<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/NCT04421976</url>
  </required_header>
  <id_info>
    <org_study_id>DP-Neurosurgery</org_study_id>
    <nct_id>NCT04421976</nct_id>
  </id_info>
  <brief_title>Driving Pressure in Neurosurgery</brief_title>
  <acronym>DPNS</acronym>
  <official_title>Driving Pressure for Early Postoperative Redistribution of Pulmonary Ventilation in Neurosurgery : A Prospective Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Capital Medical University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Capital Medical 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>
      The effect of driving pressure (DP)-guided positive end expiratory pressure (PEEP) on early&#xD;
      postoperative pulmonary ventilation is to be determined for patients undergoing neurosurgery.&#xD;
      Patients are recruited to receive volume controlled ventilation with either a fixed PEEP&#xD;
      (5cmH2O) or DP titrated PEEP. Early postoperative regional distribution of lung ventilation,&#xD;
      expressed as global inhomogeneity (GI) is evaluated by electrical impedance tomography (EIT),&#xD;
      a noninvasive, radiation free modality. Center of ventilation (COV) by EIT, as well as the&#xD;
      lung ultrasonography（LUS), perioperative ventilatory parameters, arterial oxygenation index&#xD;
      (PaO2/FiO2) , serum indicators and postoperative pulmonary complications are secondary&#xD;
      outcome variables.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      After screened for preoperative risk factors, 44 patients undergoing elective neurosurgery&#xD;
      and planned to be extubated in the operating room are randomly assigned to two groups: (1)&#xD;
      PEEP = 5cmH2O; (2) driving pressure (DP)-guided PEEP. The ventilation protocol consists of&#xD;
      volume-controlled mechanical ventilation (Datex Ohmeda S/5 Advance; General Electric Company&#xD;
      Healthcare, Helsinki, Finland) at a tidal volume (VT) of 8 ml/kg predicted body weight (PBW),&#xD;
      fresh gas of 2 litre /min, inspiratory to expiratory ratio of 1:2, and a respiratory rate&#xD;
      adjusted to normocapnia (arterial carbon dioxide partial pressure between 35 and 45 mmHg).&#xD;
      For group 2, trial for the lowest DP was started 10 min after position adjustment by&#xD;
      increasing PEEP from 2 to 10 cm H2O incrementally. DP was calculated as &quot;plateau pressure -&#xD;
      PEEP&quot;. Each PEEP level was maintained for 10 respiratory cycles, with DP in the last cycle&#xD;
      recorded. Then the PEEP level producing the lowest DP was identified and maintained&#xD;
      intraoperatively. A plateau pressure of no more than 30 cmH2O is targeted in each group.&#xD;
      Early postoperative distribution of regional ventilation global inhomogeneity (GI) is the&#xD;
      primary endpoint evaluated by EIT (electrical impedance tomography), which was performed by a&#xD;
      trained technician who is blinded to randomization. Center of ventilation (COV) by EIT, lung&#xD;
      ultrasonography（LUS) , and arterial blood gas are evaluated, with inflammatory and oxidative&#xD;
      mediators tested from venous sample. Brain relaxation will be scored by the neurosurgeon.&#xD;
      Postoperative pulmonary complications within 3 days are also recorded.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 21, 2020</start_date>
  <completion_date type="Actual">July 1, 2021</completion_date>
  <primary_completion_date type="Actual">April 1, 2021</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>Prevention</primary_purpose>
    <masking>Double (Participant, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>early postoperative overall spatial distribution of pulmonary ventilation</measure>
    <time_frame>immediately after extubation</time_frame>
    <description>global inhomogeneity index (GI): overall degree of spatial heterogeneity of ventilation. GI is measured by electrical impedance tomography (EIT). A smaller GI index represents a more homogeneous distribution, and a larger GI index indicates a more inhomogeneous ventilation.</description>
  </primary_outcome>
  <other_outcome>
    <measure>Melbourne Group Scale version 2 (MGS-2)</measure>
    <time_frame>within the first 3 days after surgery</time_frame>
    <description>Melbourne Group Scale version 2 (MGS-2): Temperature &gt;38°C; White cell count &gt;11.2 or use of respiratory antibiotics; Physician diagnosis of pneumonia or chest infection; Chest X-ray findings of atelectasis/consolidation; Production of purulent (yellow/green) sputum different from preoperative sputum; Positive results upon sputum microbiological analysis; oxygen saturation by pulse oximetry (SpO2)&lt;90% in ambient air; Re-admission to or prolonged stay (&gt;36 h) in the intensive care unit/high dependency unit for respiratory problems. A postoperative pulmonary complication (PPC) was diagnosed if 4 or more of the 8 factors were present.</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">55</enrollment>
  <condition>Neurosurgery</condition>
  <arm_group>
    <arm_group_label>Conventional PEEP</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>PEEP = 5 cmH2O</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Driving pressure (DP) guided-PEEP</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>PEEP is increased from 2 to 10 cm H2O incrementally. Each PEEP level is maintained for 10 respiratory cycles, with DP in the last cycle recorded. Then the PEEP level producing the lowest DP will be identified and maintained intraoperatively.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>PEEP</intervention_name>
    <description>Driving pressure (DP) is calculated as &quot;plateau pressure - PEEP&quot;. 10min after position adjustment, PEEP is increased from 2 to 10 cm H2O incrementally. Each PEEP level is maintained for 10 respiratory cycles, with DP in the last cycle recorded. Then the PEEP level producing the lowest DP will be identified and maintained intraoperatively.</description>
    <arm_group_label>Conventional PEEP</arm_group_label>
    <arm_group_label>Driving pressure (DP) guided-PEEP</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Informed consent has been obtained&#xD;
&#xD;
          -  Elective neurosurgery&#xD;
&#xD;
          -  Expected ventilation duration &gt; 2 hours&#xD;
&#xD;
          -  Scheduled to be extubated in the operation&#xD;
&#xD;
          -  American Society of Anesthesiologists (ASA) physical status &gt;2&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Mechanical ventilation of &gt; 1 hour within the last 2 weeks before surgery&#xD;
&#xD;
          -  Dysphagia resulting from preoperative cranial nerve damage&#xD;
&#xD;
          -  Body mass index ≥ 35 kg/m2&#xD;
&#xD;
          -  Acute respiratory failure (pneumonia, acute lung injury or acute respiratory distress&#xD;
             syndrome)&#xD;
&#xD;
          -  Emergency surgery&#xD;
&#xD;
          -  Severe cardiac disease&#xD;
&#xD;
          -  Progressive neuromuscular illness&#xD;
&#xD;
          -  Pregnancy&#xD;
&#xD;
          -  Refusal to participate&#xD;
&#xD;
          -  Contradicted to EIT scan or lung ultrasound scan&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ruquan Han, MD,PHD</last_name>
    <role>Study Director</role>
    <affiliation>Beijing Tiantan Hospital affiliated with Capital Medical University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Department of Anesthesiology,Beijing Tiantan Hospital, Capital Medical University</name>
      <address>
        <city>Beijing</city>
        <state>Beijing</state>
        <zip>100070</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>July 2021</verification_date>
  <study_first_submitted>May 29, 2020</study_first_submitted>
  <study_first_submitted_qc>June 4, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 9, 2020</study_first_posted>
  <last_update_submitted>July 1, 2021</last_update_submitted>
  <last_update_submitted_qc>July 1, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">July 6, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Capital Medical University</investigator_affiliation>
    <investigator_full_name>Wei Zhang</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <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/NCT04421976
org study id: DP-Neurosurgery
nct id: NCT04421976
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
The effect of driving pressure (DP)-guided positive end expiratory pressure (PEEP) on early
      postoperative pulmonary ventilation is to be determined for patients undergoing neurosurgery.
      Patients are recruited to receive volume controlled ventilation with either a fixed PEEP
      (5cmH2O) or DP titrated PEEP. Early postoperative regional distribution of lung ventilation,
      expressed as global inhomogeneity (GI) is evaluated by electrical impedance tomography (EIT),
      a noninvasive, radiation free modality. Center of ventilation (COV) by EIT, as well as the
      lung ultrasonography（LUS), perioperative ventilatory parameters, arterial oxygenation index
      (PaO2/FiO2) , serum indicators and postoperative pulmonary complications are secondary
      outcome variables.
After screened for preoperative risk factors, 44 patients undergoing elective neurosurgery
      and planned to be extubated in the operating room are randomly assigned to two groups: (1)
      PEEP = 5cmH2O; (2) driving pressure (DP)-guided PEEP. The ventilation protocol consists of
      volume-controlled mechanical ventilation (Datex Ohmeda S/5 Advance; General Electric Company
      Healthcare, Helsinki, Finland) at a tidal volume (VT) of 8 ml/kg predicted body weight (PBW),
      fresh gas of 2 litre /min, inspiratory to expiratory ratio of 1:2, and a respiratory rate
      adjusted to normocapnia (arterial carbon dioxide partial pressure between 35 and 45 mmHg).
      For group 2, trial for the lowest DP was started 10 min after position adjustment by
      increasing PEEP from 2 to 10 cm H2O incrementally. DP was calculated as "plateau pressure -
      PEEP". Each PEEP level was maintained for 10 respiratory cycles, with DP in the last cycle
      recorded. Then the PEEP level producing the lowest DP was identified and maintained
      intraoperatively. A plateau pressure of no more than 30 cmH2O is targeted in each group.
      Early postoperative distribution of regional ventilation global inhomogeneity (GI) is the
      primary endpoint evaluated by EIT (electrical impedance tomography), which was performed by a
      trained technician who is blinded to randomization. Center of ventilation (COV) by EIT, lung
      ultrasonography（LUS) , and arterial blood gas are evaluated, with inflammatory and oxidative
      mediators tested from venous sample. Brain relaxation will be scored by the neurosurgeon.
      Postoperative pulmonary complications within 3 days are also recorded.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Double (Participant, Outcomes Assessor)
measure: early postoperative overall spatial distribution of pulmonary ventilation
time frame: immediately after extubation
description: global inhomogeneity index (GI): overall degree of spatial heterogeneity of ventilation. GI is measured by electrical impedance tomography (EIT). A smaller GI index represents a more homogeneous distribution, and a larger GI index indicates a more inhomogeneous ventilation.
measure: Melbourne Group Scale version 2 (MGS-2)
time frame: within the first 3 days after surgery
description: Melbourne Group Scale version 2 (MGS-2): Temperature >38°C; White cell count >11.2 or use of respiratory antibiotics; Physician diagnosis of pneumonia or chest infection; Chest X-ray findings of atelectasis/consolidation; Production of purulent (yellow/green) sputum different from preoperative sputum; Positive results upon sputum microbiological analysis; oxygen saturation by pulse oximetry (SpO2)<90% in ambient air; Re-admission to or prolonged stay (>36 h) in the intensive care unit/high dependency unit for respiratory problems. A postoperative pulmonary complication (PPC) was diagnosed if 4 or more of the 8 factors were present.
arm group label: Conventional PEEP
arm group type: Placebo Comparator
description: PEEP = 5 cmH2O
arm group label: Driving pressure (DP) guided-PEEP
arm group type: Experimental
description: PEEP is increased from 2 to 10 cm H2O incrementally. Each PEEP level is maintained for 10 respiratory cycles, with DP in the last cycle recorded. Then the PEEP level producing the lowest DP will be identified and maintained intraoperatively.
intervention type: Procedure
intervention name: PEEP
description: Driving pressure (DP) is calculated as "plateau pressure - PEEP". 10min after position adjustment, PEEP is increased from 2 to 10 cm H2O incrementally. Each PEEP level is maintained for 10 respiratory cycles, with DP in the last cycle recorded. Then the PEEP level producing the lowest DP will be identified and maintained intraoperatively.
arm group label: Conventional PEEP
arm group label: Driving pressure (DP) guided-PEEP
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: No
last name: Ruquan Han, MD,PHD
role: Study Director
affiliation: Beijing Tiantan Hospital affiliated with Capital Medical University
facility: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Capital Medical University
investigator full name: Wei Zhang
investigator title: Principal Investigator
sharing ipd: No