<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/NCT04413318</url>
  </required_header>
  <id_info>
    <org_study_id>APHP190869</org_study_id>
    <secondary_id>IDRCB: 2019-A02246-51</secondary_id>
    <nct_id>NCT04413318</nct_id>
  </id_info>
  <brief_title>Cuff Pressure Regulation Apparatus for Tracheal Intubation in Children</brief_title>
  <acronym>CPRATIC-2</acronym>
  <official_title>A Cross-over Study to Compare Two Different Tracheal Cuff Pressure Monitoring Devices in a Pediatric Intensive Care Unit</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Assistance Publique - Hôpitaux de Paris</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Assistance Publique - Hôpitaux de Paris</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>
      Despite the expert recommendation about rigorous monitoring of tracheal cuff pressure using a&#xD;
      continuous or intermittent technique, cuff underinflation and overinflation are common&#xD;
      increasing the risk of microinhalation and tracheal ischemia. All these complications are&#xD;
      associated with high morbidity and mortality in ICU.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      In this study, the investigators will compare the duration of the period of under-inflation&#xD;
      and over-inflation between electronic (VBM©) and pneumatic (Nosten©) devices (continuous&#xD;
      monitoring of tracheal cuff pressure), in critically intubated children. This study aims to&#xD;
      determine the effectiveness of the electronic device in the continuous monitoring of tracheal&#xD;
      cuff pressure.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 12, 2020</start_date>
  <completion_date type="Actual">April 16, 2021</completion_date>
  <primary_completion_date type="Actual">April 16, 2021</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>Crossover Assignment</intervention_model>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Percentage of time spend with over or under-inflation of the tracheal cuff</measure>
    <time_frame>12 hours</time_frame>
    <description>Continuous recording of cuff pressure will be performed during the two 12-hours periods (electronic and pneumatic devices). The period was speared by a time of wash-out of 30 minutes</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>The response time to a significant variation in cuff pressure</measure>
    <time_frame>12 hours</time_frame>
    <description>Continuous recording of cuff pressure will be performed during the two 12-hours periods (electronic and pneumatic devices). Automated analysis of the response time in milliseconds to a change in cuff pressure of at least 15% above or below the target value</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">44</enrollment>
  <condition>Cuff Overinflation</condition>
  <condition>Cuff Underinflation</condition>
  <arm_group>
    <arm_group_label>electronic device followed by pneumatic device</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Children receive continuous control of tracheal cuff pressure with the electronic device (VBM©) for 6-hours followed by continuous control of tracheal cuff pressure with the pneumatic device (Nosten©) for 6-hours.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>pneumatic device followed by electronic device</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Children receive the reverse sequence (continuous control using the pneumatic device (Nosten©) for 6-hours followed by the electronic device (VBM©) for 6-hours</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Electronic device (VBM©)</intervention_name>
    <description>Continuous control of tracheal cuff pressure using an electronic device (VBM©) for 6-hours followed by continuous control using a pneumatic device (Nosten©) for 6-hours.</description>
    <arm_group_label>electronic device followed by pneumatic device</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Pneumatic device (Nosten©)</intervention_name>
    <description>Continuous control using a pneumatic device (Nosten©) for 6-hours followed by 6-hours of continuous control using an electronic device (VBM©).</description>
    <arm_group_label>pneumatic device followed by electronic device</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Infants and children more than 2 days after birth at term and less than 5 years of age&#xD;
&#xD;
          -  Patient intubated in the PICU with a cuffed endotracheal tube&#xD;
&#xD;
          -  Predicted duration of mechanical ventilation &gt; or = 24-hours&#xD;
&#xD;
          -  Signed informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Intubated with an uncuffed endotracheal tube&#xD;
&#xD;
          -  Children admitted to the PICU with a previous tracheostomy&#xD;
&#xD;
          -  Preterm children or infants less than 2 days post-term&#xD;
&#xD;
          -  Patient under block neuromuscular treatment&#xD;
&#xD;
          -  Patient enrolled in another trial that might influence this study results&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>2 Days</minimum_age>
    <maximum_age>5 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Boris LACARRA, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Assistance Publique - Hôpitaux de Paris</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Stephane DAUGER, MD PhD</last_name>
    <role>Study Director</role>
    <affiliation>Assistance Publique - Hôpitaux de Paris</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Robert Debré hospital</name>
      <address>
        <city>Paris</city>
        <zip>75019</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>May 2020</verification_date>
  <study_first_submitted>May 28, 2020</study_first_submitted>
  <study_first_submitted_qc>May 28, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 2, 2020</study_first_posted>
  <last_update_submitted>October 15, 2021</last_update_submitted>
  <last_update_submitted_qc>October 15, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">October 18, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>tracheal cuff pressure</keyword>
  <keyword>pediatric critical care</keyword>
  <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/NCT04413318
org study id: APHP190869
secondary id: IDRCB: 2019-A02246-51
nct id: NCT04413318
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Despite the expert recommendation about rigorous monitoring of tracheal cuff pressure using a
      continuous or intermittent technique, cuff underinflation and overinflation are common
      increasing the risk of microinhalation and tracheal ischemia. All these complications are
      associated with high morbidity and mortality in ICU.
In this study, the investigators will compare the duration of the period of under-inflation
      and over-inflation between electronic (VBM©) and pneumatic (Nosten©) devices (continuous
      monitoring of tracheal cuff pressure), in critically intubated children. This study aims to
      determine the effectiveness of the electronic device in the continuous monitoring of tracheal
      cuff pressure.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Supportive Care
masking: Single (Outcomes Assessor)
measure: Percentage of time spend with over or under-inflation of the tracheal cuff
time frame: 12 hours
description: Continuous recording of cuff pressure will be performed during the two 12-hours periods (electronic and pneumatic devices). The period was speared by a time of wash-out of 30 minutes
measure: The response time to a significant variation in cuff pressure
time frame: 12 hours
description: Continuous recording of cuff pressure will be performed during the two 12-hours periods (electronic and pneumatic devices). Automated analysis of the response time in milliseconds to a change in cuff pressure of at least 15% above or below the target value
arm group label: electronic device followed by pneumatic device
arm group type: Experimental
description: Children receive continuous control of tracheal cuff pressure with the electronic device (VBM©) for 6-hours followed by continuous control of tracheal cuff pressure with the pneumatic device (Nosten©) for 6-hours.
arm group label: pneumatic device followed by electronic device
arm group type: Experimental
description: Children receive the reverse sequence (continuous control using the pneumatic device (Nosten©) for 6-hours followed by the electronic device (VBM©) for 6-hours
intervention type: Device
intervention name: Electronic device (VBM©)
description: Continuous control of tracheal cuff pressure using an electronic device (VBM©) for 6-hours followed by continuous control using a pneumatic device (Nosten©) for 6-hours.
arm group label: electronic device followed by pneumatic device
intervention type: Device
intervention name: Pneumatic device (Nosten©)
description: Continuous control using a pneumatic device (Nosten©) for 6-hours followed by 6-hours of continuous control using an electronic device (VBM©).
arm group label: pneumatic device followed by electronic device
criteria: 
gender: All
minimum age: 2 Days
maximum age: 5 Years
healthy volunteers: No
last name: Boris LACARRA, MD
role: Principal Investigator
affiliation: Assistance Publique - Hôpitaux de Paris
last name: Stephane DAUGER, MD PhD
role: Study Director
affiliation: Assistance Publique - Hôpitaux de Paris
facility: 
country: France
responsible party type: Sponsor
sharing ipd: No