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/NCT06030401</url>
    </required_header>
    <id_info>
      <org_study_id>Transthoracic US</org_study_id>
      <nct_id>NCT06030401</nct_id>
    </id_info>
    <brief_title>Role Of Transthoracic Ultrasound in Predicting Post-extubation Distress During Successful Weaning</brief_title>
    <official_title>Role Of Transthoracic Ultrasound in Predicting Post-extubation Distress During Successful Weaning</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>
        -To Assess Value of Transthoracic Ultrasound In Predicting Post-extubation Distress in&#xD;
        Respiratory ICU Using Ultrasound Parameters As Diaphragmatic Excursion&#xD;
        ,Diaphragmatic,Diaphragmatic Thickness Fraction,Diaphragmatic Thickness.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Establishing the correct time to extubate mechanically ventilated patients is a crucial issue&#xD;
        in the critical care practice. Both premature and delayed extubation prolong the duration of&#xD;
        mechanical ventilation and the intensive care unit (ICU) length of stay and increase&#xD;
        morbidity and mortality. Therefore, accurate prediction of post-extubation distress and the&#xD;
        early diagnosis of the causes responsible for failure of a trial of pressure support&#xD;
        ventilation or a trial of totally unsupported respiration are of paramount importance to&#xD;
        improve the outcome of mechanically ventilated patients in the ICU.&#xD;
  &#xD;
        The Investigators hypothesized that the use of an integrative thoracic ultrasound assessment,&#xD;
        encompassing bedside respiratory, and diaphragm sonographic data, could accurately predict&#xD;
        post-extubation distress in patients who succeeded in a pressure support ventilation trial.&#xD;
        In addition, The Investigators suggest that the use of appropriate analytical methods, that&#xD;
        is, machine-learning methods, could permit the evaluation of the specific impact of&#xD;
        respiratory and diaphragm sonographic data on the final estimation of a likelihood of&#xD;
        post-extubation distress .&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 1, 2023</start_date>
    <completion_date type="Anticipated">December 1, 2025</completion_date>
    <primary_completion_date type="Anticipated">September 1, 2025</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Cohort</observational_model>
      <time_perspective>Prospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>post-extubation distress</measure>
      <time_frame>&quot;through study completion, an average of 3 year&quot;.</time_frame>
      <description>Using Transthoracic US to measure Diaphragmatic Excursion and Diaphragmatic Thickness as Predictors of Postextubation Distress during Successful Weaning Trials.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Evaluation of different factors that affect weaning outcome as diaphragmatic dysfunction,ventilator associated pneumonia,electrolyte disturbances and so on.</measure>
      <time_frame>Doing Transthoracic US 48 hour after Starting of Mechanical Ventilation when Patient becomes Weanable during Weaning Trials,and 48 hour Postextubation Weaning and 48 hour postextubation.</time_frame>
      <description>Looking on Diaphragmatic function And If There is any Ventilator Associated pneumonia And Electrolyte Disturbance</description>
    </secondary_outcome>
    <enrollment type="Anticipated">51</enrollment>
    <condition>Transthoracic US</condition>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>Transthoracic Ultrasound</intervention_name>
      <description>Sonar of The Chest</description>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          .Any Patient Has Successful Weaning Trial above18Years old in Respiratory ICU&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Patients above 18 yrs. old who admitted to respiratory ICU and mechanically ventilated&#xD;
               due to chest diseases and passed weaning trials&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Pregnancy.&#xD;
  &#xD;
            -  Neuromuscular disorders.&#xD;
  &#xD;
            -  Psychiatric instability.&#xD;
  &#xD;
            -  Uncontrolled cardiovascular disease.&#xD;
  &#xD;
            -  Tracheostomy.&#xD;
  &#xD;
            -  patints with failed weaning trials.&#xD;
  &#xD;
            -  Inability to provide informed consent.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
    </eligibility>
    <overall_official>
      <last_name>Hoda Ahmad Ali, prof</last_name>
      <role>Study Director</role>
      <affiliation>Respiratory ICU of Assiut University Hospital</affiliation>
    </overall_official>
    <overall_official>
      <last_name>Ali Abdelazeem Hassan, prof</last_name>
      <role>Study Director</role>
      <affiliation>Respiratory ICU of Assiut University Hospital</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Rehab Haredy Hassan, Resident Physicion</last_name>
      <phone>01026128677</phone>
      <email>rehabharedy@gmail.com</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Maha kamel Ghanem, prof</last_name>
      <phone>01227694434</phone>
      <email>mahaghanem@hotmail.com</email>
    </overall_contact_backup>
    <reference>
      <citation>Frutos-Vivar F, Ferguson ND, Esteban A, Epstein SK, Arabi Y, Apezteguia C, Gonzalez M, Hill NS, Nava S, D'Empaire G, Anzueto A. Risk factors for extubation failure in patients following a successful spontaneous breathing trial. Chest. 2006 Dec;130(6):1664-71. doi: 10.1378/chest.130.6.1664.</citation>
      <PMID>17166980</PMID>
    </reference>
    <results_reference>
      <citation>Lichtenstein DA. Point-of-care ultrasound: Infection control in the intensive care unit. Crit Care Med. 2007 May;35(5 Suppl):S262-7. doi: 10.1097/01.CCM.0000260675.45549.12.</citation>
      <PMID>17446786</PMID>
    </results_reference>
    <results_reference>
      <citation>Volpicelli G, Elbarbary M, Blaivas M, Lichtenstein DA, Mathis G, Kirkpatrick AW, Melniker L, Gargani L, Noble VE, Via G, Dean A, Tsung JW, Soldati G, Copetti R, Bouhemad B, Reissig A, Agricola E, Rouby JJ, Arbelot C, Liteplo A, Sargsyan A, Silva F, Hoppmann R, Breitkreutz R, Seibel A, Neri L, Storti E, Petrovic T; International Liaison Committee on Lung Ultrasound (ILC-LUS) for International Consensus Conference on Lung Ultrasound (ICC-LUS). International evidence-based recommendations for point-of-care lung ultrasound. Intensive Care Med. 2012 Apr;38(4):577-91. doi: 10.1007/s00134-012-2513-4. Epub 2012 Mar 6.</citation>
      <PMID>22392031</PMID>
    </results_reference>
    <results_reference>
      <citation>Boussuges A, Gole Y, Blanc P. Diaphragmatic motion studied by m-mode ultrasonography: methods, reproducibility, and normal values. Chest. 2009 Feb;135(2):391-400. doi: 10.1378/chest.08-1541. Epub 2008 Nov 18.</citation>
      <PMID>19017880</PMID>
    </results_reference>
    <results_reference>
      <citation>Vivier E, Mekontso Dessap A, Dimassi S, Vargas F, Lyazidi A, Thille AW, Brochard L. Diaphragm ultrasonography to estimate the work of breathing during non-invasive ventilation. Intensive Care Med. 2012 May;38(5):796-803. doi: 10.1007/s00134-012-2547-7. Epub 2012 Apr 5.</citation>
      <PMID>22476448</PMID>
    </results_reference>
    <results_reference>
      <citation>McConville JF, Kress JP. Weaning patients from the ventilator. N Engl J Med. 2013 Mar 14;368(11):1068-9. doi: 10.1056/NEJMc1300398. No abstract available.</citation>
      <PMID>23484845</PMID>
    </results_reference>
    <results_reference>
      <citation>Epstein SK, Nevins ML, Chung J. Effect of unplanned extubation on outcome of mechanical ventilation. Am J Respir Crit Care Med. 2000 Jun;161(6):1912-6. doi: 10.1164/ajrccm.161.6.9908068.</citation>
      <PMID>10852766</PMID>
    </results_reference>
    <results_reference>
      <citation>Shen HN, Lin LY, Chen KY, Kuo PH, Yu CJ, Wu HD, Yang PC. Changes of heart rate variability during ventilator weaning. Chest. 2003 Apr;123(4):1222-8. doi: 10.1378/chest.123.4.1222.</citation>
      <PMID>12684315</PMID>
    </results_reference>
    <results_reference>
      <citation>Ueki J, De Bruin PF, Pride NB. In vivo assessment of diaphragm contraction by ultrasound in normal subjects. Thorax. 1995 Nov;50(11):1157-61. doi: 10.1136/thx.50.11.1157.</citation>
      <PMID>8553271</PMID>
    </results_reference>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>August 9, 2023</study_first_submitted>
    <study_first_submitted_qc>September 1, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 11, 2023</study_first_posted>
    <last_update_submitted>September 1, 2023</last_update_submitted>
    <last_update_submitted_qc>September 1, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 11, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Assiut University</investigator_affiliation>
      <investigator_full_name>Rehab Haredy Hassan Nafady</investigator_full_name>
      <investigator_title>Resident physicion</investigator_title>
    </responsible_party>
    <patient_data>
      <sharing_ipd>Undecided</sharing_ipd>
      <ipd_description>Follow Up of Intubated Patients During Weaning Trials Using Transthoracic US</ipd_description>
    </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/NCT06030401
  org study id: Transthoracic US
  nct id: NCT06030401
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  -To Assess Value of Transthoracic Ultrasound In Predicting Post-extubation Distress in
        Respiratory ICU Using Ultrasound Parameters As Diaphragmatic Excursion
        ,Diaphragmatic,Diaphragmatic Thickness Fraction,Diaphragmatic Thickness.
  Establishing the correct time to extubate mechanically ventilated patients is a crucial issue
        in the critical care practice. Both premature and delayed extubation prolong the duration of
        mechanical ventilation and the intensive care unit (ICU) length of stay and increase
        morbidity and mortality. Therefore, accurate prediction of post-extubation distress and the
        early diagnosis of the causes responsible for failure of a trial of pressure support
        ventilation or a trial of totally unsupported respiration are of paramount importance to
        improve the outcome of mechanically ventilated patients in the ICU.
  
        The Investigators hypothesized that the use of an integrative thoracic ultrasound assessment,
        encompassing bedside respiratory, and diaphragm sonographic data, could accurately predict
        post-extubation distress in patients who succeeded in a pressure support ventilation trial.
        In addition, The Investigators suggest that the use of appropriate analytical methods, that
        is, machine-learning methods, could permit the evaluation of the specific impact of
        respiratory and diaphragm sonographic data on the final estimation of a likelihood of
        post-extubation distress .
  observational model: Cohort
  time perspective: Prospective
  measure: post-extubation distress
  time frame: "through study completion, an average of 3 year".
  description: Using Transthoracic US to measure Diaphragmatic Excursion and Diaphragmatic Thickness as Predictors of Postextubation Distress during Successful Weaning Trials.
  measure: Evaluation of different factors that affect weaning outcome as diaphragmatic dysfunction,ventilator associated pneumonia,electrolyte disturbances and so on.
  time frame: Doing Transthoracic US 48 hour after Starting of Mechanical Ventilation when Patient becomes Weanable during Weaning Trials,and 48 hour Postextubation Weaning and 48 hour postextubation.
  description: Looking on Diaphragmatic function And If There is any Ventilator Associated pneumonia And Electrolyte Disturbance
  intervention type: Device
  intervention name: Transthoracic Ultrasound
  description: Sonar of The Chest
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  last name: Hoda Ahmad Ali, prof
  role: Study Director
  affiliation: Respiratory ICU of Assiut University Hospital
  last name: Ali Abdelazeem Hassan, prof
  role: Study Director
  affiliation: Respiratory ICU of Assiut University Hospital
  last name: Rehab Haredy Hassan, Resident Physicion
  phone: 01026128677
  email: rehabharedy@gmail.com
  last name: Maha kamel Ghanem, prof
  phone: 01227694434
  email: mahaghanem@hotmail.com
  citation: Frutos-Vivar F, Ferguson ND, Esteban A, Epstein SK, Arabi Y, Apezteguia C, Gonzalez M, Hill NS, Nava S, D'Empaire G, Anzueto A. Risk factors for extubation failure in patients following a successful spontaneous breathing trial. Chest. 2006 Dec;130(6):1664-71. doi: 10.1378/chest.130.6.1664.
  PMID: 17166980
  citation: Lichtenstein DA. Point-of-care ultrasound: Infection control in the intensive care unit. Crit Care Med. 2007 May;35(5 Suppl):S262-7. doi: 10.1097/01.CCM.0000260675.45549.12.
  PMID: 17446786
  citation: Volpicelli G, Elbarbary M, Blaivas M, Lichtenstein DA, Mathis G, Kirkpatrick AW, Melniker L, Gargani L, Noble VE, Via G, Dean A, Tsung JW, Soldati G, Copetti R, Bouhemad B, Reissig A, Agricola E, Rouby JJ, Arbelot C, Liteplo A, Sargsyan A, Silva F, Hoppmann R, Breitkreutz R, Seibel A, Neri L, Storti E, Petrovic T; International Liaison Committee on Lung Ultrasound (ILC-LUS) for International Consensus Conference on Lung Ultrasound (ICC-LUS). International evidence-based recommendations for point-of-care lung ultrasound. Intensive Care Med. 2012 Apr;38(4):577-91. doi: 10.1007/s00134-012-2513-4. Epub 2012 Mar 6.
  PMID: 22392031
  citation: Boussuges A, Gole Y, Blanc P. Diaphragmatic motion studied by m-mode ultrasonography: methods, reproducibility, and normal values. Chest. 2009 Feb;135(2):391-400. doi: 10.1378/chest.08-1541. Epub 2008 Nov 18.
  PMID: 19017880
  citation: Vivier E, Mekontso Dessap A, Dimassi S, Vargas F, Lyazidi A, Thille AW, Brochard L. Diaphragm ultrasonography to estimate the work of breathing during non-invasive ventilation. Intensive Care Med. 2012 May;38(5):796-803. doi: 10.1007/s00134-012-2547-7. Epub 2012 Apr 5.
  PMID: 22476448
  citation: McConville JF, Kress JP. Weaning patients from the ventilator. N Engl J Med. 2013 Mar 14;368(11):1068-9. doi: 10.1056/NEJMc1300398. No abstract available.
  PMID: 23484845
  citation: Epstein SK, Nevins ML, Chung J. Effect of unplanned extubation on outcome of mechanical ventilation. Am J Respir Crit Care Med. 2000 Jun;161(6):1912-6. doi: 10.1164/ajrccm.161.6.9908068.
  PMID: 10852766
  citation: Shen HN, Lin LY, Chen KY, Kuo PH, Yu CJ, Wu HD, Yang PC. Changes of heart rate variability during ventilator weaning. Chest. 2003 Apr;123(4):1222-8. doi: 10.1378/chest.123.4.1222.
  PMID: 12684315
  citation: Ueki J, De Bruin PF, Pride NB. In vivo assessment of diaphragm contraction by ultrasound in normal subjects. Thorax. 1995 Nov;50(11):1157-61. doi: 10.1136/thx.50.11.1157.
  PMID: 8553271
  responsible party type: Principal Investigator
  investigator affiliation: Assiut University
  investigator full name: Rehab Haredy Hassan Nafady
  investigator title: Resident physicion
  sharing ipd: Undecided
  ipd description: Follow Up of Intubated Patients During Weaning Trials Using Transthoracic US