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/NCT06029699</url>
    </required_header>
    <id_info>
      <org_study_id>HFNC vs NIPPV</org_study_id>
      <nct_id>NCT06029699</nct_id>
    </id_info>
    <brief_title>High Flow Nasal Cannula Versus Non Invasive Positive Pressure Ventilation in Reducing The Rate of Reintubation</brief_title>
    <official_title>High Flow Nasal Cannula Versus Non Invasive Positive Pressure Ventilation in Reducing Reintubation in Mechanically Ventilated Patient</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>
        This is study aim to compare between high flow nasal canula (HFNC) and non invasive positive&#xD;
        pressure ventilation (NIPPV) in reducing the rate of reintubation in mechanically ventilated&#xD;
        patient with successful weaning&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        -  High-flow nasal cannula (HFNC) oxygen therapy comprises an air/oxygen blender, an active&#xD;
             humidifier, a single heated circuit, and a nasal cannula. It delivers adequately heated&#xD;
             and humidified medical gas at up to 60 L/min of flow and is considered to have a number&#xD;
             of physiological effects: reduction of anatomical dead space, positive end expiratory&#xD;
             pressure ( PEEP ) effect, constant fraction of inspired oxygen, and good humidification&#xD;
  &#xD;
          -  Noninvasive positive-pressure ventilation is a safe and effective means of improving gas&#xD;
             exchange in patients with many types of acute respiratory failure . for example, adding&#xD;
             noninvasive ventilation to standard therapy decreased the need for endotracheal&#xD;
             intubation...For patients assigned to noninvasive ventilation, the ventilator was&#xD;
             connected with conventional tubing to a clear, full-face mask with an inflatable&#xD;
             soft-cushion seal and a disposable foam spacer to reduce dead space .After the mask had&#xD;
             been secured, pressure support was increased to achieve an exhaled tidal volume of 8 to&#xD;
             10 ml per kilogram, a respiratory rate of fewer than 25 breaths per minute, the&#xD;
             disappearance of accessory muscle activity (as evaluated by palpation of the&#xD;
             sternocleidomastoid muscle), and patient comfort&#xD;
  &#xD;
          -  The effects of high-flow nasal cannula (HFNC) on adult patients with acute respiratory&#xD;
             failure (ARF) are controversial. The investigators aimed to further determine the&#xD;
             effectiveness of HFNC in reducing the rate of endotracheal intubation in adult patients&#xD;
             with ARF by comparison to noninvasive positive pressure ventilation (NIPPV)&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">October 1, 2023</start_date>
    <completion_date type="Anticipated">October 1, 2026</completion_date>
    <primary_completion_date type="Anticipated">October 1, 2024</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>
      <intervention_model_description>When the patient become weanable from mechanical ventilation, the subjects were extubated immediately and randomly divided into two groups, with one group receiving HFNC (called HFNC group), the other group receiving NIPPV (called NIPPV group)</intervention_model_description>
      <primary_purpose>Treatment</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>the need for re-intubation and weaning success which will be measured by arterial blood gas ( ABG )</measure>
      <time_frame>baseline</time_frame>
    </primary_outcome>
    <secondary_outcome>
      <measure>Duration of using of HFNC or NIPPV</measure>
      <time_frame>up to 30 days</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Length of hospital stay measured by days</measure>
      <time_frame>up to 30 days</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>In - hospital mortality measured by number of died cases</measure>
      <time_frame>up to 30 days</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Adverse events</measure>
      <time_frame>up to 30 days</time_frame>
      <description>Adverse events (occurrence of nosocomial pneumonia based on clinical and laboratory and radiological finding, need for MV measured by re-intubation rate)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Incidence of any possible complications associated with the use of HFNC and NIPPV</measure>
      <time_frame>up to 30 days</time_frame>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">50</enrollment>
    <condition>Respiratory Failure</condition>
    <condition>Re-intubation Rate</condition>
    <arm_group>
      <arm_group_label>high flow nasal cannula group</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>patients put on high flow nasal cannula after extubation</description>
    </arm_group>
    <arm_group>
      <arm_group_label>non invasive positive pressure ventilation group</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>patients put on non invasive positive pressure ventilation group after extubation</description>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>high flow nasal cannula</intervention_name>
      <description>device are used for weaning patients after mechanical ventilation extubation</description>
      <arm_group_label>high flow nasal cannula group</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>non invasive positive pressure ventilation</intervention_name>
      <description>device are used for weaning patients after mechanical ventilation extubation</description>
      <arm_group_label>non invasive positive pressure ventilation group</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  All patient suffer from acute respiratory failure and intubated for mechanical&#xD;
               ventilation and then extubated for weaning&#xD;
  &#xD;
            -  Age &gt;18 years old&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  In patients less than 18 years old&#xD;
  &#xD;
            -  Any contradiction in using HFNC as trauma or surgery or obstruction of nasopharynx&#xD;
  &#xD;
            -  Any contradiction in using NIPPV as facial trauma ..surgery ..deformity..or upper&#xD;
               airway obstruction or upper gastrointestinal bleeding or high risk of aspiration&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>100 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>mohamed osman shehata abdelkareem, resident doctor</last_name>
      <phone>+201123368743</phone>
      <email>abkmod@gmail.com</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Maha Kamel Ghanem, professor</last_name>
      <phone>+201227694434</phone>
      <email>mahaghanem@hotmail.com</email>
    </overall_contact_backup>
    <reference>
      <citation>Nishimura M. High-flow nasal cannula oxygen therapy in adults. J Intensive Care. 2015 Mar 31;3(1):15. doi: 10.1186/s40560-015-0084-5. eCollection 2015.</citation>
      <PMID>25866645</PMID>
    </reference>
    <reference>
      <citation>Meyer TJ, Hill NS. Noninvasive positive pressure ventilation to treat respiratory failure. Ann Intern Med. 1994 May 1;120(9):760-70. doi: 10.7326/0003-4819-120-9-199405010-00008.</citation>
      <PMID>8147550</PMID>
    </reference>
    <reference>
      <citation>Ni YN, Luo J, Yu H, Liu D, Ni Z, Cheng J, Liang BM, Liang ZA. Can High-flow Nasal Cannula Reduce the Rate of Endotracheal Intubation in Adult Patients With Acute Respiratory Failure Compared With Conventional Oxygen Therapy and Noninvasive Positive Pressure Ventilation?: A Systematic Review and Meta-analysis. Chest. 2017 Apr;151(4):764-775. doi: 10.1016/j.chest.2017.01.004. Epub 2017 Jan 13.</citation>
      <PMID>28089816</PMID>
    </reference>
    <reference>
      <citation>Fang G, Wan Q, Tian Y, Jia W, Luo X, Yang T, Shi Y, Gu X, Xu S. [Comparative study on pros and cons of sequential high-flow nasal cannula and non-invasive positive pressure ventilation immediately following early extubated patients with severe respiratory failure due to acute exacerbations of chronic obstructive pulmonary disease]. Zhonghua Wei Zhong Bing Ji Jiu Yi Xue. 2021 Oct;33(10):1215-1220. doi: 10.3760/cma.j.cn121430-20210623-00939. Chinese.</citation>
      <PMID>34955131</PMID>
    </reference>
    <reference>
      <citation>Gomez-Merino E, Sancho J, Marin J, Servera E, Blasco ML, Belda FJ, Castro C, Bach JR. Mechanical insufflation-exsufflation: pressure, volume, and flow relationships and the adequacy of the manufacturer's guidelines. Am J Phys Med Rehabil. 2002 Aug;81(8):579-83. doi: 10.1097/00002060-200208000-00004.</citation>
      <PMID>12172066</PMID>
    </reference>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>August 25, 2023</study_first_submitted>
    <study_first_submitted_qc>September 7, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 8, 2023</study_first_posted>
    <last_update_submitted>September 7, 2023</last_update_submitted>
    <last_update_submitted_qc>September 7, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 8, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Assiut University</investigator_affiliation>
      <investigator_full_name>Mohamed Osman Shehata Abdelkareem</investigator_full_name>
      <investigator_title>resident doctor</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Respiratory Insufficiency</mesh_term>
    </condition_browse>
    <!-- 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/NCT06029699
  org study id: HFNC vs NIPPV
  nct id: NCT06029699
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  This is study aim to compare between high flow nasal canula (HFNC) and non invasive positive
        pressure ventilation (NIPPV) in reducing the rate of reintubation in mechanically ventilated
        patient with successful weaning
  -  High-flow nasal cannula (HFNC) oxygen therapy comprises an air/oxygen blender, an active
             humidifier, a single heated circuit, and a nasal cannula. It delivers adequately heated
             and humidified medical gas at up to 60 L/min of flow and is considered to have a number
             of physiological effects: reduction of anatomical dead space, positive end expiratory
             pressure ( PEEP ) effect, constant fraction of inspired oxygen, and good humidification
  
          -  Noninvasive positive-pressure ventilation is a safe and effective means of improving gas
             exchange in patients with many types of acute respiratory failure . for example, adding
             noninvasive ventilation to standard therapy decreased the need for endotracheal
             intubation...For patients assigned to noninvasive ventilation, the ventilator was
             connected with conventional tubing to a clear, full-face mask with an inflatable
             soft-cushion seal and a disposable foam spacer to reduce dead space .After the mask had
             been secured, pressure support was increased to achieve an exhaled tidal volume of 8 to
             10 ml per kilogram, a respiratory rate of fewer than 25 breaths per minute, the
             disappearance of accessory muscle activity (as evaluated by palpation of the
             sternocleidomastoid muscle), and patient comfort
  
          -  The effects of high-flow nasal cannula (HFNC) on adult patients with acute respiratory
             failure (ARF) are controversial. The investigators aimed to further determine the
             effectiveness of HFNC in reducing the rate of endotracheal intubation in adult patients
             with ARF by comparison to noninvasive positive pressure ventilation (NIPPV)
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: When the patient become weanable from mechanical ventilation, the subjects were extubated immediately and randomly divided into two groups, with one group receiving HFNC (called HFNC group), the other group receiving NIPPV (called NIPPV group)
  primary purpose: Treatment
  masking: None (Open Label)
  measure: the need for re-intubation and weaning success which will be measured by arterial blood gas ( ABG )
  time frame: baseline
  measure: Duration of using of HFNC or NIPPV
  time frame: up to 30 days
  measure: Length of hospital stay measured by days
  time frame: up to 30 days
  measure: In - hospital mortality measured by number of died cases
  time frame: up to 30 days
  measure: Adverse events
  time frame: up to 30 days
  description: Adverse events (occurrence of nosocomial pneumonia based on clinical and laboratory and radiological finding, need for MV measured by re-intubation rate)
  measure: Incidence of any possible complications associated with the use of HFNC and NIPPV
  time frame: up to 30 days
  arm group label: high flow nasal cannula group
  arm group type: Active Comparator
  description: patients put on high flow nasal cannula after extubation
  arm group label: non invasive positive pressure ventilation group
  arm group type: Active Comparator
  description: patients put on non invasive positive pressure ventilation group after extubation
  intervention type: Device
  intervention name: high flow nasal cannula
  description: device are used for weaning patients after mechanical ventilation extubation
  arm group label: high flow nasal cannula group
  intervention type: Device
  intervention name: non invasive positive pressure ventilation
  description: device are used for weaning patients after mechanical ventilation extubation
  arm group label: non invasive positive pressure ventilation group
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 100 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: mohamed osman shehata abdelkareem, resident doctor
  phone: +201123368743
  email: abkmod@gmail.com
  last name: Maha Kamel Ghanem, professor
  phone: +201227694434
  email: mahaghanem@hotmail.com
  citation: Nishimura M. High-flow nasal cannula oxygen therapy in adults. J Intensive Care. 2015 Mar 31;3(1):15. doi: 10.1186/s40560-015-0084-5. eCollection 2015.
  PMID: 25866645
  citation: Meyer TJ, Hill NS. Noninvasive positive pressure ventilation to treat respiratory failure. Ann Intern Med. 1994 May 1;120(9):760-70. doi: 10.7326/0003-4819-120-9-199405010-00008.
  PMID: 8147550
  citation: Ni YN, Luo J, Yu H, Liu D, Ni Z, Cheng J, Liang BM, Liang ZA. Can High-flow Nasal Cannula Reduce the Rate of Endotracheal Intubation in Adult Patients With Acute Respiratory Failure Compared With Conventional Oxygen Therapy and Noninvasive Positive Pressure Ventilation?: A Systematic Review and Meta-analysis. Chest. 2017 Apr;151(4):764-775. doi: 10.1016/j.chest.2017.01.004. Epub 2017 Jan 13.
  PMID: 28089816
  citation: Fang G, Wan Q, Tian Y, Jia W, Luo X, Yang T, Shi Y, Gu X, Xu S. [Comparative study on pros and cons of sequential high-flow nasal cannula and non-invasive positive pressure ventilation immediately following early extubated patients with severe respiratory failure due to acute exacerbations of chronic obstructive pulmonary disease]. Zhonghua Wei Zhong Bing Ji Jiu Yi Xue. 2021 Oct;33(10):1215-1220. doi: 10.3760/cma.j.cn121430-20210623-00939. Chinese.
  PMID: 34955131
  citation: Gomez-Merino E, Sancho J, Marin J, Servera E, Blasco ML, Belda FJ, Castro C, Bach JR. Mechanical insufflation-exsufflation: pressure, volume, and flow relationships and the adequacy of the manufacturer's guidelines. Am J Phys Med Rehabil. 2002 Aug;81(8):579-83. doi: 10.1097/00002060-200208000-00004.
  PMID: 12172066
  responsible party type: Principal Investigator
  investigator affiliation: Assiut University
  investigator full name: Mohamed Osman Shehata Abdelkareem
  investigator title: resident doctor
  mesh term: Respiratory Insufficiency