<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/NCT04475068</url>
  </required_header>
  <id_info>
    <org_study_id>HNEdgardoRebagliatiMartins</org_study_id>
    <nct_id>NCT04475068</nct_id>
  </id_info>
  <brief_title>Postural Recruitment Maneuver in Patients With Acute Respiratory Distress Syndrome Due to COVID-19 Infection</brief_title>
  <official_title>Feasibility and Physiological Effects of a Postural Recruitment Maneuver in Patients With Acute Respiratory Distress Syndrome Due to COVID-19 Infection</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hospital Nacional Edgardo Rebagliati Martins</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Universidad de Piura</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Hospital Nacional Edgardo Rebagliati Martins</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>
      The purpose of this study is to evaluate if a postural recruitment maneuver (PRM) improves&#xD;
      the aeration and distribution of lung ventilation in patients with Acute Respiratory Distress&#xD;
      Syndrome (ARDS) caused by COVID-19 infection; without the need to reach high airway pressures&#xD;
      as in the standard lung recruitment maneuver and / or place the patient in prone position.&#xD;
      This strategy could be particularly useful in the context of a major health emergency in&#xD;
      centers with limited resources.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The PRM is based on the known effect of gravity on transpulmonary pressure (PL). Two&#xD;
      principles explain its mechanism of action: 1) the first indicates that atelectasis and&#xD;
      poorly ventilated areas of the lung can improve their aeration by putting the lung in the&#xD;
      highest position. Opposite lateral decubitus causes that upper lung to have a higher PL and&#xD;
      allow a recruiting effect at moderate airway pressures. 2) The second principle is based on&#xD;
      Laplace's Law and postulates that once the upper lung is recruited, it remains without lung&#xD;
      collapse if a sufficient level of positive end-expiratory pressure (PEEP) is applied. Based&#xD;
      on these two precepts, PRM consists of sequentially moving the patient from the supine to the&#xD;
      left lateral decubitus to recover the aeration of the right lung. After that, the patient is&#xD;
      placed in the right lateral position to recruit the left lung; keeping the right lung without&#xD;
      collapse by continuous use of PEEP. Finally, the patient returns to the supine position&#xD;
      looking for an improvement in the distribution of ventilation and global pulmonary aeration,&#xD;
      with a subsequent improvement in gas exchange and pulmonary mechanics.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 17, 2020</start_date>
  <completion_date type="Actual">October 31, 2020</completion_date>
  <primary_completion_date type="Actual">September 30, 2020</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Effects of a postural recruitment maneuver in lung aeration</measure>
    <time_frame>Through study completion (up to 24 hours)</time_frame>
    <description>Lung aeration measured by ultrasound reaeration score, ranges from 0 (all regions are well aerated) to 36 (all regions are consolidated).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Effects of a postural recruitment maneuver in distribution of ventilation</measure>
    <time_frame>Through study completion (up to 24 hours)</time_frame>
    <description>Distribution of ventilation measured by EIT (distribution and changes in the impedance in AU, arbitray units)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Effects of a postural recruitment maneuver in gas exchange</measure>
    <time_frame>Through study completion (up to 24 hours)</time_frame>
    <description>Gas exchange measured by blood gas analysis (PaO2, PaCO2, in mmHg) and capnography (end-tidal CO2, in mmHg)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Effects of a postural recruitment maneuver in respiratory mechanics</measure>
    <time_frame>Through study completion (up to 24 hours)</time_frame>
    <description>Respiratory mechanics measured by esophageal balloon (esophageal pressure, transpulmonary pressure, in cmH2O)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Effects of a postural recruitment maneuver in hemodynamic</measure>
    <time_frame>Through study completion (up to 24 hours)</time_frame>
    <description>Hemodynamic data measured by invasive arterial monitoring (mean arterial pressure, in mmHg)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Feasibility of a postural recruitment maneuver</measure>
    <time_frame>Through study completion (up to 24 hours)</time_frame>
    <description>Oxigenatory tolerance evaluated with pulse oximeter (arterial oxygen saturation, in percentage)</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">15</enrollment>
  <condition>Sars-CoV2</condition>
  <condition>ARDS</condition>
  <arm_group>
    <arm_group_label>Moderate to severe ARDS patients due to COVID-19 infection</arm_group_label>
    <description>Mechanically ventilated patients with moderate to severe ARDS due to COVID-19 infection admitted to the COVID Intensive Care Unit of Rebagliati Hospital.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Lateral Position (left and right lateral decubitus)</intervention_name>
    <description>Prior to initiating the protocol, patients will be sedated deeply with sedatives and opioids and paralyzed. Patients will be evaluated in 5 positions sequentially: 1) Supine 2) Left lateral 3) Supine 4) Right lateral 5) Supine. The side with the least ventilation evaluated by EIT will define which side will start the sequence. Each step will last 30 minutes. Aeration measured by Electric Impedance Tomography (EIT) and lung ultrasound, distribution of the lung ventilation and perfusion measured by EIT, ventilator and hemodynamic parameters, esophageal pressure, and blood gas analysis will be recorded at the end of each step. Continuous monitoring of blood pressure, heart rate and saturation of arterial blood (SpO2) will be carried out during all steps of the protocol to assess the tolerance to the procedure.</description>
    <arm_group_label>Moderate to severe ARDS patients due to COVID-19 infection</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        This physiological study will enroll 12 adult ARDS patients admitted to the COVID Intensive&#xD;
        Care Unit of Rebagliati Hospital. Informed consent will be obtained from the patient or&#xD;
        legally authorized substitute decision maker.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients &gt; 18 years of age&#xD;
&#xD;
          -  Patients with moderate-to-severe ARDS as per the Berlin definition&#xD;
&#xD;
          -  Infection due to COVID-19&#xD;
&#xD;
          -  Body mass index (BMI) ≤ 35 kg /m^2.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Contraindication for EIT monitoring&#xD;
&#xD;
               1. Unstable spine or pelvic fractures&#xD;
&#xD;
               2. Pacemaker, automatic implantable cardioverter defibrillator&#xD;
&#xD;
               3. Skin lesions between the 4th and 5th ribs where the EIT belt is worn&#xD;
&#xD;
          -  Pregnancy&#xD;
&#xD;
          -  Major hemodynamic instability::&#xD;
&#xD;
               1. Mean arterial pressure lower than 60 mm Hg despite adequate fluid resuscitation&#xD;
                  and use of vasopressors.&#xD;
&#xD;
               2. FC&gt; 120 or &lt;60 per minute&#xD;
&#xD;
               3. Presence of uncontrolled arrhythmias.&#xD;
&#xD;
          -  More than 1 week of mechanical ventilation&#xD;
&#xD;
          -  Failure of more than 2 extrapulmonary organs.&#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_official>
    <last_name>Rollin Roldán, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Hospital Nacional Edgardo Rebagliati Martins</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Hospital Rebagliati</name>
      <address>
        <city>Jesús María</city>
        <state>Lima</state>
        <zip>Lima 11</zip>
        <country>Peru</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Peru</country>
  </location_countries>
  <verification_date>August 2021</verification_date>
  <study_first_submitted>July 14, 2020</study_first_submitted>
  <study_first_submitted_qc>July 15, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 17, 2020</study_first_posted>
  <last_update_submitted>August 23, 2021</last_update_submitted>
  <last_update_submitted_qc>August 23, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">August 25, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Hospital Nacional Edgardo Rebagliati Martins</investigator_affiliation>
    <investigator_full_name>Rollin Roldán</investigator_full_name>
    <investigator_title>Principal investigator</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Respiratory Distress Syndrome</mesh_term>
    <mesh_term>Respiratory Distress Syndrome, Newborn</mesh_term>
    <mesh_term>Acute Lung Injury</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/NCT04475068
org study id: HNEdgardoRebagliatiMartins
nct id: NCT04475068
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The purpose of this study is to evaluate if a postural recruitment maneuver (PRM) improves
      the aeration and distribution of lung ventilation in patients with Acute Respiratory Distress
      Syndrome (ARDS) caused by COVID-19 infection; without the need to reach high airway pressures
      as in the standard lung recruitment maneuver and / or place the patient in prone position.
      This strategy could be particularly useful in the context of a major health emergency in
      centers with limited resources.
The PRM is based on the known effect of gravity on transpulmonary pressure (PL). Two
      principles explain its mechanism of action: 1) the first indicates that atelectasis and
      poorly ventilated areas of the lung can improve their aeration by putting the lung in the
      highest position. Opposite lateral decubitus causes that upper lung to have a higher PL and
      allow a recruiting effect at moderate airway pressures. 2) The second principle is based on
      Laplace's Law and postulates that once the upper lung is recruited, it remains without lung
      collapse if a sufficient level of positive end-expiratory pressure (PEEP) is applied. Based
      on these two precepts, PRM consists of sequentially moving the patient from the supine to the
      left lateral decubitus to recover the aeration of the right lung. After that, the patient is
      placed in the right lateral position to recruit the left lung; keeping the right lung without
      collapse by continuous use of PEEP. Finally, the patient returns to the supine position
      looking for an improvement in the distribution of ventilation and global pulmonary aeration,
      with a subsequent improvement in gas exchange and pulmonary mechanics.
observational model: Cohort
time perspective: Prospective
measure: Effects of a postural recruitment maneuver in lung aeration
time frame: Through study completion (up to 24 hours)
description: Lung aeration measured by ultrasound reaeration score, ranges from 0 (all regions are well aerated) to 36 (all regions are consolidated).
measure: Effects of a postural recruitment maneuver in distribution of ventilation
time frame: Through study completion (up to 24 hours)
description: Distribution of ventilation measured by EIT (distribution and changes in the impedance in AU, arbitray units)
measure: Effects of a postural recruitment maneuver in gas exchange
time frame: Through study completion (up to 24 hours)
description: Gas exchange measured by blood gas analysis (PaO2, PaCO2, in mmHg) and capnography (end-tidal CO2, in mmHg)
measure: Effects of a postural recruitment maneuver in respiratory mechanics
time frame: Through study completion (up to 24 hours)
description: Respiratory mechanics measured by esophageal balloon (esophageal pressure, transpulmonary pressure, in cmH2O)
measure: Effects of a postural recruitment maneuver in hemodynamic
time frame: Through study completion (up to 24 hours)
description: Hemodynamic data measured by invasive arterial monitoring (mean arterial pressure, in mmHg)
measure: Feasibility of a postural recruitment maneuver
time frame: Through study completion (up to 24 hours)
description: Oxigenatory tolerance evaluated with pulse oximeter (arterial oxygen saturation, in percentage)
arm group label: Moderate to severe ARDS patients due to COVID-19 infection
description: Mechanically ventilated patients with moderate to severe ARDS due to COVID-19 infection admitted to the COVID Intensive Care Unit of Rebagliati Hospital.
intervention type: Procedure
intervention name: Lateral Position (left and right lateral decubitus)
description: Prior to initiating the protocol, patients will be sedated deeply with sedatives and opioids and paralyzed. Patients will be evaluated in 5 positions sequentially: 1) Supine 2) Left lateral 3) Supine 4) Right lateral 5) Supine. The side with the least ventilation evaluated by EIT will define which side will start the sequence. Each step will last 30 minutes. Aeration measured by Electric Impedance Tomography (EIT) and lung ultrasound, distribution of the lung ventilation and perfusion measured by EIT, ventilator and hemodynamic parameters, esophageal pressure, and blood gas analysis will be recorded at the end of each step. Continuous monitoring of blood pressure, heart rate and saturation of arterial blood (SpO2) will be carried out during all steps of the protocol to assess the tolerance to the procedure.
arm group label: Moderate to severe ARDS patients due to COVID-19 infection
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Rollin Roldán, MD
role: Principal Investigator
affiliation: Hospital Nacional Edgardo Rebagliati Martins
facility: 
country: Peru
responsible party type: Principal Investigator
investigator affiliation: Hospital Nacional Edgardo Rebagliati Martins
investigator full name: Rollin Roldán
investigator title: Principal investigator
mesh term: Respiratory Distress Syndrome
mesh term: Respiratory Distress Syndrome, Newborn
mesh term: Acute Lung Injury
sharing ipd: No