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/NCT05993780</url>
    </required_header>
    <id_info>
      <org_study_id>PamukkaleUSyuksel-001</org_study_id>
      <nct_id>NCT05993780</nct_id>
    </id_info>
    <brief_title>An Evaluation of End-Expiratory Lung Volume and Pulmonary Mechanics With Different PEEP Levels in Mechanical Ventilation in ARDS Patients</brief_title>
    <official_title>An Evaluation of End-Expiratory Lung Volume and Pulmonary Mechanics With Different PEEP Levels in Mechanical Ventilation in ARDS Patients</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Pamukkale University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Pamukkale 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>
        ARDS management is quite complex, and mortality is high. PEEP titration is very important in&#xD;
        mechanical ventilation. However, the most appropriate approach for PEEP titration has yet to&#xD;
        be determined. Currently, the emphasis is on focused PEEP implementation. The present study&#xD;
        aimed to evaluate the volume gain at different PEEP levels over the pressure-volume curve,&#xD;
        the changes in EELV measured by the modified multiple nitrogen wash-out/wash-in technique,&#xD;
        and the compliance with respiratory mechanics.&#xD;
  &#xD;
        14 adult ARDS patients undergoing invasive mechanical ventilation were included in the study.&#xD;
        According to the Berlin Criteria, There were two mild, seven moderates, and five severe ARDS&#xD;
        patients. FRC and EELV with decreased PEEP titration estimates (5 cmH2O) were measured by the&#xD;
        multiple nitrogen wash-out/washin technique. Gain and compliance values were measured over&#xD;
        the dynamic pressure-volume curves created by the intracheal pressure sensor.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The present study was conducted in the Anesthesiology and Reanimation Intensive Care Units of&#xD;
        Pamukkale University Hospital with the approval of Pamukkale University Non-Interventional&#xD;
        Clinical Research Ethics Committee dated 13.07.2021 and 13th board meeting numbered&#xD;
        60116787-020/83538. Between August 2021 and August 2022, 17 patients were included over 18&#xD;
        years of age who met the Berlin criteria and were diagnosed with ARDS sedated, intubated, and&#xD;
        mechanically ventilated. Informed written consent was obtained from the relatives.&#xD;
  &#xD;
        Patients included in the study were connected to a CARESCAPE R860 (GE Healthcare) mechanical&#xD;
        ventilator. Rocuronium bromide was administered intravenously to eliminate the spontaneous&#xD;
        respiratory effort and opioids for sedation. Tidal volume was adjusted as 6 ml/kg according&#xD;
        to the estimated body weight; the respiratory rate was adjusted to ensure normocarbia in&#xD;
        blood gas analysis; FiO2 was adjusted as PaO2 55 to 80 mmHg; end-inspiratory pause was&#xD;
        adjusted to 20%, and inspiratory/expiratory ratio was adjusted as 1:2.&#xD;
  &#xD;
        The ECOV-X (GE Healthcare) module was attached to the ventilator for gas measurements and&#xD;
        allowed to warm up. A spirometer kit was inserted between the Y-piece in the ventilator&#xD;
        circuit and the bacterial/viral filter with heat and moisture-retaining properties. An&#xD;
        intratracheal pressure sensor was inserted to measure pressure levels independent of circuit&#xD;
        and tube resistance and to evaluate them on the SpiroDynamics (GE Healthcare) application.&#xD;
        EELV was measured with the ECOV-X (GE Healthcare) module using a modified NMBW technique with&#xD;
        the change in FiO2. EELV was calculated using VO2 (oxygen consumption) and VCO2 (carbon&#xD;
        dioxide production). After all the connections were completed, the VO2 and VCO2 values of the&#xD;
        patients were measured. The PEEP titration procedure called Lung INview (GE Healthcare) was&#xD;
        initiated in patients whose values stabilized within 30 min. Before the measurement, a&#xD;
        recruitment maneuver was performed for 30-40 s at a PEEP level of 20 cmH2O. At four different&#xD;
        PEEP levels of 15, 10, 5, and 0 cmH2O, a decreasing PEEP trial was performed, and the&#xD;
        measurement results were recorded.&#xD;
  &#xD;
        For the same PEEP levels, the shunt fraction decreases when a decreasing PEEP maneuver is&#xD;
        used instead of an increasing PEEP maneuver. This suggests that the relationship between&#xD;
        optimal PEEP and maximum compliance may be more accurate. Therefore, decreasing PEEP trials&#xD;
        was preferred as the study protocol.&#xD;
  &#xD;
        The measurement time at each PEEP level was chosen as 10 minutes. At the end of the&#xD;
        measurement, static compliance was measured by applying an end-inspiratory pause. Tidal&#xD;
        volume, peak, and driving pressure were recorded at each step. Respiratory system elastance&#xD;
        was calculated using the equation by Henderson et al.(respiratory system elastance = driving&#xD;
        pressure/tidal volume). The static strain was calculated using the equation using the tidal&#xD;
        volume at the relevant PEEP value (static strain =VPEEP/FRC). The pressure-volume curve&#xD;
        generated by the intratracheal pressure sensor at each PEEP level was evaluated using the&#xD;
        SpiroDynamics application. A dynamic compliance curve was generated during the analysis, and&#xD;
        volume changes in this curve were determined at each PEEP level. The difference in EELV at&#xD;
        two different PEEP levels during a descending PEEP trial was calculated as ∆EELV, and the&#xD;
        difference between ∆EELV and the volume derived from the pressure-volume curve was calculated&#xD;
        as &quot;volume gain&quot; (gain = ∆EELV - volume derived from the curve). The estimated lung volume&#xD;
        recovered was calculated using the formula ∆EELV - (∆PEEP x Compliance PEEPlow) and compared&#xD;
        with the volume gain. The efficiency of the volume gains concept as an indicator of the&#xD;
        volume gained by alveolar recruitment and its role in personalized PEEP titration was&#xD;
        evaluated.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">August 2, 2021</start_date>
    <completion_date type="Actual">August 26, 2021</completion_date>
    <primary_completion_date type="Actual">August 26, 2021</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>N/A</allocation>
      <intervention_model>Single Group Assignment</intervention_model>
      <primary_purpose>Treatment</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Does volume gain indicate recruited lung volume?</measure>
      <time_frame>Patients were ventilated for 10 minutes at each PEEP level.Measurement was taken after 10 minutes.]</time_frame>
      <description>A dynamic compliance curve was generated during the analysis, and volume changes in this curve were determined at each PEEP level. The difference in EELV at two different PEEP levels during a descending PEEP trial was calculated as ∆EELV, and the difference between ∆EELV and the volume derived from the pressure-volume curve was calculated as &quot;volume gain&quot; (gain = ∆EELV - volume derived from the curve). The estimated lung volume recovered was calculated using the formula ∆EELV - (∆PEEP x Compliance PEEPlow) and compared with the volume gain.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Static compliance correlation with volume gain.</measure>
      <time_frame>Patients were ventilated for 10 minutes at each PEEP level.Measurement was taken after 10 minutes.</time_frame>
      <description>After measuring the volume gain, its correlation with static compliance was examined. The measurement time at each PEEP level was chosen as 10 minutes. At the end of the measurement, static compliance was measured by applying an end-inspiratory pause</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Calculation of respiratory system elastance and its correlation with volume gain.</measure>
      <time_frame>Patients were ventilated for 10 minutes at each PEEP level.Measurement was taken after 10 minutes.</time_frame>
      <description>Respiratory system elastance was calculated using the equation (respiratory system elastance = driving pressure/tidal volume).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Examination of the relationship between static strain and volume gain.</measure>
      <time_frame>Patients were ventilated for 10 minutes at each PEEP level.Measurement was taken after 10 minutes.</time_frame>
      <description>Static strain; calculated by the ratio of tidal volume to FRC at the relevant PEEP level.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Investigation of the correlation between driving pressure and volume gain</measure>
      <time_frame>Patients were ventilated for 10 minutes at each PEEP level.Measurement was taken after 10 minutes.</time_frame>
      <description>During the measurements, volume gain and driving pressure at different PEEP levels were recorded and their correlations were examined.</description>
    </secondary_outcome>
    <other_outcome>
      <measure>Hemodynamic parameters of patient with ARDS were measured during different PEEP measurement.</measure>
      <time_frame>Measurements were taken after 10 minutes of ventilating at the PEEP level.</time_frame>
      <description>Systolic blood pressure, diastolic blood pressure and heart rate, peripheral oxygen saturation at different PEEP levels were recorded.</description>
    </other_outcome>
    <other_outcome>
      <measure>Arterial blood gas analysis</measure>
      <time_frame>Measurements were taken after 10 minutes of ventilating at the PEEP level.</time_frame>
      <description>At all PEEP levels, pH, PaO2 (mmHg), PaCO2 (mmHg), SaO2 (%) were measured in arterial blood gas.</description>
    </other_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Actual">14</enrollment>
    <condition>Ards</condition>
    <arm_group>
      <arm_group_label>ARDS patient</arm_group_label>
      <arm_group_type>Other</arm_group_type>
      <description>14 patients with ARDS were included in the study. It was planned as a single group.</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>No drugs or biologial agents were used in our trial</intervention_name>
      <description>Before the measurement, a recruitment maneuver was performed for 30-40 s at a PEEP level of 20 cmH2O. At four different PEEP levels of 15, 10, 5, and 0 cmH2O, a decreasing PEEP trial was performed, and the measurement results were recorded.The measurement time at each PEEP level was chosen as 10 minutes. At the end of the measurement, static compliance was measured by applying an end-inspiratory pause. Respiratory system elastance,static strain volume gain was calculated.The estimated lung volume recovered was calculated using the formula ∆EELV - (∆PEEP x Compliance PEEPlow) and compared with the volume gain.</description>
      <arm_group_label>ARDS patient</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Patients diagnosed with ARDS according to the Berlin criteria&#xD;
  &#xD;
            -  Berlin definition criteria: (1) presence of acute hypoxemic respiratory failure, (2)&#xD;
               onset within 7 days of insult, or or new (within 7 days) or worsening respiratory&#xD;
               symptoms; (3) bilateral opacities on chest x-ray or CT not fully explained by&#xD;
               effusions, lobar or lung collapse, or nodules; and (4) cardiac failure not primary&#xD;
               cause of acute respiratory failure.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Patients with severe cardiovascular instability (Mean arterial pressure &lt;60 mmHg ,&#xD;
               Pulse &lt;45 or &gt;150), Patients with pneumothorax, Patients who have undergone&#xD;
               pneumonectomy operation, Patients with Lung Transplantation, Patients with thoracic&#xD;
               deformity, ARDS patients with cor pulmonale&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <location>
      <facility>
        <name>Pamukkale University</name>
        <address>
          <city>Denizli</city>
          <country>Turkey</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Turkey</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 31, 2023</study_first_submitted>
    <study_first_submitted_qc>August 8, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 15, 2023</study_first_posted>
    <last_update_submitted>August 8, 2023</last_update_submitted>
    <last_update_submitted_qc>August 8, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 15, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Pamukkale University</investigator_affiliation>
      <investigator_full_name>Selvinaz Yüksel Tanrıverdi</investigator_full_name>
      <investigator_title>Specialist, Department of Anesthesiology and Reanimation, MD</investigator_title>
    </responsible_party>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- 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/NCT05993780
  org study id: PamukkaleUSyuksel-001
  nct id: NCT05993780
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  ARDS management is quite complex, and mortality is high. PEEP titration is very important in
        mechanical ventilation. However, the most appropriate approach for PEEP titration has yet to
        be determined. Currently, the emphasis is on focused PEEP implementation. The present study
        aimed to evaluate the volume gain at different PEEP levels over the pressure-volume curve,
        the changes in EELV measured by the modified multiple nitrogen wash-out/wash-in technique,
        and the compliance with respiratory mechanics.
  
        14 adult ARDS patients undergoing invasive mechanical ventilation were included in the study.
        According to the Berlin Criteria, There were two mild, seven moderates, and five severe ARDS
        patients. FRC and EELV with decreased PEEP titration estimates (5 cmH2O) were measured by the
        multiple nitrogen wash-out/washin technique. Gain and compliance values were measured over
        the dynamic pressure-volume curves created by the intracheal pressure sensor.
  The present study was conducted in the Anesthesiology and Reanimation Intensive Care Units of
        Pamukkale University Hospital with the approval of Pamukkale University Non-Interventional
        Clinical Research Ethics Committee dated 13.07.2021 and 13th board meeting numbered
        60116787-020/83538. Between August 2021 and August 2022, 17 patients were included over 18
        years of age who met the Berlin criteria and were diagnosed with ARDS sedated, intubated, and
        mechanically ventilated. Informed written consent was obtained from the relatives.
  
        Patients included in the study were connected to a CARESCAPE R860 (GE Healthcare) mechanical
        ventilator. Rocuronium bromide was administered intravenously to eliminate the spontaneous
        respiratory effort and opioids for sedation. Tidal volume was adjusted as 6 ml/kg according
        to the estimated body weight; the respiratory rate was adjusted to ensure normocarbia in
        blood gas analysis; FiO2 was adjusted as PaO2 55 to 80 mmHg; end-inspiratory pause was
        adjusted to 20%, and inspiratory/expiratory ratio was adjusted as 1:2.
  
        The ECOV-X (GE Healthcare) module was attached to the ventilator for gas measurements and
        allowed to warm up. A spirometer kit was inserted between the Y-piece in the ventilator
        circuit and the bacterial/viral filter with heat and moisture-retaining properties. An
        intratracheal pressure sensor was inserted to measure pressure levels independent of circuit
        and tube resistance and to evaluate them on the SpiroDynamics (GE Healthcare) application.
        EELV was measured with the ECOV-X (GE Healthcare) module using a modified NMBW technique with
        the change in FiO2. EELV was calculated using VO2 (oxygen consumption) and VCO2 (carbon
        dioxide production). After all the connections were completed, the VO2 and VCO2 values of the
        patients were measured. The PEEP titration procedure called Lung INview (GE Healthcare) was
        initiated in patients whose values stabilized within 30 min. Before the measurement, a
        recruitment maneuver was performed for 30-40 s at a PEEP level of 20 cmH2O. At four different
        PEEP levels of 15, 10, 5, and 0 cmH2O, a decreasing PEEP trial was performed, and the
        measurement results were recorded.
  
        For the same PEEP levels, the shunt fraction decreases when a decreasing PEEP maneuver is
        used instead of an increasing PEEP maneuver. This suggests that the relationship between
        optimal PEEP and maximum compliance may be more accurate. Therefore, decreasing PEEP trials
        was preferred as the study protocol.
  
        The measurement time at each PEEP level was chosen as 10 minutes. At the end of the
        measurement, static compliance was measured by applying an end-inspiratory pause. Tidal
        volume, peak, and driving pressure were recorded at each step. Respiratory system elastance
        was calculated using the equation by Henderson et al.(respiratory system elastance = driving
        pressure/tidal volume). The static strain was calculated using the equation using the tidal
        volume at the relevant PEEP value (static strain =VPEEP/FRC). The pressure-volume curve
        generated by the intratracheal pressure sensor at each PEEP level was evaluated using the
        SpiroDynamics application. A dynamic compliance curve was generated during the analysis, and
        volume changes in this curve were determined at each PEEP level. The difference in EELV at
        two different PEEP levels during a descending PEEP trial was calculated as ∆EELV, and the
        difference between ∆EELV and the volume derived from the pressure-volume curve was calculated
        as "volume gain" (gain = ∆EELV - volume derived from the curve). The estimated lung volume
        recovered was calculated using the formula ∆EELV - (∆PEEP x Compliance PEEPlow) and compared
        with the volume gain. The efficiency of the volume gains concept as an indicator of the
        volume gained by alveolar recruitment and its role in personalized PEEP titration was
        evaluated.
  allocation: N/A
  intervention model: Single Group Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Does volume gain indicate recruited lung volume?
  time frame: Patients were ventilated for 10 minutes at each PEEP level.Measurement was taken after 10 minutes.]
  description: A dynamic compliance curve was generated during the analysis, and volume changes in this curve were determined at each PEEP level. The difference in EELV at two different PEEP levels during a descending PEEP trial was calculated as ∆EELV, and the difference between ∆EELV and the volume derived from the pressure-volume curve was calculated as "volume gain" (gain = ∆EELV - volume derived from the curve). The estimated lung volume recovered was calculated using the formula ∆EELV - (∆PEEP x Compliance PEEPlow) and compared with the volume gain.
  measure: Static compliance correlation with volume gain.
  time frame: Patients were ventilated for 10 minutes at each PEEP level.Measurement was taken after 10 minutes.
  description: After measuring the volume gain, its correlation with static compliance was examined. The measurement time at each PEEP level was chosen as 10 minutes. At the end of the measurement, static compliance was measured by applying an end-inspiratory pause
  measure: Calculation of respiratory system elastance and its correlation with volume gain.
  time frame: Patients were ventilated for 10 minutes at each PEEP level.Measurement was taken after 10 minutes.
  description: Respiratory system elastance was calculated using the equation (respiratory system elastance = driving pressure/tidal volume).
  measure: Examination of the relationship between static strain and volume gain.
  time frame: Patients were ventilated for 10 minutes at each PEEP level.Measurement was taken after 10 minutes.
  description: Static strain; calculated by the ratio of tidal volume to FRC at the relevant PEEP level.
  measure: Investigation of the correlation between driving pressure and volume gain
  time frame: Patients were ventilated for 10 minutes at each PEEP level.Measurement was taken after 10 minutes.
  description: During the measurements, volume gain and driving pressure at different PEEP levels were recorded and their correlations were examined.
  measure: Hemodynamic parameters of patient with ARDS were measured during different PEEP measurement.
  time frame: Measurements were taken after 10 minutes of ventilating at the PEEP level.
  description: Systolic blood pressure, diastolic blood pressure and heart rate, peripheral oxygen saturation at different PEEP levels were recorded.
  measure: Arterial blood gas analysis
  time frame: Measurements were taken after 10 minutes of ventilating at the PEEP level.
  description: At all PEEP levels, pH, PaO2 (mmHg), PaCO2 (mmHg), SaO2 (%) were measured in arterial blood gas.
  arm group label: ARDS patient
  arm group type: Other
  description: 14 patients with ARDS were included in the study. It was planned as a single group.
  intervention type: Other
  intervention name: No drugs or biologial agents were used in our trial
  description: Before the measurement, a recruitment maneuver was performed for 30-40 s at a PEEP level of 20 cmH2O. At four different PEEP levels of 15, 10, 5, and 0 cmH2O, a decreasing PEEP trial was performed, and the measurement results were recorded.The measurement time at each PEEP level was chosen as 10 minutes. At the end of the measurement, static compliance was measured by applying an end-inspiratory pause. Respiratory system elastance,static strain volume gain was calculated.The estimated lung volume recovered was calculated using the formula ∆EELV - (∆PEEP x Compliance PEEPlow) and compared with the volume gain.
  arm group label: ARDS patient
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  facility: 
  country: Turkey
  responsible party type: Principal Investigator
  investigator affiliation: Pamukkale University
  investigator full name: Selvinaz Yüksel Tanrıverdi
  investigator title: Specialist, Department of Anesthesiology and Reanimation, MD
  sharing ipd: No