediatric Patients. Hosp Pediatr. 2019 Jun;9(6):423-428. doi: 10.1542/hpeds.2019-0007. Epub 2019 May 1.</citation>
    <PMID>31043435</PMID>
  </reference>
  <verification_date>February 2022</verification_date>
  <study_first_submitted>April 14, 2020</study_first_submitted>
  <study_first_submitted_qc>May 27, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">May 29, 2020</study_first_posted>
  <results_first_submitted>January 21, 2022</results_first_submitted>
  <results_first_submitted_qc>February 15, 2022</results_first_submitted_qc>
  <results_first_posted type="Actual">March 10, 2022</results_first_posted>
  <last_update_submitted>February 15, 2022</last_update_submitted>
  <last_update_submitted_qc>February 15, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">March 10, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>William Beaumont Hospitals</investigator_affiliation>
    <investigator_full_name>Graham Krasan, MD</investigator_full_name>
    <investigator_title>Staff Pediatrician, Infectious Disease Specialty</investigator_title>
  </responsible_party>
  <keyword>Pulse oximetry</keyword>
  <keyword>Oxygen saturation</keyword>
  <keyword>Hypoxia</keyword>
  <keyword>Blood oxygen level</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Bronchiolitis</mesh_term>
    <mesh_term>Respiratory Tract Diseases</mesh_term>
    <mesh_term>Respiration Disorders</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>November 30, 2020</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/06/NCT04407806/Prot_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Continuous Pulse Oximetry Monitoring of Oxygen Saturation</title>
          <description>Continuous pulse oximetry to measure oxygen saturation&#xD;
Continous Pulse oximeter: Pulse oximeter is a small lightweight non-invasive device placed on the fingertip or toe to measure blood oxygen saturation throughout hospitalization</description>
        </group>
        <group group_id="P2">
          <title>Intermittent Pulse Oximetry Monitoring of Oxygen Saturation</title>
          <description>Intermittent pulse oximetry to measure oxygen saturation, measured every 4 hours&#xD;
Intermittent Pulse oximeter: Pulse oximeter is a small lightweight non-invasive device placed on the fingertip or toe to measure blood oxygen saturation intermittently during hospitalization</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
                <participants group_id="P2" count="3"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="2"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Continuous Pulse Oximetry Monitoring of Oxygen Saturation</title>
          <description>Continuous pulse oximetry to measure oxygen saturation&#xD;
Continous Pulse oximeter: Pulse oximeter is a small lightweight non-invasive device placed on the fingertip or toe to measure blood oxygen saturation throughout hospitalization</description>
        </group>
        <group group_id="B2">
          <title>Intermittent Pulse Oximetry Monitoring of Oxygen Saturation</title>
          <description>Intermittent pulse oximetry to measure oxygen saturation, measured every 4 hours&#xD;
Intermittent Pulse oximeter: Pulse oximeter is a small lightweight non-invasive device placed on the fingertip or toe to measure blood oxygen saturation intermittently during hospitalization</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="3"/>
            <count group_id="B2" value="3"/>
            <count group_id="B3" value="6"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <description>measure reported in years with ages less then 2 years expressed a decimal number of years</description>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Full Range</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="3"/>
                    <count group_id="B2" value="3"/>
                    <count group_id="B3" value="6"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="10" lower_limit="6" upper_limit="14"/>
                    <measurement group_id="B2" value="1.64" lower_limit="1.58" upper_limit="1.75"/>
                    <measurement group_id="B3" value="6.15" lower_limit="1.58" upper_limit="14"/>
                  </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>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="3"/>
                    <count group_id="B2" value="3"/>
                    <count group_id="B3" value="6"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="6"/>
                  </measurement_list>
                </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 group_id="B2" value="0"/>
                    <count group_id="B3" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_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="3"/>
                    <count group_id="B2" value="3"/>
                    <count group_id="B3" value="6"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Length of Stay, Measured in Days</title>
        <description>The start time for measurement of the length of stay will be when the order for either vitals checks or hardwire monitoring is entered in the computer. The end time for measurement of length of stay will be when the discharge order is entered into the computer system.</description>
        <time_frame>Duration of length of stay, up to 14 days</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Continuous Pulse Oximetry Monitoring of Oxygen Saturation</title>
            <description>Continuous pulse oximetry to measure oxygen saturation&#xD;
Continous Pulse oximeter: Pulse oximeter is a small lightweight non-invasive device placed on the fingertip or toe to measure blood oxygen saturation throughout hospitalization</description>
          </group>
          <group group_id="O2">
            <title>Intermittent Pulse Oximetry Monitoring of Oxygen Saturation</title>
            <description>Intermittent pulse oximetry to measure oxygen saturation, measured every 4 hours&#xD;
Intermittent Pulse oximeter: Pulse oximeter is a small lightweight non-invasive device placed on the fingertip or toe to measure blood oxygen saturation intermittently during hospitalization</description>
          </group>
        </group_list>
        <measure>
          <title>Length of Stay, Measured in Days</title>
          <description>The start time for measurement of the length of stay will be when the order for either vitals checks or hardwire monitoring is entered in the computer. The end time for measurement of length of stay will be when the discharge order is entered into the computer system.</description>
          <units>days</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="3"/>
                <count group_id="O2" value="3"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.15" spread=".20"/>
                    <measurement group_id="O2" value="1.04" spread=".54"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Comfort of Parents: Level of Care Their Child Received in Hospital</title>
        <description>Parental rating of care received in hospital, as measured by &quot;Parent Study Questionnaire&quot;,using Likert scale, where 5 represents &quot;My child received excellent care&quot; and 1 represents &quot;My child received very poor care&quot;. A higher score represents a better outcome.</description>
        <time_frame>On day of hospital discharge, up to 14 days</time_frame>
        <population>Only 3 participants' parents completed the survey. Only 3 participants data was analyzed for this secondary outcome measure (2 continuous pulse oximetry monitoring participants and 1 intermittent pulse oximetry participant). Parents were not considered enrolled but did contribute to this assessment. Parents were not considered enrolled but did contribute to this assessment.</population>
        <group_list>
          <group group_id="O1">
            <title>Continuous Pulse Oximetry Monitoring of Oxygen Saturation</title>
            <description>Continuous pulse oximetry to measure oxygen saturation&#xD;
Continous Pulse oximeter: Pulse oximeter is a small lightweight non-invasive device placed on the fingertip or toe to measure blood oxygen saturation throughout hospitalization</description>
          </group>
          <group group_id="O2">
            <title>Intermittent Pulse Oximetry Monitoring of Oxygen Saturation</title>
            <description>Intermittent pulse oximetry to measure oxygen saturation, measured every 4 hours&#xD;
Intermittent Pulse oximeter: Pulse oximeter is a small lightweight non-invasive device placed on the fingertip or toe to measure blood oxygen saturation intermittently during hospitalization</description>
          </group>
        </group_list>
        <measure>
          <title>Comfort of Parents: Level of Care Their Child Received in Hospital</title>
          <description>Parental rating of care received in hospital, as measured by &quot;Parent Study Questionnaire&quot;,using Likert scale, where 5 represents &quot;My child received excellent care&quot; and 1 represents &quot;My child received very poor care&quot;. A higher score represents a better outcome.</description>
          <population>Only 3 participants' parents completed the survey. Only 3 participants data was analyzed for this secondary outcome measure (2 continuous pulse oximetry monitoring participants and 1 intermittent pulse oximetry participant). Parents were not considered enrolled but did contribute to this assessment. Parents were not considered enrolled but did contribute to this assessment.</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="2"/>
                <count group_id="O2" value="1"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5" lower_limit="5" upper_limit="5"/>
                    <measurement group_id="O2" value="5" lower_limit="5" upper_limit="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Comfort of Parents: Continuing to Care for Their Child at Home</title>
        <description>Comfort level of parents as measured by &quot;Parent Study Questionnaire&quot;, using Likert scale where 5 represents &quot;very comfortable with continuing to care for child at home&quot; and 1 represents &quot;very uncomfortable with continuing care for child at home.&quot; A higher score represents a better outcome</description>
        <time_frame>On day of hospital discharge, up to 14 days</time_frame>
        <population>Only 3 participants' parents completed the survey. Only 3 participants data was analyzed for this secondary outcome measure (2 continuous pulse oximetry monitoring participants and 1 intermittent pulse oximetry participant). Parents were not considered enrolled but did contribute to this assessment.</population>
        <group_list>
          <group group_id="O1">
            <title>Continuous Pulse Oximetry Monitoring of Oxygen Saturation</title>
            <description>Continuous pulse oximetry to measure oxygen saturation&#xD;
Continous Pulse oximeter: Pulse oximeter is a small lightweight non-invasive device placed on the fingertip or toe to measure blood oxygen saturation throughout hospitalization</description>
          </group>
          <group group_id="O2">
            <title>Intermittent Pulse Oximetry Monitoring of Oxygen Saturation</title>
            <description>Intermittent pulse oximetry to measure oxygen saturation, measured every 4 hours&#xD;
Intermittent Pulse oximeter: Pulse oximeter is a small lightweight non-invasive device placed on the fingertip or toe to measure blood oxygen saturation intermittently during hospitalization</description>
          </group>
        </group_list>
        <measure>
          <title>Comfort of Parents: Continuing to Care for Their Child at Home</title>
          <description>Comfort level of parents as measured by &quot;Parent Study Questionnaire&quot;, using Likert scale where 5 represents &quot;very comfortable with continuing to care for child at home&quot; and 1 represents &quot;very uncomfortable with continuing care for child at home.&quot; A higher score represents a better outcome</description>
          <population>Only 3 participants' parents completed the survey. Only 3 participants data was analyzed for this secondary outcome measure (2 continuous pulse oximetry monitoring participants and 1 intermittent pulse oximetry participant). Parents were not considered enrolled but did contribute to this assessment.</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="2"/>
                <count group_id="O2" value="1"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5" lower_limit="5" upper_limit="5"/>
                    <measurement group_id="O2" value="3" lower_limit="3" upper_limit="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Frequency of Nurse Responses to Pulse Oximetry Alarms</title>
        <description>Number of times nurses respond to pulse oximetry alarms, tabulated per patient</description>
        <time_frame>Duration of length of stay, up to 14 days</time_frame>
        <population>Data was not collected, data was not analyzed for any participants.</population>
        <group_list>
          <group group_id="O1">
            <title>Continuous Pulse Oximetry Monitoring of Oxygen Saturation</title>
            <description>Continuous pulse oximetry to measure oxygen saturation&#xD;
Continous Pulse oximeter: Pulse oximeter is a small lightweight non-invasive device placed on the fingertip or toe to measure blood oxygen saturation throughout hospitalization</description>
          </group>
          <group group_id="O2">
            <title>Intermittent Pulse Oximetry Monitoring of Oxygen Saturation</title>
            <description>Intermittent pulse oximetry to measure oxygen saturation, measured every 4 hours&#xD;
Intermittent Pulse oximeter: Pulse oximeter is a small lightweight non-invasive device placed on the fingertip or toe to measure blood oxygen saturation intermittently during hospitalization</description>
          </group>
        </group_list>
        <measure>
          <title>Frequency of Nurse Responses to Pulse Oximetry Alarms</title>
          <description>Number of times nurses respond to pulse oximetry alarms, tabulated per patient</description>
          <population>Data was not collected, data was not analyzed for any participants.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Frequency of Pulse Oximetry Alarms Require Medical Intervention</title>
        <description>Number of pulse oximetry alarms requiring intervention by nurses, tabulated per patient</description>
        <time_frame>Duration of length of stay, up to 14 days</time_frame>
        <population>Data was not collected, data was not analyzed for any participants.</population>
        <group_list>
          <group group_id="O1">
            <title>Continuous Pulse Oximetry Monitoring of Oxygen Saturation</title>
            <description>Continuous pulse oximetry to measure oxygen saturation&#xD;
Continous Pulse oximeter: Pulse oximeter is a small lightweight non-invasive device placed on the fingertip or toe to measure blood oxygen saturation throughout hospitalization</description>
          </group>
          <group group_id="O2">
            <title>Intermittent Pulse Oximetry Monitoring of Oxygen Saturation</title>
            <description>Intermittent pulse oximetry to measure oxygen saturation, measured every 4 hours&#xD;
Intermittent Pulse oximeter: Pulse oximeter is a small lightweight non-invasive device placed on the fingertip or toe to measure blood oxygen saturation intermittently during hospitalization</description>
          </group>
        </group_list>
        <measure>
          <title>Frequency of Pulse Oximetry Alarms Require Medical Intervention</title>
          <description>Number of pulse oximetry alarms requiring intervention by nurses, tabulated per patient</description>
          <population>Data was not collected, data was not analyzed for any participants.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Duration of length of stay, up to 14 days (up to 14 days)</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Continuous Pulse Oximetry Monitoring of Oxygen Saturation</title>
          <description>Continuous pulse oximetry to measure oxygen saturation&#xD;
Continous Pulse oximeter: Pulse oximeter is a small lightweight non-invasive device placed on the fingertip or toe to measure blood oxygen saturation throughout hospitalization</description>
        </group>
        <group group_id="E2">
          <title>Intermittent Pulse Oximetry Monitoring of Oxygen Saturation</title>
          <description>Intermittent pulse oximetry to measure oxygen saturation, measured every 4 hours&#xD;
Intermittent Pulse oximeter: Pulse oximeter is a small lightweight non-invasive device placed on the fingertip or toe to measure blood oxygen saturation intermittently during hospitalization</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="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
              </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="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
              </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>
    <limitations_and_caveats>The study is limited by low patient enrollment during the study period due to the COVID-19 pandemic restrictions and low hospital admission rates for community acquired respiratory illnesses.</limitations_and_caveats>
    <point_of_contact>
      <name_or_title>Dr. Graham Krasan, Pediatric Infectious Disease Specialist</name_or_title>
      <organization>William Beaumont Hospital</organization>
      <phone>248-551-0046</phone>
      <email>graham.krasan@beaumont.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/NCT04407806
org study id: 2020-016
nct id: NCT04407806
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
is us export: No
This is a randomized, prospective study to determine if there is a difference in hospital
      length of stay between patients receiving continuous hardwire cardiorespiratory monitoring
      and those receiving intermittent vital signs measurements among pediatric patients admitted
      for uncomplicated respiratory illness.
Respiratory illnesses are among the most common causes for inpatient pediatric
      hospitalizations every year. The most common respiratory illnesses that make up these
      hospitalizations include pneumonia, acute bronchiolitis, and asthma.

      Pneumonia is one of the top three illnesses requiring pediatric hospitalization and is a
      significant cause or morbidity and mortality. The incidence of pediatric pneumonia varies
      depending on the country and age group, but worldwide the annual incidence in children
      younger than five years of age is 150 million and approximately 2 million pediatric deaths,
      per year, are attributed to pneumonia. Therefore, it is important to understand this disease
      and how it impacts pediatric hospital admissions.

      Pneumonia is defined as an acute infection of the lung parenchyma secondary to an infectious
      etiology such as viruses or bacteria. When an infectious organism is present, the defense
      mechanisms of the body, including the lungs, are disturbed and the resultant inflammation
      gives rise to parenchymal damage. Symptoms can include fever, cough, and shortness of breath.
      Findings on imaging can demonstrate infiltrates in the lungs. Vital sign testing can show
      elevations in a child's heart rate and decreases in the amount of oxygen present in the blood
      (pulse oximetry) secondary to the infiltrative processes in the lungs.

      Pneumonia is the most common serious infection in the pediatric population and accounts for
      up to 1-4% of all pediatric Emergency Department (ED) visits in the United States (US).
      Furthermore, of the pediatric patients that present to the ED with pneumonia, 20-25% are
      admitted to the inpatient pediatric unit for further management. This decision to admit a
      child to the hospital depends on various underlying factors including age, medical
      conditions, and severity of illness. One of the factors that is considered when deciding
      whether to admit a child to the hospital for pneumonia is oxygen saturation, or the amount of
      oxygen in the blood.

      Bronchiolitis is another common respiratory illness in the pediatric population and is
      estimated to account for up to 100,000 US hospital admissions annually. There is a
      seasonality with most infections occurring in the fall and winter months. It is the leading
      cause of hospitalization in infants and young children with most cases involving children
      less than two years of age.

      Acute bronchiolitis refers to lower airway inflammation and obstruction secondary to a viral
      infection. When a virus infects the terminal bronchiolar epithelial cells of the lower
      airways in the lungs, damage to these cells results and subsequently causes cellular
      sloughing and inflammation. This inflammation, coupled with mucous build-up, accounts for the
      obstruction that is seen in acute bronchiolitis. Symptoms include rhinitis, congestion,
      cough, tachypnea, wheezing, and accessory muscle use. Like pneumonia, hypoxemia (decreased
      oxygen content in the blood) can occur with acute bronchiolitis with the most severe
      complication being acute respiratory failure requiring mechanical ventilation.

      The third most common respiratory illness that accounts for pediatric hospital admissions is
      asthma. Asthma affects 1 in 12 children in the US and is a leading cause of ED visits. It is
      the most common chronic disease in childhood in developed countries and an estimated 8.3% of
      children in the US had been diagnosed with asthma in 2016.

      Asthma is a complex, multifactorial, immune-mediated disease and is defined by episodic and
      reversible airway constriction and inflammation. Triggers for asthma exacerbations can
      include infections, environmental allergens, and other irritants. Smooth muscle constriction
      in the airways and inflammation/edema result in intermittent and reversible lower airway
      obstructions. Symptoms of asthma include cough, wheezing, shortness of breath, and chest
      tightness. Like the other respiratory illnesses mentioned, asthma can also result in
      hypoxemia.

      Respiratory illnesses, including pneumonia, acute bronchiolitis, and pneumonia pose a
      significant threat to the pediatric population and are major causes of morbidity and
      mortality throughout the world. In the US, most pediatric hospital admissions are secondary
      to these illnesses and determining how to best monitor and manage these patients while in the
      hospital is important. Specifically, the most ideal technique to monitor for hypoxemia is one
      of current debate.

      Currently, there are two main ways to monitor for hypoxemia in a hospital setting. The first
      is to have a pediatric patient on continuous monitoring, which involves the child being
      continuously connected to a monitor that displays various vital signs, one of which being
      oxygen saturation (SpO2). This technique has been studied over the last several years and
      many concerns have been raised regarding alarm fatigue, or the phenomenon that occurs when a
      patient is continuously connected to a monitor and the monitor alarms an overwhelming amount.
      One study found that this form of monitoring was used in up to 50% of children in non-ICU
      settings and that up to 99% of the alarms did not require clinical action. In fact, this
      study found that more than 10,000 alarms can occur in a pediatric unit in 1 week and that
      greater than 150 alarms can occur on any one patient each day. Furthermore, while these
      continuous monitors are meant to identify patients who are deteriorating, it has been
      suggested that the efficacy is limited by alarm fatigue and that evidence has not shown them
      to improve patient outcomes. Finally, a recent study also demonstrated that the second form
      of monitoring, scheduled vital checks, may be superior to electronic measurements when
      assessing patients for deterioration. Currently, there are no guidelines to recommend what
      form of monitoring, continuous monitoring or scheduled vital checks, is superior and studies
      evaluating the rationale behind widespread continuous monitoring techniques are lacking.

      This study will determine if there is a difference in hospital length of stay between
      pediatric patients admitted for uncomplicated respiratory illnesses receiving continuous
      hardwire cardiorespiratory monitoring and those receiving intermittent vital signs
      measurements. Patients will be randomized to two groups. One group will be comprised of
      patients receiving continuous hardwire monitoring during the entire stay in the hospital. The
      other group will be comprised of patients receiving intermittent vital signs measurements
      (heart rate, respiratory rate, blood pressure, oxygen saturation, and temperature) every four
      hours, per standard of care on the pediatric unit.

      Data will be collected on supplemental oxygen use and patients' level of oxygen saturation
      throughout the hospital stay. On day of hospital discharge, up to 14 days, parents or
      guardians will be asked to complete the Parent Study Questionnaire, to assess parental rating
      of the level of care their child received in hospitalization and parental comfort level with
      continuing to care for their child at home.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Randomized, Prospective, single-site
primary purpose: Treatment
masking: None (Open Label)
measure: Length of Stay, Measured in Days
time frame: Duration of length of stay, up to 14 days
description: The start time for measurement of the length of stay will be when the order for either vitals checks or hardwire monitoring is entered in the computer. The end time for measurement of length of stay will be when the discharge order is entered into the computer system.
measure: Comfort of Parents: Level of Care Their Child Received in Hospital
time frame: On day of hospital discharge, up to 14 days
description: Parental rating of care received in hospital, as measured by "Parent Study Questionnaire",using Likert scale, where 5 represents "My child received excellent care" and 1 represents "My child received very poor care". A higher score represents a better outcome.
measure: Comfort of Parents: Continuing to Care for Their Child at Home
time frame: On day of hospital discharge, up to 14 days
description: Comfort level of parents as measured by "Parent Study Questionnaire", using Likert scale where 5 represents "very comfortable with continuing to care for child at home" and 1 represents "very uncomfortable with continuing care for child at home." A higher score represents a better outcome
measure: Frequency of Nurse Responses to Pulse Oximetry Alarms
time frame: Duration of length of stay, up to 14 days
description: Number of times nurses respond to pulse oximetry alarms, tabulated per patient
measure: Frequency of Pulse Oximetry Alarms Require Medical Intervention
time frame: Duration of length of stay, up to 14 days
description: Number of pulse oximetry alarms requiring intervention by nurses, tabulated per patient
arm group label: Continuous Pulse Oximetry Monitoring of Oxygen Saturation
arm group type: Active Comparator
description: Continuous pulse oximetry to measure oxygen saturation
arm group label: Intermittent Pulse Oximetry Monitoring of Oxygen Saturation
arm group type: Active Comparator
description: Intermittent pulse oximetry to measure oxygen saturation, measured every 4 hours
intervention type: Device
intervention name: Continous Pulse oximeter
description: Pulse oximeter is a small lightweight non-invasive device placed on the fingertip or toe to measure blood oxygen saturation throughout hospitalization
arm group label: Continuous Pulse Oximetry Monitoring of Oxygen Saturation
intervention type: Device
intervention name: Intermittent Pulse oximeter
description: Pulse oximeter is a small lightweight non-invasive device placed on the fingertip or toe to measure blood oxygen saturation intermittently during hospitalization
arm group label: Intermittent Pulse Oximetry Monitoring of Oxygen Saturation
criteria: 
gender: All
minimum age: 3 Months
maximum age: 14 Years
healthy volunteers: No
last name: Graham Krasan, MD
role: Principal Investigator
affiliation: Beaumont Health
facility: 
country: United States
citation: Ernst KD; COMMITTEE ON HOSPITAL CARE. Resources Recommended for the Care of Pediatric Patients in Hospitals. Pediatrics. 2020 Apr;145(4):e20200204. doi: 10.1542/peds.2020-0204. Epub 2020 Mar 23.
PMID: 32205465
citation: Barson, W. J., MD. (2019, September 25). Community-acquired pneumonia in children: Clinical features and diagnosis. Retrieved April 13, 2020, from https://www.uptodate.com/contents/community-acquired-pneumonia-in-children-clinical-features-and-diagnosis?search=pneumonia
citation: Jain V, Bhardwaj A. Pneumonia pathology. StatPearls. 2020.
citation: Williams DJ, Zhu Y, Grijalva CG, Self WH, Harrell FE Jr, Reed C, Stockmann C, Arnold SR, Ampofo KK, Anderson EJ, Bramley AM, Wunderink RG, McCullers JA, Pavia AT, Jain S, Edwards KM. Predicting Severe Pneumonia Outcomes in Children. Pediatrics. 2016 Oct;138(4):e20161019. doi: 10.1542/peds.2016-1019.
PMID: 27688362
citation: Gereige RS, Laufer PM. Pneumonia. Pediatr Rev. 2013 Oct;34(10):438-56; quiz 455-6. doi: 10.1542/pir.34-10-438. No abstract available. Erratum In: Pediatr Rev. 2014 Jan;35(1):29. Dosage error in article text.
PMID: 24085792
citation: Silver AH, Nazif JM. Bronchiolitis. Pediatr Rev. 2019 Nov;40(11):568-576. doi: 10.1542/pir.2018-0260. No abstract available.
PMID: 31676530
citation: Piedra, P. A., MD, & Stark, A. R., MD. (2020, March 9). Bronchiolitis in infants and children: Clinical features and diagnosis. Retrieved April 13, 2020, from https://www.uptodate.com/contents/bronchiolitis-in-infants-and-children-clinical-features-and-diagnosis?search=bronchiolitis
citation: Patel SJ, Teach SJ. Asthma. Pediatr Rev. 2019 Nov;40(11):549-567. doi: 10.1542/pir.2018-0282. No abstract available.
PMID: 31676529
citation: Sawicki, G., MD, & Haver, K., MD. (2018, November 16). Asthma in children younger than 12 years: Initial evaluation and diagnosis. Retrieved April 13, 2020, from https://www.uptodate.com/contents/asthma-in-children-younger-than-12-years-initial-evaluation-and-diagnosis?search=asthma
citation: Schondelmeyer AC, Jenkins AM, Allison B, Timmons KM, Loechtenfeldt AM, Pope-Smyth ST, Vaughn LM. Factors Influencing Use of Continuous Physiologic Monitors for Hospitalized Pediatric Patients. Hosp Pediatr. 2019 Jun;9(6):423-428. doi: 10.1542/hpeds.2019-0007. Epub 2019 May 1.
PMID: 31043435
responsible party type: Principal Investigator
investigator affiliation: William Beaumont Hospitals
investigator full name: Graham Krasan, MD
investigator title: Staff Pediatrician, Infectious Disease Specialty
mesh term: Bronchiolitis
mesh term: Respiratory Tract Diseases
mesh term: Respiration Disorders
sharing ipd: No
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
limitations and caveats: The study is limited by low patient enrollment during the study period due to the COVID-19 pandemic restrictions and low hospital admission rates for community acquired respiratory illnesses.
point of contact: 