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/NCT05971264</url>
    </required_header>
    <id_info>
      <org_study_id>1002</org_study_id>
      <nct_id>NCT05971264</nct_id>
    </id_info>
    <brief_title>Comparison of Bladder Pressure Versus Regional Intestinal Tissue Oxygenation in Infants</brief_title>
    <acronym>BPvsNIRS</acronym>
    <official_title>Comparison of Bladder Pressure Versus Regional Intestinal Tissue Oxygenation in Infants</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>University Children's Hospital, Zurich</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>University Children's Hospital, Zurich</source>
    <oversight_info>
      <has_dmc>Yes</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>
        The goal of this clinical trial is to learn more about intestinal regional oxygen saturation&#xD;
        measurements made with near-infrared spectroscopy and bladder pressure measurements in&#xD;
        infants without risk of intraabdominal hypertension. The main question it aims to answer is&#xD;
        if - in comparison to bladder pressure - the regional intestinal oxygen saturation measured&#xD;
        with near-infrared spectroscopy is stable in the muscle-relaxed, intubated patients and the&#xD;
        awake and non-sedated patient.&#xD;
  &#xD;
        In case of participation the bladder pressure and the regional intestinal oxygen saturation&#xD;
        (measured with near-infrared spectroscopy) will each be measured once intraoperatively and&#xD;
        once postoperatively. Patients included in this study will be undergoing an operation which&#xD;
        necessitates muscle-relaxation, as well as an indwelling urinary catheter during the&#xD;
        operation and for a short-time thereafter for other reasons than this study.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">January 1, 2024</start_date>
    <completion_date type="Anticipated">June 30, 2026</completion_date>
    <primary_completion_date type="Anticipated">December 31, 2025</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>Intestinal rSpO2 measurements in muscle-relaxed, intubated patients</measure>
      <time_frame>intraoperative measurements taken within the first 10 minutes after anaesthesia induction</time_frame>
      <description>Our primary endpoint is the regional intestinal oxygen saturation (rSpO2) measurement (average of 5 measurements taken every 30 seconds within 2 minutes) in muscle-relaxed, intubated patients</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Intestinal rSpO2 measurements in awake, non-sedated patients</measure>
      <time_frame>postoperative measurements taken within the first three postoperative days</time_frame>
      <description>Our primary endpoint is the regional intestinal oxygen saturation (rSpO2) measurements (average of 5 measurements taken every 30 seconds within 2 minutes) in awake, non-sedated patients</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Bladder pressure values</measure>
      <time_frame>taken once intraoperatively within the first 10 minutes after anaesthesia induction and once postoperatively within the first three postoperative days</time_frame>
      <description>Bladder pressure measurements measured under two different circumstances: once muscle-relaxed, intubated patients (i.e. under ideal circumstances for these measurements) and once in awake, non-sedated patients (less ideal circumstances).</description>
    </secondary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">30</enrollment>
    <condition>Intraabdominal Hypertension</condition>
    <condition>Abdominal Compartment Syndrome</condition>
    <arm_group>
      <arm_group_label>Single Arm</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
    </arm_group>
    <intervention>
      <intervention_type>Diagnostic Test</intervention_type>
      <intervention_name>Near infrared-spectroscopy</intervention_name>
      <description>Comparison of regional intestinal oxygen saturation (measured with near infrared-spectroscopy) and indirect intraabdominal pressure measurement (bladder pressure) in muscle-relaxed, sedated patients compared to awake, non-sedated patients.</description>
      <arm_group_label>Single Arm</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Prepped and consented for laparoscopic pyeloplasty or minimal PSARP with perineal or&#xD;
               vestibular fistula or lateral thoracotomy for the correction of esophageal atresia&#xD;
  &#xD;
            -  Age of 12 months old or less at operation&#xD;
  &#xD;
            -  Legal custodian gives consent&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Anterior abdominal wall thickness greater than 12 mm measured on preoperative MRI&#xD;
               imaging if available&#xD;
  &#xD;
            -  Patients planned for additional intestinal surgeries or non-standard pyeloplasty, e.g.&#xD;
               pyeloplasty with nephrostoma&#xD;
  &#xD;
            -  Patients planned for laparoscopic pyeloplasty whose intraoperative urine sample shows&#xD;
               pathological results&#xD;
  &#xD;
            -  Patients with esophageal atresia who experience pulmonary decompensation and need&#xD;
               urgent surgery for fistula clipping&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>N/A</minimum_age>
      <maximum_age>12 Months</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Hannah R Neeser, MD</last_name>
      <role>Principal Investigator</role>
      <affiliation>University Children's Hospital of Zurich</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Hannah R Neeser, MD</last_name>
      <phone>+41442667111</phone>
      <email>hannah.neeser@kispi.uzh.ch</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Ueli Moehrlen, MD</last_name>
      <phone>+41442667111</phone>
      <email>ueli.moehrlen@kispi.uzh.ch</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>University Children's Hospital Zurich</name>
        <address>
          <city>Zürich</city>
          <state>Zurich</state>
          <zip>8032</zip>
          <country>Switzerland</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Switzerland</country>
    </location_countries>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>May 15, 2023</study_first_submitted>
    <study_first_submitted_qc>July 24, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 2, 2023</study_first_posted>
    <last_update_submitted>July 24, 2023</last_update_submitted>
    <last_update_submitted_qc>July 24, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 2, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Near infra-red spectroscopy</keyword>
    <keyword>Bladder pressure</keyword>
    <keyword>Intraabdominal pressure</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Compartment Syndromes</mesh_term>
      <mesh_term>Intra-Abdominal Hypertension</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/NCT05971264
  org study id: 1002
  nct id: NCT05971264
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  The goal of this clinical trial is to learn more about intestinal regional oxygen saturation
        measurements made with near-infrared spectroscopy and bladder pressure measurements in
        infants without risk of intraabdominal hypertension. The main question it aims to answer is
        if - in comparison to bladder pressure - the regional intestinal oxygen saturation measured
        with near-infrared spectroscopy is stable in the muscle-relaxed, intubated patients and the
        awake and non-sedated patient.
  
        In case of participation the bladder pressure and the regional intestinal oxygen saturation
        (measured with near-infrared spectroscopy) will each be measured once intraoperatively and
        once postoperatively. Patients included in this study will be undergoing an operation which
        necessitates muscle-relaxation, as well as an indwelling urinary catheter during the
        operation and for a short-time thereafter for other reasons than this study.
  allocation: N/A
  intervention model: Single Group Assignment
  primary purpose: Diagnostic
  masking: None (Open Label)
  measure: Intestinal rSpO2 measurements in muscle-relaxed, intubated patients
  time frame: intraoperative measurements taken within the first 10 minutes after anaesthesia induction
  description: Our primary endpoint is the regional intestinal oxygen saturation (rSpO2) measurement (average of 5 measurements taken every 30 seconds within 2 minutes) in muscle-relaxed, intubated patients
  measure: Intestinal rSpO2 measurements in awake, non-sedated patients
  time frame: postoperative measurements taken within the first three postoperative days
  description: Our primary endpoint is the regional intestinal oxygen saturation (rSpO2) measurements (average of 5 measurements taken every 30 seconds within 2 minutes) in awake, non-sedated patients
  measure: Bladder pressure values
  time frame: taken once intraoperatively within the first 10 minutes after anaesthesia induction and once postoperatively within the first three postoperative days
  description: Bladder pressure measurements measured under two different circumstances: once muscle-relaxed, intubated patients (i.e. under ideal circumstances for these measurements) and once in awake, non-sedated patients (less ideal circumstances).
  arm group label: Single Arm
  arm group type: Experimental
  intervention type: Diagnostic Test
  intervention name: Near infrared-spectroscopy
  description: Comparison of regional intestinal oxygen saturation (measured with near infrared-spectroscopy) and indirect intraabdominal pressure measurement (bladder pressure) in muscle-relaxed, sedated patients compared to awake, non-sedated patients.
  arm group label: Single Arm
  criteria: 
  gender: All
  minimum age: N/A
  maximum age: 12 Months
  healthy volunteers: Accepts Healthy Volunteers
  last name: Hannah R Neeser, MD
  role: Principal Investigator
  affiliation: University Children's Hospital of Zurich
  last name: Hannah R Neeser, MD
  phone: +41442667111
  email: hannah.neeser@kispi.uzh.ch
  last name: Ueli Moehrlen, MD
  phone: +41442667111
  email: ueli.moehrlen@kispi.uzh.ch
  facility: 
  country: Switzerland
  responsible party type: Sponsor
  mesh term: Compartment Syndromes
  mesh term: Intra-Abdominal Hypertension
  sharing ipd: No