<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/NCT03768232</url>
  </required_header>
  <id_info>
    <org_study_id>001</org_study_id>
    <nct_id>NCT03768232</nct_id>
  </id_info>
  <brief_title>Ventilator Induced Diaphragm Dysfunction in Pediatric Critically Ill Patients (VIDD)</brief_title>
  <acronym>VIDD</acronym>
  <official_title>Ventilator Induced Diaphragm Dysfunction in Pediatric Critically Ill Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Bambino Gesù Hospital and Research Institute</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Bambino Gesù Hospital and Research Institute</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>
      evaluation of diaphragmatic disfunction eventually occurred in pediatric patient undergoing&#xD;
      mechanical ventilation therapy&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Physician will perform US diaphragm measurements within 36 hours of initiation of MV.&#xD;
      Measurements will be repeated daily for the duration of MV for the first week, then every 48&#xD;
      hours and 24 hours after the extubation.&#xD;
&#xD;
      Exposure to and duration of continuous NMBA infusion during the course of MV and use of CS&#xD;
      will be recorded.&#xD;
&#xD;
      Ventilator logs and arterial gas analysis will be checked at the time of each US measurement&#xD;
      to ascertain ventilator settings and SBF for the 24 hours preceding each US measurement.&#xD;
&#xD;
      Extubation success will be defined as no requirement for reintubation within 48 hours&#xD;
      following extubation. The use of NIV immediately after extubation will be decided by the&#xD;
      physician in charge according to the patient clinical history (presence of withdrawal&#xD;
      syndrome, ect) and NOT according to DTF measurement.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">January 1, 2019</start_date>
  <completion_date type="Anticipated">January 1, 2020</completion_date>
  <primary_completion_date type="Anticipated">January 1, 2020</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>measurement of occurrence rate of ventilator induced diaphragm disfunction in pediatric patient</measure>
    <time_frame>through study completion an average of 100 days</time_frame>
    <description>the assessment of the actual occurrence rate of VIDD in a population of PICU patients undergoing MV for acute respiratory failure of various etiology</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>evaluation clinical impact of ventilator induced diaphragm disfunction in pediatric patient</measure>
    <time_frame>through study completion an average of 100 days</time_frame>
    <description>evaluation of the impact of VIDD and clinical outcomes of our patients in terms of Mechanical Ventilation free days</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>evaluation of two different diaphragmatic thickening fraction formula (DTF)</measure>
    <time_frame>through study completion an average of 100 days</time_frame>
    <description>evaluate the feasibility and clinical applicability of our formula for the calculation of DTF (mTdi-insp - mTdi-exp)/mTdi-med x 100, comparing it to the standard one (Tdi-insp - Tdi-exp)/Tdi-exp x 100.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>evaluation clinical impact of ventilator induced diaphragm disfunction in pediatric patient</measure>
    <time_frame>through study completion an average of 100 days</time_frame>
    <description>evaluation of the impact of VIDD and clinical outcomes of our patients, in terms of MV free days, PICU length of stay (LOS) - days</description>
  </secondary_outcome>
  <enrollment type="Anticipated">80</enrollment>
  <condition>Respiratory Failure</condition>
  <condition>Respiratory Distress Syndrome</condition>
  <condition>Mechanical Ventilation Complication</condition>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>ultrasound asessment</intervention_name>
    <description>US diaphragm measurements within 36 hours of initiation of MV. Measurements will be repeated daily for the duration of MV for the first week, then every 48 hours and 24 hours after the extubation.</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        all patient admitted in PICU&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  patients younger than 18 years old&#xD;
&#xD;
          -  expected clinical requiring of invasive MV for more than 36 hours&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  neonates&#xD;
&#xD;
          -  subjects with preexisting diagnoses of neuromuscular weakness&#xD;
&#xD;
          -  diaphragm paresis&#xD;
&#xD;
          -  chronic respiratory failure with ongoing requirement for invasive MV, or continuous&#xD;
             positive airway pressure (CPAP) or bilevel positive airway pressure (BiPAP) or with&#xD;
             likely death within 48 hours.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>28 Days</minimum_age>
    <maximum_age>18 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <results_reference>
    <citation>Demoule A, Jung B, Prodanovic H, Molinari N, Chanques G, Coirault C, Matecki S, Duguet A, Similowski T, Jaber S. Diaphragm dysfunction on admission to the intensive care unit. Prevalence, risk factors, and prognostic impact-a prospective study. Am J Respir Crit Care Med. 2013 Jul 15;188(2):213-9. doi: 10.1164/rccm.201209-1668OC.</citation>
    <PMID>23641946</PMID>
  </results_reference>
  <results_reference>
    <citation>Kim WY, Suh HJ, Hong SB, Koh Y, Lim CM. Diaphragm dysfunction assessed by ultrasonography: influence on weaning from mechanical ventilation. Crit Care Med. 2011 Dec;39(12):2627-30. doi: 10.1097/CCM.0b013e3182266408.</citation>
    <PMID>21705883</PMID>
  </results_reference>
  <results_reference>
    <citation>Levine S, Nguyen T, Taylor N, Friscia ME, Budak MT, Rothenberg P, Zhu J, Sachdeva R, Sonnad S, Kaiser LR, Rubinstein NA, Powers SK, Shrager JB. Rapid disuse atrophy of diaphragm fibers in mechanically ventilated humans. N Engl J Med. 2008 Mar 27;358(13):1327-35. doi: 10.1056/NEJMoa070447.</citation>
    <PMID>18367735</PMID>
  </results_reference>
  <results_reference>
    <citation>Francis CA, Hoffer JA, Reynolds S. Ultrasonographic Evaluation of Diaphragm Thickness During Mechanical Ventilation in Intensive Care Patients. Am J Crit Care. 2016 Jan;25(1):e1-8. doi: 10.4037/ajcc2016563.</citation>
    <PMID>26724302</PMID>
  </results_reference>
  <results_reference>
    <citation>Glau CL, Conlon TW, Himebauch AS, Yehya N, Weiss SL, Berg RA, Nishisaki A. Progressive Diaphragm Atrophy in Pediatric Acute Respiratory Failure. Pediatr Crit Care Med. 2018 May;19(5):406-411. doi: 10.1097/PCC.0000000000001485.</citation>
    <PMID>29406380</PMID>
  </results_reference>
  <results_reference>
    <citation>Goligher EC, Dres M, Fan E, Rubenfeld GD, Scales DC, Herridge MS, Vorona S, Sklar MC, Rittayamai N, Lanys A, Murray A, Brace D, Urrea C, Reid WD, Tomlinson G, Slutsky AS, Kavanagh BP, Brochard LJ, Ferguson ND. Mechanical Ventilation-induced Diaphragm Atrophy Strongly Impacts Clinical Outcomes. Am J Respir Crit Care Med. 2018 Jan 15;197(2):204-213. doi: 10.1164/rccm.201703-0536OC.</citation>
    <PMID>28930478</PMID>
  </results_reference>
  <verification_date>December 2018</verification_date>
  <study_first_submitted>November 14, 2018</study_first_submitted>
  <study_first_submitted_qc>December 5, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 7, 2018</study_first_posted>
  <last_update_submitted>December 5, 2018</last_update_submitted>
  <last_update_submitted_qc>December 5, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">December 7, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Bambino Gesù Hospital and Research Institute</investigator_affiliation>
    <investigator_full_name>Matteo Di Nardo</investigator_full_name>
    <investigator_title>Principal investigator</investigator_title>
  </responsible_party>
  <keyword>ultrasound assessment</keyword>
  <keyword>diaphragm disfuncion</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Respiratory Distress Syndrome</mesh_term>
    <mesh_term>Respiratory Distress Syndrome, Newborn</mesh_term>
    <mesh_term>Respiratory Insufficiency</mesh_term>
  </condition_browse>
  <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/NCT03768232
org study id: 001
nct id: NCT03768232
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
evaluation of diaphragmatic disfunction eventually occurred in pediatric patient undergoing
      mechanical ventilation therapy
Physician will perform US diaphragm measurements within 36 hours of initiation of MV.
      Measurements will be repeated daily for the duration of MV for the first week, then every 48
      hours and 24 hours after the extubation.

      Exposure to and duration of continuous NMBA infusion during the course of MV and use of CS
      will be recorded.

      Ventilator logs and arterial gas analysis will be checked at the time of each US measurement
      to ascertain ventilator settings and SBF for the 24 hours preceding each US measurement.

      Extubation success will be defined as no requirement for reintubation within 48 hours
      following extubation. The use of NIV immediately after extubation will be decided by the
      physician in charge according to the patient clinical history (presence of withdrawal
      syndrome, ect) and NOT according to DTF measurement.
observational model: Other
time perspective: Prospective
measure: measurement of occurrence rate of ventilator induced diaphragm disfunction in pediatric patient
time frame: through study completion an average of 100 days
description: the assessment of the actual occurrence rate of VIDD in a population of PICU patients undergoing MV for acute respiratory failure of various etiology
measure: evaluation clinical impact of ventilator induced diaphragm disfunction in pediatric patient
time frame: through study completion an average of 100 days
description: evaluation of the impact of VIDD and clinical outcomes of our patients in terms of Mechanical Ventilation free days
measure: evaluation of two different diaphragmatic thickening fraction formula (DTF)
time frame: through study completion an average of 100 days
description: evaluate the feasibility and clinical applicability of our formula for the calculation of DTF (mTdi-insp - mTdi-exp)/mTdi-med x 100, comparing it to the standard one (Tdi-insp - Tdi-exp)/Tdi-exp x 100.
measure: evaluation clinical impact of ventilator induced diaphragm disfunction in pediatric patient
time frame: through study completion an average of 100 days
description: evaluation of the impact of VIDD and clinical outcomes of our patients, in terms of MV free days, PICU length of stay (LOS) - days
intervention type: Other
intervention name: ultrasound asessment
description: US diaphragm measurements within 36 hours of initiation of MV. Measurements will be repeated daily for the duration of MV for the first week, then every 48 hours and 24 hours after the extubation.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 28 Days
maximum age: 18 Years
healthy volunteers: No
citation: Demoule A, Jung B, Prodanovic H, Molinari N, Chanques G, Coirault C, Matecki S, Duguet A, Similowski T, Jaber S. Diaphragm dysfunction on admission to the intensive care unit. Prevalence, risk factors, and prognostic impact-a prospective study. Am J Respir Crit Care Med. 2013 Jul 15;188(2):213-9. doi: 10.1164/rccm.201209-1668OC.
PMID: 23641946
citation: Kim WY, Suh HJ, Hong SB, Koh Y, Lim CM. Diaphragm dysfunction assessed by ultrasonography: influence on weaning from mechanical ventilation. Crit Care Med. 2011 Dec;39(12):2627-30. doi: 10.1097/CCM.0b013e3182266408.
PMID: 21705883
citation: Levine S, Nguyen T, Taylor N, Friscia ME, Budak MT, Rothenberg P, Zhu J, Sachdeva R, Sonnad S, Kaiser LR, Rubinstein NA, Powers SK, Shrager JB. Rapid disuse atrophy of diaphragm fibers in mechanically ventilated humans. N Engl J Med. 2008 Mar 27;358(13):1327-35. doi: 10.1056/NEJMoa070447.
PMID: 18367735
citation: Francis CA, Hoffer JA, Reynolds S. Ultrasonographic Evaluation of Diaphragm Thickness During Mechanical Ventilation in Intensive Care Patients. Am J Crit Care. 2016 Jan;25(1):e1-8. doi: 10.4037/ajcc2016563.
PMID: 26724302
citation: Glau CL, Conlon TW, Himebauch AS, Yehya N, Weiss SL, Berg RA, Nishisaki A. Progressive Diaphragm Atrophy in Pediatric Acute Respiratory Failure. Pediatr Crit Care Med. 2018 May;19(5):406-411. doi: 10.1097/PCC.0000000000001485.
PMID: 29406380
citation: Goligher EC, Dres M, Fan E, Rubenfeld GD, Scales DC, Herridge MS, Vorona S, Sklar MC, Rittayamai N, Lanys A, Murray A, Brace D, Urrea C, Reid WD, Tomlinson G, Slutsky AS, Kavanagh BP, Brochard LJ, Ferguson ND. Mechanical Ventilation-induced Diaphragm Atrophy Strongly Impacts Clinical Outcomes. Am J Respir Crit Care Med. 2018 Jan 15;197(2):204-213. doi: 10.1164/rccm.201703-0536OC.
PMID: 28930478
responsible party type: Principal Investigator
investigator affiliation: Bambino Gesù Hospital and Research Institute
investigator full name: Matteo Di Nardo
investigator title: Principal investigator
mesh term: Respiratory Distress Syndrome
mesh term: Respiratory Distress Syndrome, Newborn
mesh term: Respiratory Insufficiency
sharing ipd: No