<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/NCT02983851</url>
  </required_header>
  <id_info>
    <org_study_id>VENIM</org_study_id>
    <nct_id>NCT02983851</nct_id>
  </id_info>
  <brief_title>Initial Ventilation Strategy for Adult Immunocompromised Patients With Acute Respiratory Failure</brief_title>
  <official_title>Initial Ventilation Strategy for Adult Immunocompromised Patients With Acute Respiratory Failure</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Peking Union Medical College Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Natural Science Foundation of China</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Ministry of Health, China</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Fujian Provincial Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>First Affiliated Hospital of Kunming Medical University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>First Affiliated Hospital, Sun Yat-Sen University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Renmin Hospital of Wuhan University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>The First Affiliated Hospital of Zhengzhou University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>The First Affiliated Hospital with Nanjing Medical University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>The Second Hospital of Hebei Medical University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>The First Affiliated Hospital of Anhui Medical University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>The Affiliated Hospital Of Guizhou Medical University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>The Affiliated Hospital of Inner Mongolia Medical University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>General Hospital of Ningxia Medical University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Tianjin Medical University General Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Second Xiangya Hospital of Central South University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>The Second Affiliated Hospital of Harbin Medical University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Cangzhou Central Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Handan First Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Peking Union Medical College Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      VENIM is a multicenter, open-label, parallel-group randomized controlled trial of studying&#xD;
      the initial ventilation strategy for adult immunocompromised patients with acute respiratory&#xD;
      failure.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The VENIM is a multicenter randomized controlled trial (RCT) comparing the effects of NIV&#xD;
      compared with IMV in adult immunocompromised patients with moderate to severe acute&#xD;
      respiratory failure (ARF). Patients who meet the indications for both ventilatory supports&#xD;
      will be included. The intervention will consist of randomly allocation, treatment with NIV or&#xD;
      IMV, concomitant medication. Primary outcome is 30-day hospital mortality. Secondary outcomes&#xD;
      include in-hospital mortality, length of stay in hospital, improvement of oxygenation,&#xD;
      nosocomial infections, seven-day organ failure, adverse events of intervention, et al.&#xD;
      Subgroups with different disease severity, causes of immunodeficiency and types of ARF will&#xD;
      also be analyzed.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date>December 2016</start_date>
  <completion_date type="Anticipated">December 2018</completion_date>
  <primary_completion_date type="Anticipated">September 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>Treatment</primary_purpose>
    <masking>Double (Participant, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>30-day all-cause mortality</measure>
    <time_frame>the 30th day after patient inclusion in the study</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>In-hospital mortality</measure>
    <time_frame>through study study completion, an average of 2 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Length of stay in hospital</measure>
    <time_frame>through study study completion, an average of 2 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Length of mechanical ventilation</measure>
    <time_frame>through study study completion, an average of 2 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Nosocomial infections</measure>
    <time_frame>through study study completion, an average of 2 years</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">238</enrollment>
  <condition>Immunocompromised Patients</condition>
  <condition>Acute Respiratory Failure</condition>
  <arm_group>
    <arm_group_label>Noninvasive mechanical ventilation</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients in this group will receive Noninvasive mechanical ventilation as the initial mechanical ventilation (MV) strategy, irrespective of whether Invasive mechanical ventilation is used later during the following treatment.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Invasive mechanical ventilation</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patients in this group will receive Invasive mechanical ventilation as the initial MV strategy, irrespective of whether Noninvasive mechanical ventilation is used later during the following treatment.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Noninvasive mechanical ventilation</intervention_name>
    <description>Noninvasive mechanical ventilation will be delivered to the patient through a mask. The mask will be adjusted and connected to a ventilation system.</description>
    <arm_group_label>Noninvasive mechanical ventilation</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Invasive mechanical ventilation</intervention_name>
    <description>Invasive mechanical ventilation will be initially performed by using the volume controlled mode, and could be adjusted to pressure controlled mode or other modes based on clinical situation.</description>
    <arm_group_label>Invasive mechanical ventilation</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adult (18 years old ≤ age ≤ 80 years old) immunocompromised patients admitted to&#xD;
             hospital with moderate to severe ARF diagnosed within the last 72 hours, which meets&#xD;
             the indications for ventilatory support.&#xD;
&#xD;
          -  Patients are considered as moderate to severe ARF when the ratio of the partial&#xD;
             pressure of arterial oxygen to the fraction of inspired oxygen (PaO2/FiO2) is between&#xD;
             85 and 170 while the patient is breathing oxygen through a Venturi mask, or clinically&#xD;
             diagnosed as the following:&#xD;
&#xD;
               1. 30 mmHg &lt; PaO2 &lt; 50 mmHg on room air;&#xD;
&#xD;
               2. Clinical evidence of respiratory distress (intercostal recession, polypnea&#xD;
                  &gt;35/min or dyspnea at rest).&#xD;
&#xD;
          -  Patients are considered as immunocompromised when clinically diagnosed as at least one&#xD;
             of the following:&#xD;
&#xD;
               1. HIV infection;&#xD;
&#xD;
               2. Hematologic malignancy or solid tumor under chemotherapy;&#xD;
&#xD;
               3. Solid organ or stem cell transplant;&#xD;
&#xD;
               4. Long-term (&gt;30 days) or high dose steroids (&gt;1 mg/kg/d prednisone equivalent)&#xD;
                  usage and/or any other immunosuppressive drugs;&#xD;
&#xD;
               5. Neutropenia (defined as a neutrocyte count of &lt; 0.50×109/L) showing for at least&#xD;
                  48 hours&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Age&lt;18 or &gt;80 years old;&#xD;
&#xD;
          -  Partial pressure of arterial carbon dioxide (PaCO2) &gt; 50 mmHg or arterial pH &lt; 7.20;&#xD;
&#xD;
          -  PaO2/FiO2 &gt;170 or PaO2/FiO2&lt; 85;&#xD;
&#xD;
          -  Patients have been treated with NIV or IMV within 30 days.&#xD;
&#xD;
          -  NIV is contraindicated or IMV is definitely indicated, including PaO2/FiO2&lt; 85,&#xD;
             respiratory arrest, hemodynamic instability, inability to fit the face mask,&#xD;
             pneumothorax, vomiting, development of airway bleeding, inability to protect the&#xD;
             airway, or copious respiratory secretions;&#xD;
&#xD;
          -  Comorbided with other severe diseases, including New York Heart Association functional&#xD;
             class ≥ II, valvular heart disease, dilated cardiomyopathy, cardiogenic pulmonary&#xD;
             edema, implanted cardiac pacemaker, unstable angina, myocardial infarction, or cardiac&#xD;
             surgery within the previous 3 months; systolic arterial pressure &lt;90 mmHg after&#xD;
             optimal fluid therapy; history of chronic obstructive pulmonary disease (COPD) or&#xD;
             asthma; impaired consciousness (Glasgow Coma Scale score &lt;13); postoperative acute&#xD;
             respiratory failure; pregnancy or breastfeeding;&#xD;
&#xD;
          -  Lack of consent, do-not-intubate decision, and any other situations where obvious bias&#xD;
             are expected&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Yi Li, M.D.</last_name>
    <role>Study Chair</role>
    <affiliation>PUMC hospital,Chinese Academy of Medical Sciences</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Yi Li, M.D.</last_name>
    <phone>13693109826</phone>
    <email>billliyi@126.com</email>
  </overall_contact>
  <verification_date>December 2016</verification_date>
  <study_first_submitted>November 25, 2016</study_first_submitted>
  <study_first_submitted_qc>December 2, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 6, 2016</study_first_posted>
  <last_update_submitted>December 2, 2016</last_update_submitted>
  <last_update_submitted_qc>December 2, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 6, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Peking Union Medical College Hospital</investigator_affiliation>
    <investigator_full_name>Yi Li, MD</investigator_full_name>
    <investigator_title>Chief physician of Emergency Department, professor</investigator_title>
  </responsible_party>
  <keyword>Noninvasive mechanical ventilation</keyword>
  <keyword>Invasive mechanical ventilation</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Respiratory Insufficiency</mesh_term>
    <mesh_term>Respiratory Distress Syndrome</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT02983851
org study id: VENIM
nct id: NCT02983851
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: Yes
VENIM is a multicenter, open-label, parallel-group randomized controlled trial of studying
      the initial ventilation strategy for adult immunocompromised patients with acute respiratory
      failure.
The VENIM is a multicenter randomized controlled trial (RCT) comparing the effects of NIV
      compared with IMV in adult immunocompromised patients with moderate to severe acute
      respiratory failure (ARF). Patients who meet the indications for both ventilatory supports
      will be included. The intervention will consist of randomly allocation, treatment with NIV or
      IMV, concomitant medication. Primary outcome is 30-day hospital mortality. Secondary outcomes
      include in-hospital mortality, length of stay in hospital, improvement of oxygenation,
      nosocomial infections, seven-day organ failure, adverse events of intervention, et al.
      Subgroups with different disease severity, causes of immunodeficiency and types of ARF will
      also be analyzed.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Outcomes Assessor)
measure: 30-day all-cause mortality
time frame: the 30th day after patient inclusion in the study
measure: In-hospital mortality
time frame: through study study completion, an average of 2 years
measure: Length of stay in hospital
time frame: through study study completion, an average of 2 years
measure: Length of mechanical ventilation
time frame: through study study completion, an average of 2 years
measure: Nosocomial infections
time frame: through study study completion, an average of 2 years
arm group label: Noninvasive mechanical ventilation
arm group type: Experimental
description: Patients in this group will receive Noninvasive mechanical ventilation as the initial mechanical ventilation (MV) strategy, irrespective of whether Invasive mechanical ventilation is used later during the following treatment.
arm group label: Invasive mechanical ventilation
arm group type: Active Comparator
description: Patients in this group will receive Invasive mechanical ventilation as the initial MV strategy, irrespective of whether Noninvasive mechanical ventilation is used later during the following treatment.
intervention type: Procedure
intervention name: Noninvasive mechanical ventilation
description: Noninvasive mechanical ventilation will be delivered to the patient through a mask. The mask will be adjusted and connected to a ventilation system.
arm group label: Noninvasive mechanical ventilation
intervention type: Procedure
intervention name: Invasive mechanical ventilation
description: Invasive mechanical ventilation will be initially performed by using the volume controlled mode, and could be adjusted to pressure controlled mode or other modes based on clinical situation.
arm group label: Invasive mechanical ventilation
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
last name: Yi Li, M.D.
role: Study Chair
affiliation: PUMC hospital,Chinese Academy of Medical Sciences
last name: Yi Li, M.D.
phone: 13693109826
email: billliyi@126.com
responsible party type: Principal Investigator
investigator affiliation: Peking Union Medical College Hospital
investigator full name: Yi Li, MD
investigator title: Chief physician of Emergency Department, professor
mesh term: Respiratory Insufficiency
mesh term: Respiratory Distress Syndrome
sharing ipd: Undecided