<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/NCT03259854</url>
  </required_header>
  <id_info>
    <org_study_id>NVM</org_study_id>
    <nct_id>NCT03259854</nct_id>
  </id_info>
  <brief_title>Non Invasive Mechanical Ventilation VERSUS Oxygen MASK</brief_title>
  <official_title>Non Invasive Mechanical Ventilation VERSUS Oxygen MASK After Successful Weaning From Invasive Mechanical Ventilation in Pediatrics</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Assiut University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Assiut University</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>
      Conventional mechanical ventilation is a core feature of intensive care. Weaning and removal&#xD;
      of endotracheal tube are crucial processes, which often account for a considerable part of&#xD;
      Conventional mechanical ventilation total time. Unsuccessful extubation has been noted to be&#xD;
      associated with an increase of both morbidity and mortality in adult and pediatric patients&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The documented rate of failed extubations ranges from 4.1 to 14% in pediatric intensive care&#xD;
      units.Therefore, strategies preventing the need for reintubation are needed.&#xD;
&#xD;
      Non invasive ventilation has been proposed as useful therapy to wean patients after&#xD;
      unsuccessful weaning trials and to avoid reintubation in adults, though controversy exists at&#xD;
      this concern.&#xD;
&#xD;
      This technique is increasingly being used in pediatric patients over the last years. The&#xD;
      objective of the present study was to determine post extubation Non invasive ventilation&#xD;
      characteristics and to identify risk factors of post extubation Non invasive ventilation&#xD;
      failure in children&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">September 1, 2017</start_date>
  <completion_date type="Anticipated">September 1, 2019</completion_date>
  <primary_completion_date type="Anticipated">September 1, 2018</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>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>risk of respiratory failure after non invasive ventilation use</measure>
    <time_frame>one week after successful weaning from invasive mechanical ventilation</time_frame>
    <description>The patients will be evaluated to determine any manifestation of respiratory failure</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>complications of non invasive mechanical ventilation in pediatrics</measure>
    <time_frame>one week after use of non invasive ventilation</time_frame>
    <description>monitor any complications from use of Non Invasive Ventilation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>length of hospital stay after non invasive ventilation use</measure>
    <time_frame>one month after use of non invasive ventilation</time_frame>
    <description>the duration of hospital stay for all patients will be recorded</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">104</enrollment>
  <condition>Mechanical Ventilation Complication</condition>
  <arm_group>
    <arm_group_label>oxygen mask control group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>patients will receive oxygen by mask will be monitored regarding oxygen saturation, blood pressure, respiratory rate, heart rate, arterial blood gases</description>
  </arm_group>
  <arm_group>
    <arm_group_label>non invasive ventilation study group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>patients will receive non invasive ventilation after successful weaning from invasive ventilation and will be monitored regarding oxygen saturation, blood pressure, respiratory rate, heart rate, arterial blood gases</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>non invasive mechanical ventilation in pediatrics</intervention_name>
    <description>use of non invasive mechanical ventilation in pediatrics after successful weaning from invasive mechanical ventilation</description>
    <arm_group_label>non invasive ventilation study group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>oxygen mask</intervention_name>
    <description>use of oxygen mask after successful weaning from invasive mechanical ventilation</description>
    <arm_group_label>oxygen mask control group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        all the patients with successful weaning from invasive mechanical ventilation&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Maxillofacial trauma&#xD;
&#xD;
          2. Gastrointestinal obstruction&#xD;
&#xD;
          3. Severe lung secretion&#xD;
&#xD;
          4. Irreversible organ failure&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>1 Month</minimum_age>
    <maximum_age>18 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Maher Mokhtar, professor</last_name>
    <phone>00201066006605</phone>
    <email>maher61ahmed@yahoo.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>mohamed amer fathy, professor</last_name>
    <phone>00201005689353</phone>
  </overall_contact_backup>
  <results_reference>
    <citation>Ferrer M, Sellares J, Valencia M, Carrillo A, Gonzalez G, Badia JR, Nicolas JM, Torres A. Non-invasive ventilation after extubation in hypercapnic patients with chronic respiratory disorders: randomised controlled trial. Lancet. 2009 Sep 26;374(9695):1082-8. doi: 10.1016/S0140-6736(09)61038-2. Epub 2009 Aug 12.</citation>
    <PMID>19682735</PMID>
  </results_reference>
  <results_reference>
    <citation>Baisch SD, Wheeler WB, Kurachek SC, Cornfield DN. Extubation failure in pediatric intensive care incidence and outcomes. Pediatr Crit Care Med. 2005 May;6(3):312-8. doi: 10.1097/01.PCC.0000161119.05076.91.</citation>
    <PMID>15857531</PMID>
  </results_reference>
  <results_reference>
    <citation>Trevisan CE, Vieira SR; Research Group in Mechanical Ventilation Weaning. Noninvasive mechanical ventilation may be useful in treating patients who fail weaning from invasive mechanical ventilation: a randomized clinical trial. Crit Care. 2008;12(2):R51. doi: 10.1186/cc6870. Epub 2008 Apr 17.</citation>
    <PMID>18416851</PMID>
  </results_reference>
  <verification_date>August 2017</verification_date>
  <study_first_submitted>August 13, 2017</study_first_submitted>
  <study_first_submitted_qc>August 21, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 24, 2017</study_first_posted>
  <last_update_submitted>August 21, 2017</last_update_submitted>
  <last_update_submitted_qc>August 21, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">August 24, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Assiut University</investigator_affiliation>
    <investigator_full_name>Mohamed Khalaf</investigator_full_name>
    <investigator_title>principal investigator</investigator_title>
  </responsible_party>
  <!-- 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/NCT03259854
org study id: NVM
nct id: NCT03259854
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Conventional mechanical ventilation is a core feature of intensive care. Weaning and removal
      of endotracheal tube are crucial processes, which often account for a considerable part of
      Conventional mechanical ventilation total time. Unsuccessful extubation has been noted to be
      associated with an increase of both morbidity and mortality in adult and pediatric patients
The documented rate of failed extubations ranges from 4.1 to 14% in pediatric intensive care
      units.Therefore, strategies preventing the need for reintubation are needed.

      Non invasive ventilation has been proposed as useful therapy to wean patients after
      unsuccessful weaning trials and to avoid reintubation in adults, though controversy exists at
      this concern.

      This technique is increasingly being used in pediatric patients over the last years. The
      objective of the present study was to determine post extubation Non invasive ventilation
      characteristics and to identify risk factors of post extubation Non invasive ventilation
      failure in children
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: risk of respiratory failure after non invasive ventilation use
time frame: one week after successful weaning from invasive mechanical ventilation
description: The patients will be evaluated to determine any manifestation of respiratory failure
measure: complications of non invasive mechanical ventilation in pediatrics
time frame: one week after use of non invasive ventilation
description: monitor any complications from use of Non Invasive Ventilation
measure: length of hospital stay after non invasive ventilation use
time frame: one month after use of non invasive ventilation
description: the duration of hospital stay for all patients will be recorded
arm group label: oxygen mask control group
arm group type: Active Comparator
description: patients will receive oxygen by mask will be monitored regarding oxygen saturation, blood pressure, respiratory rate, heart rate, arterial blood gases
arm group label: non invasive ventilation study group
arm group type: Experimental
description: patients will receive non invasive ventilation after successful weaning from invasive ventilation and will be monitored regarding oxygen saturation, blood pressure, respiratory rate, heart rate, arterial blood gases
intervention type: Device
intervention name: non invasive mechanical ventilation in pediatrics
description: use of non invasive mechanical ventilation in pediatrics after successful weaning from invasive mechanical ventilation
arm group label: non invasive ventilation study group
intervention type: Device
intervention name: oxygen mask
description: use of oxygen mask after successful weaning from invasive mechanical ventilation
arm group label: oxygen mask control group
criteria: 
gender: All
minimum age: 1 Month
maximum age: 18 Years
healthy volunteers: No
last name: Maher Mokhtar, professor
phone: 00201066006605
email: maher61ahmed@yahoo.com
last name: mohamed amer fathy, professor
phone: 00201005689353
citation: Ferrer M, Sellares J, Valencia M, Carrillo A, Gonzalez G, Badia JR, Nicolas JM, Torres A. Non-invasive ventilation after extubation in hypercapnic patients with chronic respiratory disorders: randomised controlled trial. Lancet. 2009 Sep 26;374(9695):1082-8. doi: 10.1016/S0140-6736(09)61038-2. Epub 2009 Aug 12.
PMID: 19682735
citation: Baisch SD, Wheeler WB, Kurachek SC, Cornfield DN. Extubation failure in pediatric intensive care incidence and outcomes. Pediatr Crit Care Med. 2005 May;6(3):312-8. doi: 10.1097/01.PCC.0000161119.05076.91.
PMID: 15857531
citation: Trevisan CE, Vieira SR; Research Group in Mechanical Ventilation Weaning. Noninvasive mechanical ventilation may be useful in treating patients who fail weaning from invasive mechanical ventilation: a randomized clinical trial. Crit Care. 2008;12(2):R51. doi: 10.1186/cc6870. Epub 2008 Apr 17.
PMID: 18416851
responsible party type: Principal Investigator
investigator affiliation: Assiut University
investigator full name: Mohamed Khalaf
investigator title: principal investigator