<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/NCT03268395</url>
  </required_header>
  <id_info>
    <org_study_id>2017.07.02</org_study_id>
    <nct_id>NCT03268395</nct_id>
  </id_info>
  <brief_title>Correlation of CO2 Measured by Blood Gas vs Transcutaneous Monitor</brief_title>
  <official_title>The Correlation of CO2 Measured by SenTec Transcutaneous Monitoring With Arterial Blood Gas CO2 Levels in Neonates</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Memorial Health University Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Memorial Health University Medical Center</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this clinical investigation is to compare transcutaneous CO2 (TCCO2) levels&#xD;
      measured non-invasively using the SenTec Transcutaneous CO2 Monitor to PaCO2 levels measured&#xD;
      on arterial blood gas (ABG) samples in neonatal patients being treated for respiratory&#xD;
      distress in the Neonatal Intensive Care Unit (NICU) at Memorial University Medical Center.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Background and Significance/Preliminary Studies Carbon dioxide (CO2) measurement is part of&#xD;
      the fundamental respiratory evaluation in an ICU, as both high and low values of CO2 can have&#xD;
      detrimental effects on neonatal health. The partial pressure of CO2 reflects ventilation,&#xD;
      which is the elimination of carbon dioxide. The ABG sample is the clinical tool most commonly&#xD;
      used to evaluate acid-base physiology at the bedside. It directly measures the pH, arterial&#xD;
      partial pressure of oxygen, and arterial partial pressure of CO2. Though direct measurement&#xD;
      of CO2 in the arterial blood is the most accurate way to assess the amount of CO2, it&#xD;
      requires blood sampling from the arteries and does not provide continuous monitoring of CO2.&#xD;
&#xD;
      A non-invasive tool for measuring PaCO2, such as the SenTec monitor, can help decrease blood&#xD;
      draws, thereby decreasing the incidence of iatrogenic anemia and the need for neonatal blood&#xD;
      transfusions. Blood samples are collected through arterial lines, capillary heel sticks, or&#xD;
      peripheral arterial punctures which are invasive and can be painful for the patient and may&#xD;
      potentially result in injury. Although an ABG in neonates typically only requires 0.3mL-0.5mL&#xD;
      of arterial blood, the need for frequent ABG sampling (every two to six hours) may result in&#xD;
      a significant amount of iatrogenic blood loss. A newborn has a total blood volume of only&#xD;
      80mL/kg. In addition, the transcutaneous sensor has potential monitoring advantages as&#xD;
      measurements are continuous rather than representative of a single point in time, as seen in&#xD;
      ABGs. Continuous monitoring can help to avoid fluctuations in CO2 levels which can&#xD;
      potentially result in neurologic injury in preterm babies, such as intraventricular&#xD;
      hemorrhage and periventricular leukomalacia. One of the most beneficial aspects of the SenTec&#xD;
      monitor is that it displays CO2 levels in real time, allowing clinicians to monitor trends&#xD;
      and to intervene sooner if needed.&#xD;
&#xD;
      Previous studies have been conducted on transcutaneous monitors in newborns. One such study&#xD;
      evaluated the CO-OXSYS Digital Sensor (also known as the V-Sign Digital Sensor) made by&#xD;
      SenTec. 25 patients between the ages of 10 months to 79 years of age were studied. Each&#xD;
      sensor was placed on the tragus of each patient's ear. An ABG was obtained fifteen minutes&#xD;
      after sensor application and TCCO2 measurements were recorded at the same time. ABG samples&#xD;
      were analyzed with a Rapidpoint 405 analyzer. A reliable correlation was found between the&#xD;
      TCCO2 and the PaCO2 readings (R2-0.61, p=&lt;0.001). It was noted that age and temperature did&#xD;
      not affect the accuracy of the CO2 readings. This study concluded that with more sampling,&#xD;
      the CO-OXSYS Digital Sensor would be useful in a variety of clinical settings.&#xD;
&#xD;
      A second study was performed assessing the SenTec monitor during neonatal High Frequency&#xD;
      Oscillatory Ventilation. Fourteen neonatal patients were studied. The digital sensor was&#xD;
      applied to each patient on varying body parts that included the left chest, right chest, and&#xD;
      liver. Fifteen minutes after sensor application, an ABG was obtained and the simultaneously&#xD;
      displayed TCCO2 measurement was recorded. ABG measurements were subsequently analyzed using a&#xD;
      Siemens Rapidpoint 405 analyzer. A clinically acceptable correlation was found between the&#xD;
      TCCO2 and PaCO2 readings (R2=0.807, p=&lt;0.001). This study suggested the monitor could&#xD;
      certainly be used as an alternative to ABGs.&#xD;
&#xD;
      In 2004 a study reviewed the TOSCA monitor, made by Linde Medical Sensors, which combined&#xD;
      pulse oximetry and TCCO2 monitoring. This machine used a single ear sensor which worked at 42&#xD;
      degrees C to enhance blood flow in capillaries below the sensor. This study included 60&#xD;
      neonates who had an ear sensor placed on the right earlobe. Ten minutes after placement, an&#xD;
      ABG was performed and compared to the TCCO2 reading. The transcutaneous readings were found&#xD;
      to be clinically acceptable when compared to the ABGs. A secondary benefit of the&#xD;
      transcutaneous monitoring on the earlobe was a decrease in the head movement of the neonate&#xD;
      to aid in maintaining a patent airway. In addition, the sensor did not have to be removed for&#xD;
      chest radiographs or while the parent was bonding with his or her infant in their lap (also&#xD;
      known as &quot;kangaroo care&quot;).&#xD;
&#xD;
      A recently completed study used the actual SenTec monitor I will be using. A total of 15&#xD;
      patients were included in this study with the following inclusion criteria:&#xD;
&#xD;
      Current weight &gt; =1000grams Need for mechanical ventilation Arterial access Signed informed&#xD;
      consent by parents/legal guardians The sensor was placed on the abdominal wall and when a&#xD;
      routine ABG sample was obtained, the reading from the transcutaneous device was recorded.&#xD;
      Photographs were also taken throughout the study to evaluate any injury to the skin from the&#xD;
      monitor. The photographs were randomized and a blinded reviewer rated the photographs as&#xD;
      normal, mild erythema, or burn/blistering. The reviewer of the photographs confirmed that&#xD;
      there were no adverse skin changes. It was concluded that the TCCO2 measurements obtained&#xD;
      correlated with the PaCO2 values.&#xD;
&#xD;
      Study Aims This research study is designed to assess the accuracy of SenTec transcutaneous&#xD;
      monitors for CO2 monitoring in neonatal patients. The data from this research may be used to&#xD;
      implement the SenTec monitors as part of the regular monitoring equipment used in the NICU at&#xD;
      Memorial University Medical Center. These results will contribute to my course of study by&#xD;
      aiding in my future research paper publication and poster presentation (to other ICU&#xD;
      attendings).&#xD;
&#xD;
      Administrative Organization The Level III NICU at Memorial University Medical Center will be&#xD;
      the sole participating unit. Registered nurses and/or respiratory therapists within the NICU&#xD;
      will be collecting the routine ABG samples. Respiratory therapists within the NICU will&#xD;
      analyze the ABG samples.&#xD;
&#xD;
      Study Design The design of the study will be an open-label, correlational prospective study.&#xD;
      The study population will be any neonate weighing greater than one kg at birth requiring an&#xD;
      arterial catheter for monitoring for cardiorespiratory distress. At the end of my study, if&#xD;
      it is found that the SenTec digital monitor is as accurate and valid as the ABG samples&#xD;
      collected and that no adverse skin changes are observed, I hope that the SenTec monitoring&#xD;
      system will be implemented into Memorial's regular NICU monitoring equipment. With approval&#xD;
      from the SenTec manufacturer, I will aim to write a paper and submit it to an appropriate&#xD;
      neonatal or critical care journal for future publication. In addition to the paper, I plan to&#xD;
      create a poster for presentation to critical care (PICU and NICU) unit staff (physicians,&#xD;
      RTs, RNs, and NPs) at Memorial University Medical Center.&#xD;
&#xD;
      Study Procedures The sampling plan will include any neonate with a birth weight over 1000g,&#xD;
      requiring an arterial line. Patients with significant pre-existing skin breakdown over the&#xD;
      abdominal area will be excluded from the study. Recruitment will occur exclusively in the&#xD;
      NICU. Consent will be obtained in the NICU once the arterial line has been placed. As the&#xD;
      Principal Investigator, I, and/or other Dr. Daniel Sandler will obtain consent. We will&#xD;
      provide the patient's parents with a summary of the protocol of the study and brochures&#xD;
      providing information about the sensor and its manufacturer.&#xD;
&#xD;
      There will be no placebo study agents. This is going to be a validation study. The sensor&#xD;
      will be stored in the NICU. The sensor will be placed on the patient by the patient's bedside&#xD;
      RN. Potential adverse effects should be minor and limited to mild, local skin reactions.&#xD;
&#xD;
      Serial TCCO2 measurements will be compared to PaCO2 levels measured on arterial blood gas&#xD;
      (ABG) samples obtained simultaneously on these patients. The sensor will be calibrated and&#xD;
      applied to the skin according to manufacturer instructions. Whenever an arterial blood gas is&#xD;
      collected for clinical indications, the transcutaneous monitor's reading will be&#xD;
      simultaneously recorded in a data log including the patient's initial diagnosis, gestational&#xD;
      age, sex, sensor location, birth weight, and body temperature. The skin of each infant will&#xD;
      be closely inspected for injury (such as irritation or breakdown) before the skin probe is&#xD;
      applied, and after each time that the probe is removed. Application skin sites will also be&#xD;
      photographed on entry to and exit from the study, and whenever the probe is removed.&#xD;
&#xD;
      The photographs taken and the data log will be stored in an Excel document on a Memorial&#xD;
      University Medical Center computer in the NICU. All study information will be password&#xD;
      protected. Only the investigators (Charli Cohen, Dr. Daniel Sandler), and Eric Clayton, the&#xD;
      study statistician, will have access to the study data collected.&#xD;
&#xD;
      Safety Monitoring Plan There is a slight risk for minor skin reactions from the probe. This&#xD;
      sensor has been tested in newborns and it seems that any adverse skin events have been&#xD;
      minimal. The probe has not yet been tested in extremely premature babies (weighing less than&#xD;
      one kilogram at birth). We will constantly be monitoring the patient's safety during routine&#xD;
      unit checks. The study investigators, with the assistance of NICU staff members, will&#xD;
      identify, document, and report adverse events. A patient will be removed from the study if&#xD;
      the skin reaction becomes severe. To carefully monitor for skin changes, photographs will be&#xD;
      taken before and after application of the probe.&#xD;
&#xD;
      Analysis Plan&#xD;
&#xD;
      Hypotheses:&#xD;
&#xD;
      H0: Observed mean difference between PaCO2 and TCCO2 &lt; 10 mmHg. Ha: Observed mean difference&#xD;
      between PaCO2 and TCCO2 &gt; 10 mmHg.&#xD;
&#xD;
      The study data will be analyzed using the Bland Altman technique for assessing agreement&#xD;
      between two methods of clinical measurement6. Consistency between the PaCO2 and TCCO2 methods&#xD;
      will be quantified by constructing limits of agreement (LoA). These limits are determined by&#xD;
      using the observed mean and standard deviations of the differences between the two methods. A&#xD;
      scatterplot will be constructed in which the Y-axis contains the differences in the paired&#xD;
      measurements for each case (TCCO2 - PaCO2) and the X-axis contains the means of the same&#xD;
      paired measurements ((TCCO2 + PaCO2)/2). A line representing the observed mean difference&#xD;
      will be constructed parallel to the X-axis, as will two more lines at the points ± 1.96SD of&#xD;
      the mean difference. These lines represent the LoA. 95% confidence intervals for the upper&#xD;
      and lower LoA will be calculated. The pre-defined maximum acceptable difference between the&#xD;
      methods of measurement has been determined as 10 mmHg. If the upper 95% confidence interval&#xD;
      of the upper LoA and the lower 95% confidence interval of the lower LoA are both less than 10&#xD;
      mmHg from the observed mean difference, the H_0 will be accepted and the two measurement&#xD;
      methods will be said to be in agreement.&#xD;
&#xD;
      Sample Size:&#xD;
&#xD;
      Using the published data and sample size methods, with α=0.05, β=0.20, expected mean&#xD;
      difference (D = -3.21 mmHg), expected standard deviation (SD = 3.01 mmHg), and the clinically&#xD;
      significant maximum allowed difference between the methods (δ=10 mmHg), the required minimum&#xD;
      number of paired measurements is 266.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">August 29, 2017</start_date>
  <completion_date type="Anticipated">December 30, 2018</completion_date>
  <primary_completion_date type="Anticipated">August 29, 2018</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>Observed mean CO2 difference</measure>
    <time_frame>1 Minute</time_frame>
    <description>The observed difference between arterial blood gas and transcutaneous CO2 monitor readings</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">266</enrollment>
  <condition>Respiratory Complication</condition>
  <arm_group>
    <arm_group_label>CO2 Measurement</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Each subject will received simultaneous arterial blood gas CO2 and transcutaneous CO2 monitor assessments. The correlation of these two measurements will be compared.</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Arterial Blood Gas and Transcutaneous CO2 Monitor</intervention_name>
    <description>Each patient will receive both an arterial blood gas and a transcutaneous CO2 monitor test.</description>
    <arm_group_label>CO2 Measurement</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Neonates in NICU with an arterial line&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Birth Weight &lt; 1000g&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Charli E Cohen, BS</last_name>
    <phone>6782628299</phone>
    <email>Charli.Elyse.Cohen@live.mercer.edu</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Daniel Candler, MD</last_name>
    <phone>9123508202</phone>
    <email>sandlda1@memorialhealth.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Memorial University Medical Center</name>
      <address>
        <city>Savannah</city>
        <state>Georgia</state>
        <zip>31404</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Charli E Cohen, BS</last_name>
      <phone>912-350-8202</phone>
      <email>Charli.Elyse.Cohen@live.mercer.edu</email>
    </contact>
    <contact_backup>
      <last_name>Daniel Sandler, MD</last_name>
      <phone>9123508202</phone>
    </contact_backup>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <results_reference>
    <citation>Bernet-Buettiker V, Ugarte MJ, Frey B, Hug MI, Baenziger O, Weiss M. Evaluation of a new combined transcutaneous measurement of PCO2/pulse oximetry oxygen saturation ear sensor in newborn patients. Pediatrics. 2005 Jan;115(1):e64-8. doi: 10.1542/peds.2004-0946. Epub 2004 Dec 15.</citation>
    <PMID>15601814</PMID>
  </results_reference>
  <verification_date>August 2017</verification_date>
  <study_first_submitted>August 29, 2017</study_first_submitted>
  <study_first_submitted_qc>August 30, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 31, 2017</study_first_posted>
  <last_update_submitted>August 30, 2017</last_update_submitted>
  <last_update_submitted_qc>August 30, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">August 31, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03268395
org study id: 2017.07.02
nct id: NCT03268395
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
is us export: No
The purpose of this clinical investigation is to compare transcutaneous CO2 (TCCO2) levels
      measured non-invasively using the SenTec Transcutaneous CO2 Monitor to PaCO2 levels measured
      on arterial blood gas (ABG) samples in neonatal patients being treated for respiratory
      distress in the Neonatal Intensive Care Unit (NICU) at Memorial University Medical Center.
Background and Significance/Preliminary Studies Carbon dioxide (CO2) measurement is part of
      the fundamental respiratory evaluation in an ICU, as both high and low values of CO2 can have
      detrimental effects on neonatal health. The partial pressure of CO2 reflects ventilation,
      which is the elimination of carbon dioxide. The ABG sample is the clinical tool most commonly
      used to evaluate acid-base physiology at the bedside. It directly measures the pH, arterial
      partial pressure of oxygen, and arterial partial pressure of CO2. Though direct measurement
      of CO2 in the arterial blood is the most accurate way to assess the amount of CO2, it
      requires blood sampling from the arteries and does not provide continuous monitoring of CO2.

      A non-invasive tool for measuring PaCO2, such as the SenTec monitor, can help decrease blood
      draws, thereby decreasing the incidence of iatrogenic anemia and the need for neonatal blood
      transfusions. Blood samples are collected through arterial lines, capillary heel sticks, or
      peripheral arterial punctures which are invasive and can be painful for the patient and may
      potentially result in injury. Although an ABG in neonates typically only requires 0.3mL-0.5mL
      of arterial blood, the need for frequent ABG sampling (every two to six hours) may result in
      a significant amount of iatrogenic blood loss. A newborn has a total blood volume of only
      80mL/kg. In addition, the transcutaneous sensor has potential monitoring advantages as
      measurements are continuous rather than representative of a single point in time, as seen in
      ABGs. Continuous monitoring can help to avoid fluctuations in CO2 levels which can
      potentially result in neurologic injury in preterm babies, such as intraventricular
      hemorrhage and periventricular leukomalacia. One of the most beneficial aspects of the SenTec
      monitor is that it displays CO2 levels in real time, allowing clinicians to monitor trends
      and to intervene sooner if needed.

      Previous studies have been conducted on transcutaneous monitors in newborns. One such study
      evaluated the CO-OXSYS Digital Sensor (also known as the V-Sign Digital Sensor) made by
      SenTec. 25 patients between the ages of 10 months to 79 years of age were studied. Each
      sensor was placed on the tragus of each patient's ear. An ABG was obtained fifteen minutes
      after sensor application and TCCO2 measurements were recorded at the same time. ABG samples
      were analyzed with a Rapidpoint 405 analyzer. A reliable correlation was found between the
      TCCO2 and the PaCO2 readings (R2-0.61, p=<0.001). It was noted that age and temperature did
      not affect the accuracy of the CO2 readings. This study concluded that with more sampling,
      the CO-OXSYS Digital Sensor would be useful in a variety of clinical settings.

      A second study was performed assessing the SenTec monitor during neonatal High Frequency
      Oscillatory Ventilation. Fourteen neonatal patients were studied. The digital sensor was
      applied to each patient on varying body parts that included the left chest, right chest, and
      liver. Fifteen minutes after sensor application, an ABG was obtained and the simultaneously
      displayed TCCO2 measurement was recorded. ABG measurements were subsequently analyzed using a
      Siemens Rapidpoint 405 analyzer. A clinically acceptable correlation was found between the
      TCCO2 and PaCO2 readings (R2=0.807, p=<0.001). This study suggested the monitor could
      certainly be used as an alternative to ABGs.

      In 2004 a study reviewed the TOSCA monitor, made by Linde Medical Sensors, which combined
      pulse oximetry and TCCO2 monitoring. This machine used a single ear sensor which worked at 42
      degrees C to enhance blood flow in capillaries below the sensor. This study included 60
      neonates who had an ear sensor placed on the right earlobe. Ten minutes after placement, an
      ABG was performed and compared to the TCCO2 reading. The transcutaneous readings were found
      to be clinically acceptable when compared to the ABGs. A secondary benefit of the
      transcutaneous monitoring on the earlobe was a decrease in the head movement of the neonate
      to aid in maintaining a patent airway. In addition, the sensor did not have to be removed for
      chest radiographs or while the parent was bonding with his or her infant in their lap (also
      known as "kangaroo care").

      A recently completed study used the actual SenTec monitor I will be using. A total of 15
      patients were included in this study with the following inclusion criteria:

      Current weight > =1000grams Need for mechanical ventilation Arterial access Signed informed
      consent by parents/legal guardians The sensor was placed on the abdominal wall and when a
      routine ABG sample was obtained, the reading from the transcutaneous device was recorded.
      Photographs were also taken throughout the study to evaluate any injury to the skin from the
      monitor. The photographs were randomized and a blinded reviewer rated the photographs as
      normal, mild erythema, or burn/blistering. The reviewer of the photographs confirmed that
      there were no adverse skin changes. It was concluded that the TCCO2 measurements obtained
      correlated with the PaCO2 values.

      Study Aims This research study is designed to assess the accuracy of SenTec transcutaneous
      monitors for CO2 monitoring in neonatal patients. The data from this research may be used to
      implement the SenTec monitors as part of the regular monitoring equipment used in the NICU at
      Memorial University Medical Center. These results will contribute to my course of study by
      aiding in my future research paper publication and poster presentation (to other ICU
      attendings).

      Administrative Organization The Level III NICU at Memorial University Medical Center will be
      the sole participating unit. Registered nurses and/or respiratory therapists within the NICU
      will be collecting the routine ABG samples. Respiratory therapists within the NICU will
      analyze the ABG samples.

      Study Design The design of the study will be an open-label, correlational prospective study.
      The study population will be any neonate weighing greater than one kg at birth requiring an
      arterial catheter for monitoring for cardiorespiratory distress. At the end of my study, if
      it is found that the SenTec digital monitor is as accurate and valid as the ABG samples
      collected and that no adverse skin changes are observed, I hope that the SenTec monitoring
      system will be implemented into Memorial's regular NICU monitoring equipment. With approval
      from the SenTec manufacturer, I will aim to write a paper and submit it to an appropriate
      neonatal or critical care journal for future publication. In addition to the paper, I plan to
      create a poster for presentation to critical care (PICU and NICU) unit staff (physicians,
      RTs, RNs, and NPs) at Memorial University Medical Center.

      Study Procedures The sampling plan will include any neonate with a birth weight over 1000g,
      requiring an arterial line. Patients with significant pre-existing skin breakdown over the
      abdominal area will be excluded from the study. Recruitment will occur exclusively in the
      NICU. Consent will be obtained in the NICU once the arterial line has been placed. As the
      Principal Investigator, I, and/or other Dr. Daniel Sandler will obtain consent. We will
      provide the patient's parents with a summary of the protocol of the study and brochures
      providing information about the sensor and its manufacturer.

      There will be no placebo study agents. This is going to be a validation study. The sensor
      will be stored in the NICU. The sensor will be placed on the patient by the patient's bedside
      RN. Potential adverse effects should be minor and limited to mild, local skin reactions.

      Serial TCCO2 measurements will be compared to PaCO2 levels measured on arterial blood gas
      (ABG) samples obtained simultaneously on these patients. The sensor will be calibrated and
      applied to the skin according to manufacturer instructions. Whenever an arterial blood gas is
      collected for clinical indications, the transcutaneous monitor's reading will be
      simultaneously recorded in a data log including the patient's initial diagnosis, gestational
      age, sex, sensor location, birth weight, and body temperature. The skin of each infant will
      be closely inspected for injury (such as irritation or breakdown) before the skin probe is
      applied, and after each time that the probe is removed. Application skin sites will also be
      photographed on entry to and exit from the study, and whenever the probe is removed.

      The photographs taken and the data log will be stored in an Excel document on a Memorial
      University Medical Center computer in the NICU. All study information will be password
      protected. Only the investigators (Charli Cohen, Dr. Daniel Sandler), and Eric Clayton, the
      study statistician, will have access to the study data collected.

      Safety Monitoring Plan There is a slight risk for minor skin reactions from the probe. This
      sensor has been tested in newborns and it seems that any adverse skin events have been
      minimal. The probe has not yet been tested in extremely premature babies (weighing less than
      one kilogram at birth). We will constantly be monitoring the patient's safety during routine
      unit checks. The study investigators, with the assistance of NICU staff members, will
      identify, document, and report adverse events. A patient will be removed from the study if
      the skin reaction becomes severe. To carefully monitor for skin changes, photographs will be
      taken before and after application of the probe.

      Analysis Plan

      Hypotheses:

      H0: Observed mean difference between PaCO2 and TCCO2 < 10 mmHg. Ha: Observed mean difference
      between PaCO2 and TCCO2 > 10 mmHg.

      The study data will be analyzed using the Bland Altman technique for assessing agreement
      between two methods of clinical measurement6. Consistency between the PaCO2 and TCCO2 methods
      will be quantified by constructing limits of agreement (LoA). These limits are determined by
      using the observed mean and standard deviations of the differences between the two methods. A
      scatterplot will be constructed in which the Y-axis contains the differences in the paired
      measurements for each case (TCCO2 - PaCO2) and the X-axis contains the means of the same
      paired measurements ((TCCO2 + PaCO2)/2). A line representing the observed mean difference
      will be constructed parallel to the X-axis, as will two more lines at the points ± 1.96SD of
      the mean difference. These lines represent the LoA. 95% confidence intervals for the upper
      and lower LoA will be calculated. The pre-defined maximum acceptable difference between the
      methods of measurement has been determined as 10 mmHg. If the upper 95% confidence interval
      of the upper LoA and the lower 95% confidence interval of the lower LoA are both less than 10
      mmHg from the observed mean difference, the H_0 will be accepted and the two measurement
      methods will be said to be in agreement.

      Sample Size:

      Using the published data and sample size methods, with α=0.05, β=0.20, expected mean
      difference (D = -3.21 mmHg), expected standard deviation (SD = 3.01 mmHg), and the clinically
      significant maximum allowed difference between the methods (δ=10 mmHg), the required minimum
      number of paired measurements is 266.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: Observed mean CO2 difference
time frame: 1 Minute
description: The observed difference between arterial blood gas and transcutaneous CO2 monitor readings
arm group label: CO2 Measurement
arm group type: Other
description: Each subject will received simultaneous arterial blood gas CO2 and transcutaneous CO2 monitor assessments. The correlation of these two measurements will be compared.
intervention type: Diagnostic Test
intervention name: Arterial Blood Gas and Transcutaneous CO2 Monitor
description: Each patient will receive both an arterial blood gas and a transcutaneous CO2 monitor test.
arm group label: CO2 Measurement
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Charli E Cohen, BS
phone: 6782628299
email: Charli.Elyse.Cohen@live.mercer.edu
last name: Daniel Candler, MD
phone: 9123508202
email: sandlda1@memorialhealth.com
facility: 
status: Recruiting
contact: 
contact backup: 
country: United States
citation: Bernet-Buettiker V, Ugarte MJ, Frey B, Hug MI, Baenziger O, Weiss M. Evaluation of a new combined transcutaneous measurement of PCO2/pulse oximetry oxygen saturation ear sensor in newborn patients. Pediatrics. 2005 Jan;115(1):e64-8. doi: 10.1542/peds.2004-0946. Epub 2004 Dec 15.
PMID: 15601814
responsible party type: Sponsor
sharing ipd: No