<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/NCT03804398</url>
  </required_header>
  <id_info>
    <org_study_id>FujianUnionAnethesiaOne</org_study_id>
    <nct_id>NCT03804398</nct_id>
  </id_info>
  <brief_title>Effect of Optimal Positive End-Expiratory Pressure on Oxygenation and Intrapulmonary Shunt During One-lung Ventilation</brief_title>
  <official_title>Effect of Compliance Guided an Optimal Positive End-Expiratory Pressure on Arterial Oxygenation and Intrapulmonary Shunt During One-lung Ventilation</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Fujian Medical University Union Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Fujian Medical University Union Hospital</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>
      To observe the effect of compliance guided an optimal Positive End-Expiratory&#xD;
      Pressure（PEEP）on arterial oxygenation and intrapulmonary shunt during one-lung&#xD;
      ventilation(OLV)，and discuss the lung protective effect of optimal PEEP during one-lung&#xD;
      ventilation.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Sixty patients undergoing thoracic surgery were randomly allocated to the study or control&#xD;
      group.Patients were monitored for electrocardiogram, pulse oximetry, and non-invasive blood&#xD;
      pressure,20 gauge cannula needle for radial artery catheterization under local anesthesia,&#xD;
      monitoring ABP.,the right subclavian vein was selected for catheterization under local&#xD;
      anesthesia,monitoring CVP.Anesthesia was induced with sufentanil 0.4 μg/kg, propofol 2 mg/kg,&#xD;
      and cisatracurium 0.3 mg/kg.The trachea was intubated with a double-lumen tube (DLT)，37F for&#xD;
      male and 35F for female patients.Tube position was confirmed by bronchoscopy in the supine&#xD;
      and lateral positions.Anesthesia was maintained with sevoﬂurane 1.0-1.5 vol%，propofol 2-4&#xD;
      mg/(kg·h) and remifentanil 0.1-0.2 μg/(kg·min) and intermittent cisatracurium 0.06-0.1&#xD;
      mg/kg.The lungs were initially ventilated using a volume-controlled ventilation mode,two-lung&#xD;
      ventilation(TLV):tidal volume (VT) 8 ml/kg,respiratory rate 12-14 bpm, inspiratory:expiratory&#xD;
      (I:E) ratio 1:2, in 60% oxygen without PEEP. During OLV, VT was reduced to 6 ml/kg,OLV was&#xD;
      initiated at the moment of skin incision.Both groups received an alveolar recruitment&#xD;
      maneuver(increase inspiratory pressure to 30cmH2O for 10s) at the 10min after one-lung&#xD;
      ventilation. After the alveolar recruitment maneuver,the study group titrate PEEP from&#xD;
      4cmH2O,increased in 2cmH2O steps and hold at each step for 1min,and the static pulmonary&#xD;
      compliance(Cst) would be record.Optimal PEEP was determined until the maximal static&#xD;
      pulmonary compliance was obtained.In the control group at PEEP level of 5 cmH2O was&#xD;
      established and maintained during the study period.Blood gas analyses, respiratory variables,&#xD;
      and hemodynamic variables were recorded at 6 different time points:10 min after TLV(T0),&#xD;
      10min after OLV(T1), 30min after PEEP(T2), 60min after PEEP(T3), 10min after the end OLV(T4)&#xD;
      and 20min after extubation(T5).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 14, 2018</start_date>
  <completion_date type="Actual">November 1, 2018</completion_date>
  <primary_completion_date type="Actual">October 11, 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>Double (Participant, Care Provider)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>arterial oxygenation</measure>
    <time_frame>24 hours</time_frame>
    <description>To observe the effect of compliance guided an optimal Positive End-Expiratory Pressure（PEEP）on arterial oxygenation</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">56</enrollment>
  <condition>Lung Cancer</condition>
  <arm_group>
    <arm_group_label>optimal PEEP group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The study group titrate PEEP from 4cmH2O,increased in 2cmH2O steps and hold at each step for 1min,and the static pulmonary compliance(Cst) would be record.Optimal PEEP was determined until the maximal static pulmonary compliance was obtained</description>
  </arm_group>
  <arm_group>
    <arm_group_label>PEEP level of 5 cmH2O group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>In the control group at PEEP level of 5 cmH2O was established and maintained during the study period</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>compliance guided an optimal Positive End-Expiratory Pressure</intervention_name>
    <description>The study groups received an alveolar recruitment maneuver(increase inspiratory pressure to 30cmH2O for 10s) at the 10min after one-lung ventilation. After the alveolar recruitment maneuver,the study group titrate PEEP from 4cmH2O,increased in 2cmH2O steps and hold at each step for 1min,and the static pulmonary compliance(Cst) would be record.Optimal PEEP was determined until the maximal static pulmonary compliance was obtained.</description>
    <arm_group_label>optimal PEEP group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>PEEP level of 5 cmH2O</intervention_name>
    <description>In the control group at PEEP level of 5 cmH2O was established and maintained during the study period</description>
    <arm_group_label>PEEP level of 5 cmH2O group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Aged 18 yr to 65 yr&#xD;
&#xD;
          -  Body mass index(BMI)18-28kg/m2&#xD;
&#xD;
          -  American Society of Anesthesiologists Physical Status Classifications I to II&#xD;
&#xD;
          -  Normal cardiac and pulmonary function&#xD;
&#xD;
          -  Diagnosed with uncomplicated lung cancer and was to receive video-assist thoracoscopic&#xD;
             lobectomy under general anesthesia.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Forced expiratory volume at one second/forced vital capacity &lt;70%&#xD;
&#xD;
          -  Asthma&#xD;
&#xD;
          -  Chronic obstructive pulmonary disease&#xD;
&#xD;
          -  Acute lung infection&#xD;
&#xD;
          -  Past history of thoracic surgery&#xD;
&#xD;
          -  Cardiac,hepatic,renal and endocrine diseases&#xD;
&#xD;
          -  Preoperative glucocorticoid medication&#xD;
&#xD;
          -  Preoperative chemotherapy&#xD;
&#xD;
          -  Peripheral oxygen saturation（SpO2） kept below 90% for more than 10 minutes during&#xD;
             operation&#xD;
&#xD;
          -  Blood transfusion during operation&#xD;
&#xD;
          -  Duration of one-lung ventilation less than an hour&#xD;
&#xD;
          -  Occurrence of severe complications like allergic shock&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Wenhua chen</last_name>
    <role>Principal Investigator</role>
    <affiliation>Fujian Medical University Union Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>FujianUnionHospital</name>
      <address>
        <city>Fuzhou</city>
        <state>Fujian</state>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>January 10, 2019</study_first_submitted>
  <study_first_submitted_qc>January 13, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 15, 2019</study_first_posted>
  <last_update_submitted>January 13, 2019</last_update_submitted>
  <last_update_submitted_qc>January 13, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 15, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </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/NCT03804398
org study id: FujianUnionAnethesiaOne
nct id: NCT03804398
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
To observe the effect of compliance guided an optimal Positive End-Expiratory
      Pressure（PEEP）on arterial oxygenation and intrapulmonary shunt during one-lung
      ventilation(OLV)，and discuss the lung protective effect of optimal PEEP during one-lung
      ventilation.
Sixty patients undergoing thoracic surgery were randomly allocated to the study or control
      group.Patients were monitored for electrocardiogram, pulse oximetry, and non-invasive blood
      pressure,20 gauge cannula needle for radial artery catheterization under local anesthesia,
      monitoring ABP.,the right subclavian vein was selected for catheterization under local
      anesthesia,monitoring CVP.Anesthesia was induced with sufentanil 0.4 μg/kg, propofol 2 mg/kg,
      and cisatracurium 0.3 mg/kg.The trachea was intubated with a double-lumen tube (DLT)，37F for
      male and 35F for female patients.Tube position was confirmed by bronchoscopy in the supine
      and lateral positions.Anesthesia was maintained with sevoﬂurane 1.0-1.5 vol%，propofol 2-4
      mg/(kg·h) and remifentanil 0.1-0.2 μg/(kg·min) and intermittent cisatracurium 0.06-0.1
      mg/kg.The lungs were initially ventilated using a volume-controlled ventilation mode,two-lung
      ventilation(TLV):tidal volume (VT) 8 ml/kg,respiratory rate 12-14 bpm, inspiratory:expiratory
      (I:E) ratio 1:2, in 60% oxygen without PEEP. During OLV, VT was reduced to 6 ml/kg,OLV was
      initiated at the moment of skin incision.Both groups received an alveolar recruitment
      maneuver(increase inspiratory pressure to 30cmH2O for 10s) at the 10min after one-lung
      ventilation. After the alveolar recruitment maneuver,the study group titrate PEEP from
      4cmH2O,increased in 2cmH2O steps and hold at each step for 1min,and the static pulmonary
      compliance(Cst) would be record.Optimal PEEP was determined until the maximal static
      pulmonary compliance was obtained.In the control group at PEEP level of 5 cmH2O was
      established and maintained during the study period.Blood gas analyses, respiratory variables,
      and hemodynamic variables were recorded at 6 different time points:10 min after TLV(T0),
      10min after OLV(T1), 30min after PEEP(T2), 60min after PEEP(T3), 10min after the end OLV(T4)
      and 20min after extubation(T5).
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: Double (Participant, Care Provider)
measure: arterial oxygenation
time frame: 24 hours
description: To observe the effect of compliance guided an optimal Positive End-Expiratory Pressure（PEEP）on arterial oxygenation
arm group label: optimal PEEP group
arm group type: Experimental
description: The study group titrate PEEP from 4cmH2O,increased in 2cmH2O steps and hold at each step for 1min,and the static pulmonary compliance(Cst) would be record.Optimal PEEP was determined until the maximal static pulmonary compliance was obtained
arm group label: PEEP level of 5 cmH2O group
arm group type: Active Comparator
description: In the control group at PEEP level of 5 cmH2O was established and maintained during the study period
intervention type: Device
intervention name: compliance guided an optimal Positive End-Expiratory Pressure
description: The study groups received an alveolar recruitment maneuver(increase inspiratory pressure to 30cmH2O for 10s) at the 10min after one-lung ventilation. After the alveolar recruitment maneuver,the study group titrate PEEP from 4cmH2O,increased in 2cmH2O steps and hold at each step for 1min,and the static pulmonary compliance(Cst) would be record.Optimal PEEP was determined until the maximal static pulmonary compliance was obtained.
arm group label: optimal PEEP group
intervention type: Device
intervention name: PEEP level of 5 cmH2O
description: In the control group at PEEP level of 5 cmH2O was established and maintained during the study period
arm group label: PEEP level of 5 cmH2O group
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: Wenhua chen
role: Principal Investigator
affiliation: Fujian Medical University Union Hospital
facility: 
country: China
responsible party type: Sponsor