<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/NCT04474574</url>
  </required_header>
  <id_info>
    <org_study_id>2020-01813</org_study_id>
    <nct_id>NCT04474574</nct_id>
  </id_info>
  <brief_title>How Differences in Oximeter Performance May Affect Clinical Decision</brief_title>
  <official_title>How Differences in Oximeter Performance May Affect Clinical Decision: A Pragmatic Clinical Trial in Patients Under CPAP or Noninvasive Ventilation</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Geneva</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospital, Geneva</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      In clinical practice discrepancies between overnight SpO2 recordings performed by 2 devices&#xD;
      used simultaneously are regularly observed. However, this has not been systematically studied&#xD;
      or quantified. It is therefore important to determine if these discrepancies are anecdotic,&#xD;
      or frequent, and to what extent this may affect decisions in clinical practice such as&#xD;
      implementing (or withdrawing) oxygen in subjects under noninvasive ventilation (NIV) or&#xD;
      continuous positive airway pressure (CPAP), or adjusting NIV settings.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Pulse oximetry estimates oxygen saturation in the arterial blood by trans-illuminating a&#xD;
      translucent tissue (usually a fingertip, or an ear lobe) with light-emitting diodes at 2&#xD;
      specific wavelengths. Absorption of light at these different wavelengths (660 nm, red, and&#xD;
      940 nm, infrared respectively) differs between oxygenated and deoxygenated hemoglobin. The&#xD;
      amount of light which is transmitted at both wave lengths is then quantified and processed by&#xD;
      an algorithm that displays a saturation value. The signals are corrected for the pulsatile&#xD;
      nature of arterial oxygen flow. Devices also provide pulse rate measured by plethysmography&#xD;
      (pulse-related changes in volume of fingertip or earlobe). Since its introduction in the&#xD;
      early 1980s, pulse oximetry has proven to be an essential tool for the non-invasive&#xD;
      assessment of blood oxygen saturation (SpO2). The use of pulse oximeter is now widespread and&#xD;
      interests acute care settings as well as primary care settings. Although there have been&#xD;
      recent improvements in signal analysis such as increasing sampling frequency and improving&#xD;
      reflectance technology [4], the accuracy of commercially available oximeters differs. First&#xD;
      of all, there is variability in the way accuracy of pulse oximetry devices is reported within&#xD;
      2% (± 1 SD) or within 5% (± 2 SD) of reference measurements obtained by blood gases analysis&#xD;
      [5]. Secondly, there is a variability between commercially available devices, especially&#xD;
      below a SpO2 of 90%. This is partly explained by the fact that calibration of the different&#xD;
      algorithms employed in signal processing is limited by the range of saturations that can be&#xD;
      safely obtained in healthy volunteers. In respiratory medicine, it has been shown that such&#xD;
      variability of accuracy could affect the diagnosis of Obstructive Sleep Apnea Hypopnea&#xD;
      Syndrome (OSAHS) and impact on clinical decisions as the recorded number of apneas/hypopneas&#xD;
      varied between devices during nocturnal sleep studies [8] Nocturnal hypoxemia (NH) is&#xD;
      considered as one of the major determinants of adverse cardiovascular complications and&#xD;
      neurocognitive impairment in patients suffering of chronic respiratory failure (CRF). Because&#xD;
      of its simplicity, short set-up time and short time response, pulse oximetry is a valuable&#xD;
      screening tool for nocturnal hypoxemia despite its disadvantages such as motion artefacts or&#xD;
      sensitivity to perfusion. Therefore, definitions of NH rely solely on nocturnal oximetry&#xD;
      recording: for instance, in a consensus statement on noninvasive ventilation, spending &gt; 5%&#xD;
      of sleep time under 88% of SpO2 was considered as a relevant threshold. Definitions of NH&#xD;
      remain arbitrary and different expert-based thresholds have been suggested in the medical&#xD;
      literature [10]. Patients suffering from nocturnal hypoventilation, especially those with an&#xD;
      average daytime SpO2 close to the steep portion of the hemoglobin dissociation curve (SpO2&#xD;
      between 90-94%), are at higher risk for NH. Therefore, in these patients, device imprecision&#xD;
      could have a significant impact on medical decisions, such as deciding to adjust ventilator&#xD;
      settings in patients under noninvasive ventilation (NIV) and/or implementing nocturnal oxygen&#xD;
      supplementation.&#xD;
&#xD;
      In patients with CRF and NIV, after optimal adjustment of ventilator settings, prescription&#xD;
      of nocturnal oxygen supplementation is common practice although impact of nocturnal oxygen&#xD;
      supplementation on survival, patient comfort, or prevention of cor pulmonale has yet to be&#xD;
      demonstrated. Practically speaking, it increases considerably the burden of the treatment for&#xD;
      the patient and care givers (additional connections and tubings, noise of the oxygen&#xD;
      concentrator etc.). To our knowledge, no study has evaluated how the use of different pulse&#xD;
      oximeters could impact on this decision. Three types of devices are used in clinical&#xD;
      practice: pulse oximetry using a probe connected to the home ventilator device, pulse&#xD;
      oximetry combined with transcutaneous capnography, or using a &quot;wrist watch&quot; type of device.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">August 1, 2020</start_date>
  <completion_date type="Anticipated">November 30, 2020</completion_date>
  <primary_completion_date type="Anticipated">October 31, 2020</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Degree of agreement</measure>
    <time_frame>3 months</time_frame>
    <description>The primary endpoint is the degree of agreement between 3 different devices used simultaneously for overnight SpO2 recording for 3 commonly used threshold values defining nocturnal hypoxemia: 5% of time with an SpO2 &lt; 88%, 10% of time with an SpO2 &lt; 90% or 20% of time with an SpO2 &lt; 90%.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Bland and Altman analysis of agreement</measure>
    <time_frame>3 months</time_frame>
    <description>Bland and Altman analysis of agreement between devices , two by two (A vs B, A vs C)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Degree of agreement with threshold values</measure>
    <time_frame>3 months</time_frame>
    <description>an analysis of agreement of oxygen desaturation index between devices, comparing devices 2 x 2, and using a threshold value of 10/hour as clinically significant</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Minimal SpO2 value</measure>
    <time_frame>3 months</time_frame>
    <description>a comparison of the minimal SpO2 value and time spent under different threshold levels (88 and 90%) between devices</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean pulse rate</measure>
    <time_frame>3 months</time_frame>
    <description>A comparison of average pulse rate between devices</description>
  </secondary_outcome>
  <enrollment type="Anticipated">50</enrollment>
  <condition>Sleep Apnea</condition>
  <condition>Alveolar Hypoventilation</condition>
  <condition>Nocturnal Hypoxemia</condition>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Simultaneous recording of nocturnal SpO2</intervention_name>
    <description>The intervention will consist in performing a simultaneous recording of nocturnal SpO2 and pulse rate for at least 4 hours with 3 different devices.</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Participants will be recruited among 1) hospitalized patients with NIV treatment; 2)&#xD;
        ambulatory patients followed for NIV therapy at the outpatient unit of the Division of&#xD;
        Pulmonology; 3) patients undergoing an elective polysomnography (sleep study) for&#xD;
        adjustment or titration of a positive pressure device (NIV or CPAP) at the Sleep Laboratory&#xD;
        of the Division of Pulmonology.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        -  Inclusion criteria:&#xD;
&#xD;
               -  &gt; 18 years old&#xD;
&#xD;
               -  Awake room air SpO2 between 90 and 94%&#xD;
&#xD;
               -  NIV or CPAP therapy&#xD;
&#xD;
               -  Ambulatory or hospitalized patient in a clinically stable respiratory condition&#xD;
                  without any vasopressor treatment.&#xD;
&#xD;
          -  Exclusion criteria:&#xD;
&#xD;
               -  Hospitalization in an acute care setting (e.g. emergency room, Intensive Care&#xD;
                  Unit, Intermediate Care Unit)&#xD;
&#xD;
               -  Any vasopressor treatment&#xD;
&#xD;
               -  Peripheral vascular pathologies that can affect digital perfusion (e.g. history&#xD;
                  of ischemia, Raynaud's phenomenon, any type of vasculitis).&#xD;
&#xD;
               -  Mechanical obstacles that may limit quality of signal (e.g. nail polish, bandage,&#xD;
                  splint, plaster).&#xD;
&#xD;
               -  Patient already treated by long term nocturnal oxygen therapy (LTOT)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Geneva University Hospital</name>
      <address>
        <city>Geneva</city>
        <zip>1205</zip>
        <country>Switzerland</country>
      </address>
    </facility>
    <contact>
      <last_name>Jean-Paul Janssens, Professor</last_name>
      <phone>+41223722944</phone>
      <email>jean-paul.janssens@hcuge.ch</email>
    </contact>
  </location>
  <location_countries>
    <country>Switzerland</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>July 13, 2020</study_first_submitted>
  <study_first_submitted_qc>July 13, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 17, 2020</study_first_posted>
  <last_update_submitted>July 13, 2020</last_update_submitted>
  <last_update_submitted_qc>July 13, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 17, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University Hospital, Geneva</investigator_affiliation>
    <investigator_full_name>Jean-Paul Janssens</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hypoventilation</mesh_term>
    <mesh_term>Hypoxia</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04474574
org study id: 2020-01813
nct id: NCT04474574
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
In clinical practice discrepancies between overnight SpO2 recordings performed by 2 devices
      used simultaneously are regularly observed. However, this has not been systematically studied
      or quantified. It is therefore important to determine if these discrepancies are anecdotic,
      or frequent, and to what extent this may affect decisions in clinical practice such as
      implementing (or withdrawing) oxygen in subjects under noninvasive ventilation (NIV) or
      continuous positive airway pressure (CPAP), or adjusting NIV settings.
Pulse oximetry estimates oxygen saturation in the arterial blood by trans-illuminating a
      translucent tissue (usually a fingertip, or an ear lobe) with light-emitting diodes at 2
      specific wavelengths. Absorption of light at these different wavelengths (660 nm, red, and
      940 nm, infrared respectively) differs between oxygenated and deoxygenated hemoglobin. The
      amount of light which is transmitted at both wave lengths is then quantified and processed by
      an algorithm that displays a saturation value. The signals are corrected for the pulsatile
      nature of arterial oxygen flow. Devices also provide pulse rate measured by plethysmography
      (pulse-related changes in volume of fingertip or earlobe). Since its introduction in the
      early 1980s, pulse oximetry has proven to be an essential tool for the non-invasive
      assessment of blood oxygen saturation (SpO2). The use of pulse oximeter is now widespread and
      interests acute care settings as well as primary care settings. Although there have been
      recent improvements in signal analysis such as increasing sampling frequency and improving
      reflectance technology [4], the accuracy of commercially available oximeters differs. First
      of all, there is variability in the way accuracy of pulse oximetry devices is reported within
      2% (± 1 SD) or within 5% (± 2 SD) of reference measurements obtained by blood gases analysis
      [5]. Secondly, there is a variability between commercially available devices, especially
      below a SpO2 of 90%. This is partly explained by the fact that calibration of the different
      algorithms employed in signal processing is limited by the range of saturations that can be
      safely obtained in healthy volunteers. In respiratory medicine, it has been shown that such
      variability of accuracy could affect the diagnosis of Obstructive Sleep Apnea Hypopnea
      Syndrome (OSAHS) and impact on clinical decisions as the recorded number of apneas/hypopneas
      varied between devices during nocturnal sleep studies [8] Nocturnal hypoxemia (NH) is
      considered as one of the major determinants of adverse cardiovascular complications and
      neurocognitive impairment in patients suffering of chronic respiratory failure (CRF). Because
      of its simplicity, short set-up time and short time response, pulse oximetry is a valuable
      screening tool for nocturnal hypoxemia despite its disadvantages such as motion artefacts or
      sensitivity to perfusion. Therefore, definitions of NH rely solely on nocturnal oximetry
      recording: for instance, in a consensus statement on noninvasive ventilation, spending > 5%
      of sleep time under 88% of SpO2 was considered as a relevant threshold. Definitions of NH
      remain arbitrary and different expert-based thresholds have been suggested in the medical
      literature [10]. Patients suffering from nocturnal hypoventilation, especially those with an
      average daytime SpO2 close to the steep portion of the hemoglobin dissociation curve (SpO2
      between 90-94%), are at higher risk for NH. Therefore, in these patients, device imprecision
      could have a significant impact on medical decisions, such as deciding to adjust ventilator
      settings in patients under noninvasive ventilation (NIV) and/or implementing nocturnal oxygen
      supplementation.

      In patients with CRF and NIV, after optimal adjustment of ventilator settings, prescription
      of nocturnal oxygen supplementation is common practice although impact of nocturnal oxygen
      supplementation on survival, patient comfort, or prevention of cor pulmonale has yet to be
      demonstrated. Practically speaking, it increases considerably the burden of the treatment for
      the patient and care givers (additional connections and tubings, noise of the oxygen
      concentrator etc.). To our knowledge, no study has evaluated how the use of different pulse
      oximeters could impact on this decision. Three types of devices are used in clinical
      practice: pulse oximetry using a probe connected to the home ventilator device, pulse
      oximetry combined with transcutaneous capnography, or using a "wrist watch" type of device.
observational model: Case-Only
time perspective: Prospective
measure: Degree of agreement
time frame: 3 months
description: The primary endpoint is the degree of agreement between 3 different devices used simultaneously for overnight SpO2 recording for 3 commonly used threshold values defining nocturnal hypoxemia: 5% of time with an SpO2 < 88%, 10% of time with an SpO2 < 90% or 20% of time with an SpO2 < 90%.
measure: Bland and Altman analysis of agreement
time frame: 3 months
description: Bland and Altman analysis of agreement between devices , two by two (A vs B, A vs C)
measure: Degree of agreement with threshold values
time frame: 3 months
description: an analysis of agreement of oxygen desaturation index between devices, comparing devices 2 x 2, and using a threshold value of 10/hour as clinically significant
measure: Minimal SpO2 value
time frame: 3 months
description: a comparison of the minimal SpO2 value and time spent under different threshold levels (88 and 90%) between devices
measure: Mean pulse rate
time frame: 3 months
description: A comparison of average pulse rate between devices
intervention type: Device
intervention name: Simultaneous recording of nocturnal SpO2
description: The intervention will consist in performing a simultaneous recording of nocturnal SpO2 and pulse rate for at least 4 hours with 3 different devices.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
contact: 
country: Switzerland
responsible party type: Principal Investigator
investigator affiliation: University Hospital, Geneva
investigator full name: Jean-Paul Janssens
investigator title: Professor
mesh term: Hypoventilation
mesh term: Hypoxia
sharing ipd: Undecided