xml: <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/NCT05972304</url>
    </required_header>
    <id_info>
      <org_study_id>EndoBreath</org_study_id>
      <nct_id>NCT05972304</nct_id>
    </id_info>
    <brief_title>Efficiency and Safety of Nasal Positive Airway Pressure Systems During Endoscopy</brief_title>
    <acronym>Endo-Breath</acronym>
    <official_title>Efficiency and Safety of Nasal Positive Airway Pressure Systems During Endoscopic Procedures in High Risk Patients. Endo-Breath-Study</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>University of Ulm</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>University of Ulm</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>
      <is_us_export>No</is_us_export>
    </oversight_info>
    <brief_summary>
      <textblock>
        Goal of our study is to investigate whether the implication of nasal positive airway pressure&#xD;
        (nPAP) system on patients with high periprocedural risk could significantly lower the&#xD;
        incidence of severe hypoxia and hypercarbia. Furthermore, we have set up goals to assess key&#xD;
        components and factors, which lead to development of hypercarbia during endoscopy.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Sedation of high-risk patients resemble a relevant issue in interventional endoscopy.&#xD;
  &#xD;
        This especially because standard oximetric monitoring displays only hypoxia and not the&#xD;
        preceding hypercapnia. Therefore, the question arises whether the implication of a nasal&#xD;
        positive airway pressure (nPAP) system can decrease the rate of sedation associated events.&#xD;
  &#xD;
        The Null Hypothesis: The incidence of hypoxia in interventional group, using nasal positive&#xD;
        airway pressure system, in comparison to control group with conventional oxygen&#xD;
        supplementation canula is not significant.&#xD;
  &#xD;
        Alternative Hypothesis: The incidence of hypoxia in interventional group, using nasal&#xD;
        positive airway pressure system is significantly lower, than in a control group with&#xD;
        conventional oxygen supplementation canula&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">April 1, 2022</start_date>
    <completion_date type="Actual">December 1, 2022</completion_date>
    <primary_completion_date type="Actual">November 1, 2022</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>
      <primary_purpose>Prevention</primary_purpose>
      <masking>Double (Participant, Care Provider)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Incidence of Hypoxia ( SpO2 &lt; 90%, lasting longer than 10 seconds) during the endoscopic procedure</measure>
      <time_frame>During endoscopic procedure</time_frame>
    </primary_outcome>
    <primary_outcome>
      <measure>Incidence of severe Hypoxia ( SpO2 &lt; 80%, lasting longer than 10 seconds) during the endoscopic procedure</measure>
      <time_frame>During endoscopic procedure</time_frame>
    </primary_outcome>
    <secondary_outcome>
      <measure>Difference of delta tcpCO2 (transcutaneous pCO2) levels between two groups</measure>
      <time_frame>During endoscopic procedure</time_frame>
      <description>Delta tcpCO2 is the difference of tpCO2 values from the beginning of the intervention to the mean tpCO2 levels observed throughout the procedure, between two groups</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Number of desaturation episodes (SpO2 &lt; 90%)</measure>
      <time_frame>During endoscopic procedure</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Interception of the intervention due to insufficient oxygenation</measure>
      <time_frame>During endoscopic procedure</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>The emmergence of serious adverse events</measure>
      <time_frame>During endoscopic procedure</time_frame>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Actual">98</enrollment>
    <condition>Hypercapnia</condition>
    <condition>Hypoxia</condition>
    <arm_group>
      <arm_group_label>Intervention Group</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Patients undergoing endoscopic procedures receiving oxygen supplementation through nasal positive airway pressure system ( 10 litters/minute).</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Control Group</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
      <description>Patients undergoing endoscopic procedures receiving conventional oxygen supplementation through nasal cannula (6 litters/minute).</description>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>Nasal positive airway System by Vyaire Medical</intervention_name>
      <description>Incidence of Hypercarbia and Hypoxia in interventional group and its monitoring using transcutaneous (SpO2) and (tCO2) Sensor</description>
      <arm_group_label>Intervention Group</arm_group_label>
      <other_name>Superno2Va</other_name>
      <other_name>Radiometer TCM 5</other_name>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  ASA III (poorly controlled Diabetes Melitus (DM) or arterial hypertension (HTN),&#xD;
               Chronic obstructive Pulmonary Disease (COPD), morbid obesity (BMI≥40), active&#xD;
               hepatitis, alcohol dependence or abuse, implanted pacemaker, moderate reduction of&#xD;
               ejection fraction, End Stage Renal Disease (ESRD), Advanced Liver Disease ( ACLD) ;&#xD;
               history (&gt;3 months) of Myocardial Infarction, coronary artery disease (CAD) ,&#xD;
               transient ischemic attack (TIA), or CAD/stents)&#xD;
  &#xD;
            -  ASA IV (recent (&lt;3 months MI, CVA, TIA, or CAD/stents, ongoing cardiac ischemia or&#xD;
               severe valve dysfunction, severe reduction of ejection fraction, sepsis, ARD or ESRD&#xD;
               not undergoing regularly scheduled dialysis&#xD;
  &#xD;
            -  Active Malignancy (ECOG Performance &gt;2)&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Patients with tracheotomy&#xD;
  &#xD;
            -  Pregnancy&#xD;
  &#xD;
            -  Intubation assisted endoscopy&#xD;
  &#xD;
            -  Procedure without sedation&#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>Universitätsklinikum Ulm</name>
        <address>
          <city>Ulm</city>
          <country>Germany</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Germany</country>
    </location_countries>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>December 29, 2022</study_first_submitted>
    <study_first_submitted_qc>August 1, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 2, 2023</study_first_posted>
    <last_update_submitted>August 1, 2023</last_update_submitted>
    <last_update_submitted_qc>August 1, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 2, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>University of Ulm</investigator_affiliation>
      <investigator_full_name>Thomas Seufferlein</investigator_full_name>
      <investigator_title>Prof. Dr. med. Benjamin Walter</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Hypoxia</mesh_term>
      <mesh_term>Hypercapnia</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05972304
  org study id: EndoBreath
  nct id: NCT05972304
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  is us export: No
  Goal of our study is to investigate whether the implication of nasal positive airway pressure
        (nPAP) system on patients with high periprocedural risk could significantly lower the
        incidence of severe hypoxia and hypercarbia. Furthermore, we have set up goals to assess key
        components and factors, which lead to development of hypercarbia during endoscopy.
  Sedation of high-risk patients resemble a relevant issue in interventional endoscopy.
  
        This especially because standard oximetric monitoring displays only hypoxia and not the
        preceding hypercapnia. Therefore, the question arises whether the implication of a nasal
        positive airway pressure (nPAP) system can decrease the rate of sedation associated events.
  
        The Null Hypothesis: The incidence of hypoxia in interventional group, using nasal positive
        airway pressure system, in comparison to control group with conventional oxygen
        supplementation canula is not significant.
  
        Alternative Hypothesis: The incidence of hypoxia in interventional group, using nasal
        positive airway pressure system is significantly lower, than in a control group with
        conventional oxygen supplementation canula
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Prevention
  masking: Double (Participant, Care Provider)
  measure: Incidence of Hypoxia ( SpO2 < 90%, lasting longer than 10 seconds) during the endoscopic procedure
  time frame: During endoscopic procedure
  measure: Incidence of severe Hypoxia ( SpO2 < 80%, lasting longer than 10 seconds) during the endoscopic procedure
  time frame: During endoscopic procedure
  measure: Difference of delta tcpCO2 (transcutaneous pCO2) levels between two groups
  time frame: During endoscopic procedure
  description: Delta tcpCO2 is the difference of tpCO2 values from the beginning of the intervention to the mean tpCO2 levels observed throughout the procedure, between two groups
  measure: Number of desaturation episodes (SpO2 < 90%)
  time frame: During endoscopic procedure
  measure: Interception of the intervention due to insufficient oxygenation
  time frame: During endoscopic procedure
  measure: The emmergence of serious adverse events
  time frame: During endoscopic procedure
  arm group label: Intervention Group
  arm group type: Experimental
  description: Patients undergoing endoscopic procedures receiving oxygen supplementation through nasal positive airway pressure system ( 10 litters/minute).
  arm group label: Control Group
  arm group type: No Intervention
  description: Patients undergoing endoscopic procedures receiving conventional oxygen supplementation through nasal cannula (6 litters/minute).
  intervention type: Device
  intervention name: Nasal positive airway System by Vyaire Medical
  description: Incidence of Hypercarbia and Hypoxia in interventional group and its monitoring using transcutaneous (SpO2) and (tCO2) Sensor
  arm group label: Intervention Group
  other name: Superno2Va
  other name: Radiometer TCM 5
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  facility: 
  country: Germany
  responsible party type: Principal Investigator
  investigator affiliation: University of Ulm
  investigator full name: Thomas Seufferlein
  investigator title: Prof. Dr. med. Benjamin Walter
  mesh term: Hypoxia
  mesh term: Hypercapnia
  sharing ipd: No