<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/NCT03278795</url>
  </required_header>
  <id_info>
    <org_study_id>VSVVPSVAAWMOMVCOPDP</org_study_id>
    <nct_id>NCT03278795</nct_id>
  </id_info>
  <brief_title>VSV Versus PSV as a Weaning Mode of Mechanically Ventilated Chronic Obstructive Pulmonary Disease Patients</brief_title>
  <official_title>Volume Support Ventilation Versus Pressure Support Ventilation as a Weaning Mode of Mechanically Ventilated Chronic Obstructive Pulmonary Disease Patients</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>
      Chronic Obstructive Pulmonary Disease (COPD) is a common, preventable and treatable disease&#xD;
      that is characterized by persistent respiratory symptoms and airflow limitation that is due&#xD;
      to airway and/or alveolar abnormalities usually caused by significant exposure to noxious&#xD;
      particles or gases. Acute exacerbations may occur during the management of stable COPD which&#xD;
      can negatively impact health status, rates of hospitalization and re-admission. During&#xD;
      exacerbation, some patients need immediate admission to the respiratory intensive care unit&#xD;
      (RICU) for ventilatory support. As prolonged mechanical ventilation has unfavourable impacts,&#xD;
      it is Important to minimize the duration of mechanical ventilation and perform extubation as&#xD;
      soon as possible. In recent years, development of numerous models of artificial respiration,&#xD;
      which could support spontaneous breathing, has made it possible to gradually decrease the&#xD;
      mechanical ventilatory support. From these new modes, PSV which is a well known weaning mode&#xD;
      will be compared in our study to a new weaning mode which is a volume support ventilation&#xD;
      (VSV).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Acute exacerbations may occur during the management of stable COPD which can negatively&#xD;
      impact health status, rates of hospitalization and re-admission. During exacerbation, some&#xD;
      patients need immediate admission to the respiratory intensive care unit (RICU). Ventilatory&#xD;
      support in an exacerbation can be provided by either noninvasive (nasal or facial mask) or&#xD;
      invasive (oro-tracheal tube or tracheostomy) ventilation.&#xD;
&#xD;
      Mechanical ventilation may be complicated by barotrauma, volutrauma, and also unfavourable&#xD;
      impacts on cardiovascular system and organ perfusion. Moreover, prolonged mechanical&#xD;
      ventilation enhances the risk of nosocomial pneumonia. So it is Important to minimize the&#xD;
      duration of mechanical ventilation and perform extubation as soon as possible. In recent&#xD;
      years, development of numerous models of artificial respiration, which could support&#xD;
      spontaneous breathing, has made it possible to gradually decrease the mechanical ventilatory&#xD;
      support.&#xD;
&#xD;
      From these new modes, PSV (pressure-support ventilation) which is a well known weaning mode&#xD;
      will be compared in our study to a new weaning mode which is a volume support ventilation&#xD;
      (VSV).&#xD;
&#xD;
      VSV could be viewed as &quot;PRVC for spontaneous breathing&quot; as it delivers a variable pressure to&#xD;
      meet a target VT.&#xD;
&#xD;
        -  The ventilator gives a test breath with an inspiratory pressure of 10 cmH2O above PEEP&#xD;
           (5 cmH2O in earlier software versions)&#xD;
&#xD;
        -  It measures the volume delivered and calculates system Compliance&#xD;
&#xD;
        -  For each subsequent breath, the ventilator calculates compliance of the previous breath&#xD;
           and adjusts the inspiratory pressure level (pressure level) to achieve the set VT on the&#xD;
           next breath&#xD;
&#xD;
        -  The ventilator will not change the inspiratory pressure by more than 3 cm H2O from one&#xD;
           breath to the next&#xD;
&#xD;
        -  Maximum available inspiratory pressure level is 5 cm H2O below the preset upper pressure&#xD;
           limit (alarm will sound at this point and the breath will switch into exhalation)&#xD;
&#xD;
        -  The minimum pressure limit is the baseline setting (PEEP)&#xD;
&#xD;
        -  If apnea occurs, back up pressure control is activated and an alarm sounds&#xD;
&#xD;
        -  If Auto mode is on and patient becomes apneic, the mode will automatically switch to&#xD;
           PRVC(pressure regulated volume control).&#xD;
&#xD;
      In PSV patients in whom a 8 cm H2O pressure support level could be achieved,a 2-h trial of&#xD;
      spontaneous breathing with this pressure support level will performed before extubation .&#xD;
&#xD;
      In the VSV group, VT(tidal volume) will be adjusted at 6 ml/ Kg and If the patients showed&#xD;
      good tolerance with an acceptable ABG (arterial blood gas)analysis (pH o7.35, PaO2(partial&#xD;
      pressure of arterial oxygen)/FIO2 .150 with an FIO2(fraction of inspired oxygen) f 40%, RR&#xD;
      (respiratory rate) f 35 breaths/min), they will ventilated for 2-h trial of spontaneous&#xD;
      breathing and then extubated&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">September 2017</start_date>
  <completion_date type="Anticipated">March 2020</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>
    <intervention_model_description>The study group will be assigned to SIMV-VC for at least 48 hours . Patients will be assessed daily for fulfillment of criteria of readiness to wean according to European Respiratory Society guidelines (ERS guidelines ).&#xD;
After fulfillment of ERS weaning criteria patients will be consequently divided into two equal groups: 1. 25 patients will be assigned to PSV weaning mode.&#xD;
2. 25 patients will be assigned to VSV weaning mode. In PSV weaning group , PS will be adjusted 8 cm H2O. In VSV weaning group ,VT will be adjusted 6 ml/ Kg. Extubation will be done after successful spontaneous breathing trial according to ERS guidelines .</intervention_model_description>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Success rate</measure>
    <time_frame>the first 48 hours after ex-tubation from mechanical ventilation .</time_frame>
    <description>Assess success rate of PSV and VSV in weaning of COPD patients .Weaning success is defined as extubation and the absence of ventilatory support 48h following the extubation .</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Detection of response to both modes</measure>
    <time_frame>the first 48 hours after ex-tubation from mechanical ventilation .</time_frame>
    <description>if there was a decrease in the total weaning time ,assisted ventilation time and total time of mechanical ventilation .</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of weaning trials</measure>
    <time_frame>the first 48 hours after ex-tubation from mechanical ventilation .</time_frame>
    <description>Detection of number of spontaneous breathing trials needed for weaning among both modes</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">50</enrollment>
  <condition>COPD</condition>
  <arm_group>
    <arm_group_label>PSV mode</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>PSV weaning group</description>
  </arm_group>
  <arm_group>
    <arm_group_label>VSV mode</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>VSV weaning group</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>pressure support ventilation mode</intervention_name>
    <description>PSV is the sole mode of mechanical ventilation and will be used as a weaning mode in mechanically ventilated chronic obstructive pulmonary disease patients,In PSV weaning group , PS(pressure support) will be adjusted at 8 cmH2O until 2-h successful spontaneous breathing trial parameters according to ERS(European Respiratory Society) guidelines will be achieved and then patient will ex-tubated.</description>
    <arm_group_label>PSV mode</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>volume support ventilation mode</intervention_name>
    <description>VSV mode could be viewed as &quot;PRVC for spontaneous breathing&quot; as it delivers a variable pressure to meet a target VT. VSV will be used as a weaning mode in mechanically ventilated chronic obstructive pulmonary disease patients,In VSV weaning group ,VT(tidal volume ) will be adjusted at 6 ml/ Kg until 2-h successful spontaneous breathing trial parameters according to ERS guidelines will be achieved and then patient will ex-tubated.</description>
    <arm_group_label>VSV mode</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  All mechanically ventilated COPD patients at RICU.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  COPD patients associated bronchiectasis , interstitial lung disease and pneumonia.&#xD;
&#xD;
          -  Neurological and neuromuscular diseases hindering the respiratory drive.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Maha Ghanem, Prof</last_name>
    <phone>00201227694434</phone>
    <email>mahaghanem@hotmail.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Hoda Makhlouf, Prof</last_name>
    <phone>00201001529442</phone>
    <email>hamakhlouf@yahoo.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Assiut University Hospital</name>
      <address>
        <city>Assiut</city>
        <zip>Assiut University71515</zip>
        <country>Egypt</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <reference>
    <citation>Barnes PJ, Celli BR. Systemic manifestations and comorbidities of COPD. Eur Respir J. 2009 May;33(5):1165-85. doi: 10.1183/09031936.00128008.</citation>
    <PMID>19407051</PMID>
  </reference>
  <reference>
    <citation>Sancar NK, Ozcan PE, Senturk E, Selek C, Cakar N. The Comparison of Pressure (PSV) and Volume Support Ventilation (VSV) as a 'Weaning' Mode. Turk J Anaesthesiol Reanim. 2014 Aug;42(4):170-5. doi: 10.5152/TJAR.2014.61687. Epub 2014 May 29.</citation>
    <PMID>27366416</PMID>
  </reference>
  <reference>
    <citation>Ruiz-Santana S, Garcia Jimenez A, Esteban A, Guerra L, Alvarez B, Corcia S, Gudin J, Martinez A, Quintana E, Armengol S, et al. ICU pneumonias: a multi-institutional study. Crit Care Med. 1987 Oct;15(10):930-2. doi: 10.1097/00003246-198710000-00007.</citation>
    <PMID>3652708</PMID>
  </reference>
  <reference>
    <citation>Boles JM, Bion J, Connors A, Herridge M, Marsh B, Melot C, Pearl R, Silverman H, Stanchina M, Vieillard-Baron A, Welte T. Weaning from mechanical ventilation. Eur Respir J. 2007 May;29(5):1033-56. doi: 10.1183/09031936.00010206.</citation>
    <PMID>17470624</PMID>
  </reference>
  <verification_date>September 2017</verification_date>
  <study_first_submitted>August 25, 2017</study_first_submitted>
  <study_first_submitted_qc>September 8, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 12, 2017</study_first_posted>
  <last_update_submitted>September 12, 2017</last_update_submitted>
  <last_update_submitted_qc>September 12, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">September 13, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Assiut University</investigator_affiliation>
    <investigator_full_name>Alaa Mohammed Taghyan</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>Weaning, ventilatory support, assisted ventilation modes</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lung Diseases, Obstructive</mesh_term>
    <mesh_term>Pulmonary Disease, Chronic Obstructive</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/NCT03278795
org study id: VSVVPSVAAWMOMVCOPDP
nct id: NCT03278795
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Chronic Obstructive Pulmonary Disease (COPD) is a common, preventable and treatable disease
      that is characterized by persistent respiratory symptoms and airflow limitation that is due
      to airway and/or alveolar abnormalities usually caused by significant exposure to noxious
      particles or gases. Acute exacerbations may occur during the management of stable COPD which
      can negatively impact health status, rates of hospitalization and re-admission. During
      exacerbation, some patients need immediate admission to the respiratory intensive care unit
      (RICU) for ventilatory support. As prolonged mechanical ventilation has unfavourable impacts,
      it is Important to minimize the duration of mechanical ventilation and perform extubation as
      soon as possible. In recent years, development of numerous models of artificial respiration,
      which could support spontaneous breathing, has made it possible to gradually decrease the
      mechanical ventilatory support. From these new modes, PSV which is a well known weaning mode
      will be compared in our study to a new weaning mode which is a volume support ventilation
      (VSV).
Acute exacerbations may occur during the management of stable COPD which can negatively
      impact health status, rates of hospitalization and re-admission. During exacerbation, some
      patients need immediate admission to the respiratory intensive care unit (RICU). Ventilatory
      support in an exacerbation can be provided by either noninvasive (nasal or facial mask) or
      invasive (oro-tracheal tube or tracheostomy) ventilation.

      Mechanical ventilation may be complicated by barotrauma, volutrauma, and also unfavourable
      impacts on cardiovascular system and organ perfusion. Moreover, prolonged mechanical
      ventilation enhances the risk of nosocomial pneumonia. So it is Important to minimize the
      duration of mechanical ventilation and perform extubation as soon as possible. In recent
      years, development of numerous models of artificial respiration, which could support
      spontaneous breathing, has made it possible to gradually decrease the mechanical ventilatory
      support.

      From these new modes, PSV (pressure-support ventilation) which is a well known weaning mode
      will be compared in our study to a new weaning mode which is a volume support ventilation
      (VSV).

      VSV could be viewed as "PRVC for spontaneous breathing" as it delivers a variable pressure to
      meet a target VT.

        -  The ventilator gives a test breath with an inspiratory pressure of 10 cmH2O above PEEP
           (5 cmH2O in earlier software versions)

        -  It measures the volume delivered and calculates system Compliance

        -  For each subsequent breath, the ventilator calculates compliance of the previous breath
           and adjusts the inspiratory pressure level (pressure level) to achieve the set VT on the
           next breath

        -  The ventilator will not change the inspiratory pressure by more than 3 cm H2O from one
           breath to the next

        -  Maximum available inspiratory pressure level is 5 cm H2O below the preset upper pressure
           limit (alarm will sound at this point and the breath will switch into exhalation)

        -  The minimum pressure limit is the baseline setting (PEEP)

        -  If apnea occurs, back up pressure control is activated and an alarm sounds

        -  If Auto mode is on and patient becomes apneic, the mode will automatically switch to
           PRVC(pressure regulated volume control).

      In PSV patients in whom a 8 cm H2O pressure support level could be achieved,a 2-h trial of
      spontaneous breathing with this pressure support level will performed before extubation .

      In the VSV group, VT(tidal volume) will be adjusted at 6 ml/ Kg and If the patients showed
      good tolerance with an acceptable ABG (arterial blood gas)analysis (pH o7.35, PaO2(partial
      pressure of arterial oxygen)/FIO2 .150 with an FIO2(fraction of inspired oxygen) f 40%, RR
      (respiratory rate) f 35 breaths/min), they will ventilated for 2-h trial of spontaneous
      breathing and then extubated
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: The study group will be assigned to SIMV-VC for at least 48 hours . Patients will be assessed daily for fulfillment of criteria of readiness to wean according to European Respiratory Society guidelines (ERS guidelines ).
After fulfillment of ERS weaning criteria patients will be consequently divided into two equal groups: 1. 25 patients will be assigned to PSV weaning mode.
2. 25 patients will be assigned to VSV weaning mode. In PSV weaning group , PS will be adjusted 8 cm H2O. In VSV weaning group ,VT will be adjusted 6 ml/ Kg. Extubation will be done after successful spontaneous breathing trial according to ERS guidelines .
primary purpose: Supportive Care
masking: None (Open Label)
measure: Success rate
time frame: the first 48 hours after ex-tubation from mechanical ventilation .
description: Assess success rate of PSV and VSV in weaning of COPD patients .Weaning success is defined as extubation and the absence of ventilatory support 48h following the extubation .
measure: Detection of response to both modes
time frame: the first 48 hours after ex-tubation from mechanical ventilation .
description: if there was a decrease in the total weaning time ,assisted ventilation time and total time of mechanical ventilation .
measure: Number of weaning trials
time frame: the first 48 hours after ex-tubation from mechanical ventilation .
description: Detection of number of spontaneous breathing trials needed for weaning among both modes
arm group label: PSV mode
arm group type: Active Comparator
description: PSV weaning group
arm group label: VSV mode
arm group type: Experimental
description: VSV weaning group
intervention type: Procedure
intervention name: pressure support ventilation mode
description: PSV is the sole mode of mechanical ventilation and will be used as a weaning mode in mechanically ventilated chronic obstructive pulmonary disease patients,In PSV weaning group , PS(pressure support) will be adjusted at 8 cmH2O until 2-h successful spontaneous breathing trial parameters according to ERS(European Respiratory Society) guidelines will be achieved and then patient will ex-tubated.
arm group label: PSV mode
intervention type: Procedure
intervention name: volume support ventilation mode
description: VSV mode could be viewed as "PRVC for spontaneous breathing" as it delivers a variable pressure to meet a target VT. VSV will be used as a weaning mode in mechanically ventilated chronic obstructive pulmonary disease patients,In VSV weaning group ,VT(tidal volume ) will be adjusted at 6 ml/ Kg until 2-h successful spontaneous breathing trial parameters according to ERS guidelines will be achieved and then patient will ex-tubated.
arm group label: VSV mode
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Maha Ghanem, Prof
phone: 00201227694434
email: mahaghanem@hotmail.com
last name: Hoda Makhlouf, Prof
phone: 00201001529442
email: hamakhlouf@yahoo.com
facility: 
country: Egypt
citation: Barnes PJ, Celli BR. Systemic manifestations and comorbidities of COPD. Eur Respir J. 2009 May;33(5):1165-85. doi: 10.1183/09031936.00128008.
PMID: 19407051
citation: Sancar NK, Ozcan PE, Senturk E, Selek C, Cakar N. The Comparison of Pressure (PSV) and Volume Support Ventilation (VSV) as a 'Weaning' Mode. Turk J Anaesthesiol Reanim. 2014 Aug;42(4):170-5. doi: 10.5152/TJAR.2014.61687. Epub 2014 May 29.
PMID: 27366416
citation: Ruiz-Santana S, Garcia Jimenez A, Esteban A, Guerra L, Alvarez B, Corcia S, Gudin J, Martinez A, Quintana E, Armengol S, et al. ICU pneumonias: a multi-institutional study. Crit Care Med. 1987 Oct;15(10):930-2. doi: 10.1097/00003246-198710000-00007.
PMID: 3652708
citation: Boles JM, Bion J, Connors A, Herridge M, Marsh B, Melot C, Pearl R, Silverman H, Stanchina M, Vieillard-Baron A, Welte T. Weaning from mechanical ventilation. Eur Respir J. 2007 May;29(5):1033-56. doi: 10.1183/09031936.00010206.
PMID: 17470624
responsible party type: Principal Investigator
investigator affiliation: Assiut University
investigator full name: Alaa Mohammed Taghyan
investigator title: Principal Investigator
mesh term: Lung Diseases, Obstructive
mesh term: Pulmonary Disease, Chronic Obstructive
sharing ipd: No