<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/NCT04481308</url>
  </required_header>
  <id_info>
    <org_study_id>non-invasive co2 monitoring</org_study_id>
    <nct_id>NCT04481308</nct_id>
  </id_info>
  <brief_title>Non-invasive Carbon Dioxide Monitoring and Endoscopic Retrograde Cholangiopancreatography Patients</brief_title>
  <official_title>Reliability of Non-invasive Carbon Dioxide Monitoring During Conscious Sedation for Adult Endoscopic Retrograde Cholangiopancreatography Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Assiut University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Assiut University</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      CO2 monitoring through non-invasive methods to provide an early warning of hypoventilation&#xD;
      during procedural sedation.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Many patients become hypoxic during endoscopic retrograde cholangiopancreatography (ERCP).&#xD;
      Following induced sedation, hypoxia or hypercapnia may follow . Monitoring the CO2 level&#xD;
      during respiration (capnography) is non-invasive, easy to do, relatively inexpensive, and has&#xD;
      been studied extensively . End-tidal carbon dioxide is the level of CO2 released at the end&#xD;
      of an exhaled breath . Capnography provides information about ventilation, perfusion and&#xD;
      metabolism . Capnography devices are configured as either side stream or mainstream. Side&#xD;
      stream devices can monitor both intubated and non-intubated patients, while mainstream&#xD;
      devices are most often limited to intubated patients .&#xD;
&#xD;
      The Dual guard (made in China) sets a standard in endoscopic practices; it incorporates an&#xD;
      endoscopy bite block with oxygen delivery and CO2 monitoring for use in upper endoscopy&#xD;
      procedures through to recovery . It improves patient safety and meets current guidelines for&#xD;
      consciously sedated patients. The Comfort Rest Bite Block fits securely in the mouth,&#xD;
      protecting both endoscope and patients' teeth. Simultaneous oral and nasal O2 delivery and&#xD;
      CO2 sampling for patients undergoing upper GI endoscopy, in either a lateral or supine&#xD;
      position. Arterial blood gas test results show the patient's acid-base balance, which is&#xD;
      measured by the hydrogen ion concentration present in the blood, its oxygen saturation,&#xD;
      partial pressure of oxygen (PaO2), partial pressure of carbon dioxide (PaCO2), concentration&#xD;
      of bicarbonate (HCO3), base excess and base deficit . Itcan provide information about a&#xD;
      surgical patient's physiological state, oxygenation, ventilation and indicate the primary&#xD;
      source of a disturbance (ie, respiratory or metabolic) in homeostasis .&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Anticipated">October 2022</start_date>
  <completion_date type="Anticipated">November 2022</completion_date>
  <primary_completion_date type="Anticipated">November 2022</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Other</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>mparison between CO2 measurement from non-invasive method (Dual guard) during conscious sedation for ERCP and invasive method (arterial blood gases).</measure>
    <time_frame>october 2020</time_frame>
    <description>mparison between CO2 measurement from non-invasive method (Dual guard) during conscious sedation for ERCP and invasive method (arterial blood gases).</description>
  </primary_outcome>
  <enrollment type="Anticipated">150</enrollment>
  <condition>Patient Monitoring</condition>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>propofol (2 mg/kg) and fentanyl (1ug/kg) and 4 liters O2 flow through nasal cannula</intervention_name>
    <description>propofol (2 mg/kg) and fentanyl (1ug/kg) and 4 liters O2 flow through nasal cannula</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Adult patients aged 20-50 years.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adult patients aged 20-50 years.&#xD;
&#xD;
          -  Males or females.&#xD;
&#xD;
          -  Elective Endoscopic Retrograde Cholangiopancreatography Patients&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patient with abnormal renal function test.&#xD;
&#xD;
          -  Patient with history of chronic chest disease like asthma or Chronic obstructed&#xD;
             pulmonary diseases.&#xD;
&#xD;
          -  Patients with a history of systemic illness like hypertension and diabetes.&#xD;
&#xD;
          -  Cardiac patients.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>50 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Samar Fouad</last_name>
    <phone>01122205439</phone>
    <email>Samarfouad00@gmail.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Mohamed Abdel-Moneim Bakr</last_name>
    <phone>01223213370</phone>
    <email>bakr@aun.eu.eg</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Medicin</name>
      <address>
        <city>Assiut</city>
        <country>Egypt</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Samar</name>
      <address>
        <city>Assiut</city>
        <country>Egypt</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Mohamed Abd elmoembakr</last_name>
      <phone>01223213370</phone>
      <email>Bakr@aun.eu.eg</email>
    </contact>
    <contact_backup>
      <last_name>Ragaa Ahmed herdan</last_name>
      <phone>01001741748</phone>
      <email>ragaanesthesis@yahoo.com</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <verification_date>February 2022</verification_date>
  <study_first_submitted>July 14, 2020</study_first_submitted>
  <study_first_submitted_qc>July 17, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 22, 2020</study_first_posted>
  <last_update_submitted>February 14, 2022</last_update_submitted>
  <last_update_submitted_qc>February 14, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">February 16, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Assiut University</investigator_affiliation>
    <investigator_full_name>Samar Fouad Yones</investigator_full_name>
    <investigator_title>Resident of anesthesia and intensive care</investigator_title>
  </responsible_party>
  <keyword>Non-Invasive</keyword>
  <keyword>CO2 Monitoring</keyword>
  <keyword>Conscious Sedation</keyword>
  <keyword>Adult ERCP</keyword>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Fentanyl</mesh_term>
    <mesh_term>Propofol</mesh_term>
  </intervention_browse>
  <!-- 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/NCT04481308
org study id: non-invasive co2 monitoring
nct id: NCT04481308
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
CO2 monitoring through non-invasive methods to provide an early warning of hypoventilation
      during procedural sedation.
Many patients become hypoxic during endoscopic retrograde cholangiopancreatography (ERCP).
      Following induced sedation, hypoxia or hypercapnia may follow . Monitoring the CO2 level
      during respiration (capnography) is non-invasive, easy to do, relatively inexpensive, and has
      been studied extensively . End-tidal carbon dioxide is the level of CO2 released at the end
      of an exhaled breath . Capnography provides information about ventilation, perfusion and
      metabolism . Capnography devices are configured as either side stream or mainstream. Side
      stream devices can monitor both intubated and non-intubated patients, while mainstream
      devices are most often limited to intubated patients .

      The Dual guard (made in China) sets a standard in endoscopic practices; it incorporates an
      endoscopy bite block with oxygen delivery and CO2 monitoring for use in upper endoscopy
      procedures through to recovery . It improves patient safety and meets current guidelines for
      consciously sedated patients. The Comfort Rest Bite Block fits securely in the mouth,
      protecting both endoscope and patients' teeth. Simultaneous oral and nasal O2 delivery and
      CO2 sampling for patients undergoing upper GI endoscopy, in either a lateral or supine
      position. Arterial blood gas test results show the patient's acid-base balance, which is
      measured by the hydrogen ion concentration present in the blood, its oxygen saturation,
      partial pressure of oxygen (PaO2), partial pressure of carbon dioxide (PaCO2), concentration
      of bicarbonate (HCO3), base excess and base deficit . Itcan provide information about a
      surgical patient's physiological state, oxygenation, ventilation and indicate the primary
      source of a disturbance (ie, respiratory or metabolic) in homeostasis .
observational model: Other
time perspective: Prospective
measure: mparison between CO2 measurement from non-invasive method (Dual guard) during conscious sedation for ERCP and invasive method (arterial blood gases).
time frame: october 2020
description: mparison between CO2 measurement from non-invasive method (Dual guard) during conscious sedation for ERCP and invasive method (arterial blood gases).
intervention type: Drug
intervention name: propofol (2 mg/kg) and fentanyl (1ug/kg) and 4 liters O2 flow through nasal cannula
description: propofol (2 mg/kg) and fentanyl (1ug/kg) and 4 liters O2 flow through nasal cannula
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 20 Years
maximum age: 50 Years
healthy volunteers: No
last name: Samar Fouad
phone: 01122205439
email: Samarfouad00@gmail.com
last name: Mohamed Abdel-Moneim Bakr
phone: 01223213370
email: bakr@aun.eu.eg
facility: 
status: Recruiting
facility: 
status: Recruiting
contact: 
contact backup: 
country: Egypt
responsible party type: Principal Investigator
investigator affiliation: Assiut University
investigator full name: Samar Fouad Yones
investigator title: Resident of anesthesia and intensive care
mesh term: Fentanyl
mesh term: Propofol