<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/NCT03753022</url>
  </required_header>
  <id_info>
    <org_study_id>89704818.6.0000.5505</org_study_id>
    <nct_id>NCT03753022</nct_id>
  </id_info>
  <brief_title>Effects of PEEP on Parameters of Tissue Perfusion in Patients Post Cardiac Surgery</brief_title>
  <official_title>Effects of PEEP on Parameters of Tissue Perfusion and Clinical Outcomes After Coronary Artery Bypass Graft Surgery - a Randomized Clinical Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Federal University of São Paulo</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Vanessa Marques Ferreira</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Federal University of São Paulo</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>
      Pulmonary dysfunction is a condition inherent in cardiac surgery because of various&#xD;
      interventions, such as general anesthesia, a median sternotomy, cardiopulmonary bypass and&#xD;
      establishment of internal thoracic artery dissection.&#xD;
&#xD;
      In situations when there is a deterioration in oxygenation, increased positive pressure on&#xD;
      the airways end pressure (PEEP) can be used as therapeutic mode by reversing severe hypoxemia&#xD;
      resulting pulmonary shunt. But the use of PEEP has been associated to reduced cardiac output,&#xD;
      due mainly to decrease systemic venous return consequent to increased intrathoracic pressure,&#xD;
      and thus might reduce tissue oxygenation. Moreover, the increased transpulmonary gradient may&#xD;
      also impair right ventricular ejection exacerbating the hemodynamic consequences in some&#xD;
      patients, which in clinical practice this diagnosis may be difficult to perform.&#xD;
&#xD;
      In hypovolemic patients or those with cardiac changes may become even more pronounced,&#xD;
      resulting in accentuation of low flow and systemic hypotension entailing changes in markers&#xD;
      of tissue perfusion commonly measured by venous saturation central difference venoarterial&#xD;
      carbon dioxide and lactate. The hypothesis of the investigators is that PEEP of 10 cmH2O and&#xD;
      15 cmH2O can be applied to reverse lung damage in patients in the immediate postoperative&#xD;
      myocardial revascularization without repercussion tissue importantly in markers of tissue&#xD;
      perfusion.&#xD;
&#xD;
      The objective is to evaluate the effects of different optimization levels of PEEP on gas&#xD;
      exchange and influences the tissue perfusion after coronary artery bypass graft surgery.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a prospective, randomized study and will be performed on patients who accept coronary&#xD;
      artery bypass grafting with cardiopulmonary bypass, the conscious openness to participate in&#xD;
      the study. Age, sex, body mass index (BMI), smoking habits, diagnosis, additional diseases,&#xD;
      drugs used, surgery, intervention, peroperative supportive treatments, left ventricular&#xD;
      ejection fraction, post operative blood and cardiopulmonary bypass (CPB) time (min), cross&#xD;
      clamp time (min), duration of operation, postoperative extubation period, intensive care day&#xD;
      of hospitalization, day of hospitalization will be recorded.The study was planned in 3&#xD;
      groups. Group G5 (control group: no changes will be made to the value of PEEP). Group G10&#xD;
      [after 30 minutes of admission (time 0) the PEEP will be raised to 10 cmH2O (time1) for 30&#xD;
      minutes and then returned to 5 cmH2O (time 2)]. Group G15 [after 30 minutes of admission&#xD;
      (time 0) the PEEP will be raised to 15 cmH2O (time 1) for 30 minutes and then returned to 5&#xD;
      cm H2O (time 2)]. At each time of protocol (0, 1 and 2) will be collected: arterial blood gas&#xD;
      measurements (partial pressure of arterial oxygen [PaO2] and partial pressure of carbon&#xD;
      dioxide ([PaCO2]), the ratio between the partial oxygen pressure, inspired oxygen fraction&#xD;
      (PaO2/FiO2) and pH. Also, will be performed parameters of tissue perfusion: central venous&#xD;
      oxygen saturation ([SVO2]), arterial blood lactate, venoarterial CO2 difference ([Dif VA&#xD;
      CO2]) and vital signs. In all other respects, treatment will follow the standard of care.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date type="Actual">January 2012</start_date>
  <completion_date type="Anticipated">December 2019</completion_date>
  <primary_completion_date type="Anticipated">December 2019</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>Sequential Assignment</intervention_model>
    <intervention_model_description>The study was planned in 3 groups. Group G5 (control group: no changes will be made to the value of PEEP). Group G10 [after 30 minutes of admission (time 0) the PEEP will be raised to 10 cmH2O (time1) for 30 minutes and then returned to 5 cm H2O (time 2)]. Group G15 [after 30 minutes of admission (time 0) the PEEP will be raised to 15 cmH2O (time 1) for 30 minutes and then returned to 5 cm H2O (time 2)].</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Triple (Participant, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Pulmonary events</measure>
    <time_frame>Through study completion, an average of 24 hours after surgery</time_frame>
    <description>Pleural effusion was considered relevant when exceeding the phrenicocostal angle and fluid drainage was monitored hourly. Atelectasis was acknowledged when a clear atelectasis radiologic shadow exceeded 15 mm in width, with linear atelectasis</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Arterial oxygenation</measure>
    <time_frame>Immediately after arrival at the intensive care unit until the end of protocol (around 5 hours)</time_frame>
    <description>arterial blood gas measurements (partial pressure of arterial oxygen [PaO2]</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Tissue oxygenation</measure>
    <time_frame>Immediately after arrival at the intensive care unit until the end of protocol (around 5 hours)</time_frame>
    <description>(central venous oxygen saturation , arterial blood lactate and venoarterial CO2 difference</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Length of intensive care unit (ICU) stay</measure>
    <time_frame>From the day of surgery up to ICU discharge, maximum censoring at day 28 after surgery ]</time_frame>
    <description>Days since surgery until ICU discharge</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Length of Hospital Stay</measure>
    <time_frame>From the day of surgery up to Hospital discharge, maximum censoring at day 28 after surgery ]</time_frame>
    <description>Days since surgery until Hospital discharge</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Duration of mechanical ventilation</measure>
    <time_frame>Through study completion, an average of 24 hours after surgery</time_frame>
    <description>Hours since surgery until extubation</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">125</enrollment>
  <condition>Coronary Artery Disease</condition>
  <condition>Coronary Artery Bypass Grafting</condition>
  <condition>Acute Lung Injury</condition>
  <arm_group>
    <arm_group_label>Group G5</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
    <description>Patients submitted to CABG and peep 5</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group G10</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients submitted to CABG and peep 10</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group G15</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients submitted to CABG and peep 15</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Group G5</intervention_name>
    <description>Submitted to peep 5</description>
    <arm_group_label>Group G5</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Group G10</intervention_name>
    <description>Submitted to peep 10</description>
    <arm_group_label>Group G10</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Group G15</intervention_name>
    <description>Submitted to peep 15</description>
    <arm_group_label>Group G15</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  elective and isolated CABG, ejection fraction greater than 40%&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  patients with a diagnosis of pulmonary disease, emergency surgery and mechanical&#xD;
             ventilation prior to surgery.&#xD;
&#xD;
        Postoperative patients who had radiological abnormalities suggestive of pneumothorax,&#xD;
        atrial or ventricular arrhythmias, electrical ischemic changes on ECG, pulse pressure&#xD;
        variation of more than 13, hemodynamic instability characterized by mean arterial pressure&#xD;
        less than 60 mmHg, nor epinephrine greater than 0.5 mcg/Kg/ min and the presence of&#xD;
        increased bleeding through the drains (greater than 2 ml \ kg \ h) the protocol was&#xD;
        discontinued and the patient excluded from the study.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <verification_date>November 2018</verification_date>
  <study_first_submitted>November 21, 2018</study_first_submitted>
  <study_first_submitted_qc>November 21, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 26, 2018</study_first_posted>
  <last_update_submitted>November 27, 2018</last_update_submitted>
  <last_update_submitted_qc>November 27, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">November 29, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Federal University of São Paulo</investigator_affiliation>
    <investigator_full_name>Solange Guizilini</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>Acute Lung Injury</keyword>
  <keyword>postoperative of cardiac surgery</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lung Injury</mesh_term>
    <mesh_term>Acute Lung Injury</mesh_term>
    <mesh_term>Coronary Artery Disease</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/NCT03753022
org study id: 89704818.6.0000.5505
nct id: NCT03753022
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Pulmonary dysfunction is a condition inherent in cardiac surgery because of various
      interventions, such as general anesthesia, a median sternotomy, cardiopulmonary bypass and
      establishment of internal thoracic artery dissection.

      In situations when there is a deterioration in oxygenation, increased positive pressure on
      the airways end pressure (PEEP) can be used as therapeutic mode by reversing severe hypoxemia
      resulting pulmonary shunt. But the use of PEEP has been associated to reduced cardiac output,
      due mainly to decrease systemic venous return consequent to increased intrathoracic pressure,
      and thus might reduce tissue oxygenation. Moreover, the increased transpulmonary gradient may
      also impair right ventricular ejection exacerbating the hemodynamic consequences in some
      patients, which in clinical practice this diagnosis may be difficult to perform.

      In hypovolemic patients or those with cardiac changes may become even more pronounced,
      resulting in accentuation of low flow and systemic hypotension entailing changes in markers
      of tissue perfusion commonly measured by venous saturation central difference venoarterial
      carbon dioxide and lactate. The hypothesis of the investigators is that PEEP of 10 cmH2O and
      15 cmH2O can be applied to reverse lung damage in patients in the immediate postoperative
      myocardial revascularization without repercussion tissue importantly in markers of tissue
      perfusion.

      The objective is to evaluate the effects of different optimization levels of PEEP on gas
      exchange and influences the tissue perfusion after coronary artery bypass graft surgery.
This is a prospective, randomized study and will be performed on patients who accept coronary
      artery bypass grafting with cardiopulmonary bypass, the conscious openness to participate in
      the study. Age, sex, body mass index (BMI), smoking habits, diagnosis, additional diseases,
      drugs used, surgery, intervention, peroperative supportive treatments, left ventricular
      ejection fraction, post operative blood and cardiopulmonary bypass (CPB) time (min), cross
      clamp time (min), duration of operation, postoperative extubation period, intensive care day
      of hospitalization, day of hospitalization will be recorded.The study was planned in 3
      groups. Group G5 (control group: no changes will be made to the value of PEEP). Group G10
      [after 30 minutes of admission (time 0) the PEEP will be raised to 10 cmH2O (time1) for 30
      minutes and then returned to 5 cmH2O (time 2)]. Group G15 [after 30 minutes of admission
      (time 0) the PEEP will be raised to 15 cmH2O (time 1) for 30 minutes and then returned to 5
      cm H2O (time 2)]. At each time of protocol (0, 1 and 2) will be collected: arterial blood gas
      measurements (partial pressure of arterial oxygen [PaO2] and partial pressure of carbon
      dioxide ([PaCO2]), the ratio between the partial oxygen pressure, inspired oxygen fraction
      (PaO2/FiO2) and pH. Also, will be performed parameters of tissue perfusion: central venous
      oxygen saturation ([SVO2]), arterial blood lactate, venoarterial CO2 difference ([Dif VA
      CO2]) and vital signs. In all other respects, treatment will follow the standard of care.
allocation: Randomized
intervention model: Sequential Assignment
intervention model description: The study was planned in 3 groups. Group G5 (control group: no changes will be made to the value of PEEP). Group G10 [after 30 minutes of admission (time 0) the PEEP will be raised to 10 cmH2O (time1) for 30 minutes and then returned to 5 cm H2O (time 2)]. Group G15 [after 30 minutes of admission (time 0) the PEEP will be raised to 15 cmH2O (time 1) for 30 minutes and then returned to 5 cm H2O (time 2)].
primary purpose: Treatment
masking: Triple (Participant, Investigator, Outcomes Assessor)
measure: Pulmonary events
time frame: Through study completion, an average of 24 hours after surgery
description: Pleural effusion was considered relevant when exceeding the phrenicocostal angle and fluid drainage was monitored hourly. Atelectasis was acknowledged when a clear atelectasis radiologic shadow exceeded 15 mm in width, with linear atelectasis
measure: Arterial oxygenation
time frame: Immediately after arrival at the intensive care unit until the end of protocol (around 5 hours)
description: arterial blood gas measurements (partial pressure of arterial oxygen [PaO2]
measure: Tissue oxygenation
time frame: Immediately after arrival at the intensive care unit until the end of protocol (around 5 hours)
description: (central venous oxygen saturation , arterial blood lactate and venoarterial CO2 difference
measure: Length of intensive care unit (ICU) stay
time frame: From the day of surgery up to ICU discharge, maximum censoring at day 28 after surgery ]
description: Days since surgery until ICU discharge
measure: Length of Hospital Stay
time frame: From the day of surgery up to Hospital discharge, maximum censoring at day 28 after surgery ]
description: Days since surgery until Hospital discharge
measure: Duration of mechanical ventilation
time frame: Through study completion, an average of 24 hours after surgery
description: Hours since surgery until extubation
arm group label: Group G5
arm group type: Sham Comparator
description: Patients submitted to CABG and peep 5
arm group label: Group G10
arm group type: Experimental
description: Patients submitted to CABG and peep 10
arm group label: Group G15
arm group type: Experimental
description: Patients submitted to CABG and peep 15
intervention type: Other
intervention name: Group G5
description: Submitted to peep 5
arm group label: Group G5
intervention type: Other
intervention name: Group G10
description: Submitted to peep 10
arm group label: Group G10
intervention type: Other
intervention name: Group G15
description: Submitted to peep 15
arm group label: Group G15
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
responsible party type: Principal Investigator
investigator affiliation: Federal University of São Paulo
investigator full name: Solange Guizilini
investigator title: Principal Investigator
mesh term: Lung Injury
mesh term: Acute Lung Injury
mesh term: Coronary Artery Disease
sharing ipd: Undecided