<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/NCT04470258</url>
  </required_header>
  <id_info>
    <org_study_id>4.104.233</org_study_id>
    <nct_id>NCT04470258</nct_id>
  </id_info>
  <brief_title>Elmo Respiratory Support Project - COVID-19</brief_title>
  <official_title>Elmo Respiratory Support Project for Patients With Hypoxemic Respiratory Insufficiency in Covid-19: Proof Of Concept and Usability</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Escola de Saúde Pública do Ceará</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Escola de Saúde Pública do Ceará</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 number of COVID-19 cases has been growing exponentially, so that the industrialized&#xD;
      economies are facing a significant shortage in the number of ventilators available to meet&#xD;
      the demands imposed by the disease. Noninvasive ventilatory support can be valuable for&#xD;
      certain patients, avoiding tracheal intubation and its complications. However, non-invasive&#xD;
      techniques have a high potential to generate aerosols during their implementation, especially&#xD;
      when masks are used in which it is virtually impossible to completely prevent air leakage and&#xD;
      the dispersion of aerosols with viral particles. In this context, a helmet-like interface&#xD;
      system with complete sealing and respiratory isolation of the patient's head can allow the&#xD;
      application of ventilatory support without intubation and with safety and comfort for&#xD;
      healthcare professionals and patients. This type of device is not accessible in Brazil, nor&#xD;
      is it available for immediate import, requiring the development of a national product.&#xD;
      Meanwhile, a task force under the coordination of the School of Public Health (ESP) and&#xD;
      Fundação Cearense de Apoio à Pesquisa (FUNCAP), with support from SENAI / FIEC and the&#xD;
      Federal Universities of Ceará (UFC) and the University of Fortaleza (UNIFOR) advanced in the&#xD;
      development of a prototype and accessory system capable of providing airway pressurization&#xD;
      through a helmet-type interface, which was called the Elmo System.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Objectives: 1. Validate the functionalities to fulfill the requirements and evaluate the&#xD;
      usability of the Elmo System and 2. Evaluate the effectiveness of the Elmo system in the&#xD;
      treatment of support to patients with hypoxemic respiratory failure caused by COVID-19.&#xD;
&#xD;
      Methods: This is a study divided into two stages. For objective 1, tests will be carried out&#xD;
      on healthy volunteers using prototypes of the Elmo system and assessing whether their&#xD;
      effectiveness in providing positive airway pressure and their usability from the perspective&#xD;
      of their primary users (doctor, physiotherapist and nurses) and the comfort of the volunteer.&#xD;
      After the tests to meet the requirements: continuous positive airway pressure (CPAP) offer,&#xD;
      guarantee of the maintenance of alveolar ventilation without carbon dioxide (CO2)&#xD;
      rebreathing, monitoring of intra-ELMO pressure, minimization of the adverse effects of the&#xD;
      system such as noise, face temperature, dryness of the airways and overall comfort . In&#xD;
      addition, realistic simulations will be carried out, centered on the assessment based on&#xD;
      heuristic principles by a multiprofessional team with experience in mechanical ventilation,&#xD;
      to assess the performance of the new equipment in the execution of the pre-defined skills.&#xD;
      The second phase will consist of a clinical trial with application of the Elmo System to 10&#xD;
      patients with hypoxemic respiratory failure by COVID-19, to evaluate its effectiveness,&#xD;
      through the analysis of physiological variables and patient comfort, as well as their&#xD;
      clinical outcomes (need for tracheal intubation) and Insuf recovery time. Resp. Hypoxemic and&#xD;
      need for O2 in a referral hospital for the treatment of this condition in Fortaleza / Ceara.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 25, 2020</start_date>
  <completion_date type="Actual">November 30, 2020</completion_date>
  <primary_completion_date type="Actual">August 30, 2020</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Device Feasibility</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Usability tests of the Elmo system using Euristic usability principles</measure>
    <time_frame>One week after all tests</time_frame>
    <description>Usability test with the description of the identified problems of the main basic skills necessary for the correct handling of the non-invasive respiratory device (ELMO), through realistic simulations, severity scale and usability.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Evaluation of the effectiveness of the ELMO system using physiological parameters</measure>
    <time_frame>One week after all tests</time_frame>
    <description>To evaluate the effectiveness of the Elmo system in the supportive treatment of patients with hypoxemic respiratory failure caused by COVID-19 through peripheral oxygen saturation (%) before, during and after the application of Elmo.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Evaluation of the effectiveness of the ELMO system using physiological parameters</measure>
    <time_frame>One week after all tests</time_frame>
    <description>To evaluate the effectiveness of the Elmo system in the supportive treatment of patients with hypoxemic respiratory failure caused by COVID-19 through respiratory rate (irpm) before, during and after the application of Elmo.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evaluation of the effectiveness of the ELMO system using physiological parameters</measure>
    <time_frame>One week after all tests</time_frame>
    <description>To evaluate the effectiveness of the Elmo system in the supportive treatment of patients with hypoxemic respiratory failure caused by COVID-19 through heart rate before, during and after the application of Elmo.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evaluation of the effectiveness of the ELMO system using physiological parameters</measure>
    <time_frame>One week after all tests</time_frame>
    <description>To evaluate the effectiveness of the Elmo system in the supportive treatment of patients with hypoxemic respiratory failure caused by COVID-19 through blood pressure before, during and after the application of Elmo.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evaluation of the effectiveness of the ELMO system using physiological parameters</measure>
    <time_frame>One week after all tests</time_frame>
    <description>To evaluate the effectiveness of the Elmo system in the supportive treatment of patients with hypoxemic respiratory failure caused by COVID-19 through CO2 measurement at the end of exhalation (mmHg) before, during and after the application of Elmo.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">10</enrollment>
  <condition>COVID-19</condition>
  <condition>Respiratory Failure With Hypoxia</condition>
  <arm_group>
    <arm_group_label>ELMO PROJECT AT COVID-19: PROOF OF CONCEPT AND USABILITY</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>A realistic simulation will be carried out, centered on the heuristic evaluation, by a multiprofessional team (N= 6), to evaluate the performance of the new equipment in the execution of the pre-defined skills. The prototype will be tested on a mannequin by the research team and on healthy volunteers by health professionals, where physiological parameters and interface comfort will be evaluated.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>ELMO PROJECT AT COVID-19: STUDY IN HUMANS</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>The second phase will consist of a clinical trial, in the application of the non-invasive respiratory device in 10 patients with respiratory failure by COVID-19, to assess its clinical effectiveness, through the analysis of the physiological variables and patient comfort.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>ELMO PROJECT AT COVID-19: STUDY IN HUMANS</intervention_name>
    <description>The Elmo system will be applied to 10 patients with hypoxemic respiratory failure by COVID-19 and its effectiveness will be assessed by analyzing the physiological variables and the patient's comfort, as well as their clinical outcomes (need for tracheal intubation) and recovery time. Hypoxemic respiratory failure and need for O2.</description>
    <arm_group_label>ELMO PROJECT AT COVID-19: STUDY IN HUMANS</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>ELMO PROJECT AT COVID-19: PROOF OF CONCEPT AND USABILITY</intervention_name>
    <description>After testing for the following requirements: offering CPAP, ensuring the maintenance of alveolar ventilation without CO2 rebreathing, monitoring intra-ELMO pressure, minimizing adverse effects of the system such as noise, face temperature, airway dryness and comfort global; tests will be carried out on healthy volunteers using prototypes of the Elmo system and assessing whether their effectiveness in providing positive airway pressure and their usability from the perspective of their primary users (doctor, physiotherapist and nurses) and the volunteer's comfort . With this, realistic simulations will be carried out, centered on the evaluation based on heuristic principles.</description>
    <arm_group_label>ELMO PROJECT AT COVID-19: PROOF OF CONCEPT AND USABILITY</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adult patient, age&gt; or = 18 years, both sexes;&#xD;
&#xD;
          -  Patient should be alert, oriented, and cooperative;&#xD;
&#xD;
          -  When using oxygen therapy by CNO2&gt; or = 4L/min, MR&gt; or = 8 L/min of O2 or MV 50%, for&#xD;
             maintain SpO2&gt; 92%;&#xD;
&#xD;
          -  Gasometric parameters (pre ELMO, up to 30 min before): pH&gt; 7.35, PaO2&gt; 60 mmHg;&#xD;
&#xD;
          -  RX or chest CT scan with bilateral parenchymal opacities from the last 24 hours.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Exacerbation of Asthma, Chronic Obstructive Pulmonary Disease (COPD), pulmonary&#xD;
             fibrosis or other lung diseases;&#xD;
&#xD;
          -  Hemodynamic instability (SBP &lt;90 mmHg or MBP &lt;65 mmHg or need for vasoactive drugs);&#xD;
&#xD;
          -  Pneumothorax or pneumomediastinum;&#xD;
&#xD;
          -  Respiratory acidosis (pH &lt;7.35 with PaCO2 &gt;46mmHg);&#xD;
&#xD;
          -  Signs of respiratory muscle fatigue (paradoxical breathing, accessory muscle use);&#xD;
&#xD;
          -  Nausea or vomiting;&#xD;
&#xD;
          -  Disorders of the auditory canal;&#xD;
&#xD;
          -  Use of nasoenteric or nasogastric feeding tubes;&#xD;
&#xD;
          -  Imminent risk of respiratory arrest.&#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>MARCELO HOLANDA, Doctor</last_name>
    <role>Principal Investigator</role>
    <affiliation>Escola de Saúde Pública do Ceará</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Hospital Leonardo Da Vinci</name>
      <address>
        <city>Fortaleza</city>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Brazil</country>
  </location_countries>
  <verification_date>April 2021</verification_date>
  <study_first_submitted>June 10, 2020</study_first_submitted>
  <study_first_submitted_qc>July 11, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 14, 2020</study_first_posted>
  <last_update_submitted>April 18, 2021</last_update_submitted>
  <last_update_submitted_qc>April 18, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">April 20, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Escola de Saúde Pública do Ceará</investigator_affiliation>
    <investigator_full_name>Marcelo Alcantara Holanda</investigator_full_name>
    <investigator_title>Doctor</investigator_title>
  </responsible_party>
  <keyword>COVID-19</keyword>
  <keyword>Accute breathing failure</keyword>
  <keyword>Continuous Positive Airway Pressure</keyword>
  <keyword>Usability</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>COVID-19</mesh_term>
    <mesh_term>Respiratory Insufficiency</mesh_term>
    <mesh_term>Hypoxia</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/NCT04470258
org study id: 4.104.233
nct id: NCT04470258
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The number of COVID-19 cases has been growing exponentially, so that the industrialized
      economies are facing a significant shortage in the number of ventilators available to meet
      the demands imposed by the disease. Noninvasive ventilatory support can be valuable for
      certain patients, avoiding tracheal intubation and its complications. However, non-invasive
      techniques have a high potential to generate aerosols during their implementation, especially
      when masks are used in which it is virtually impossible to completely prevent air leakage and
      the dispersion of aerosols with viral particles. In this context, a helmet-like interface
      system with complete sealing and respiratory isolation of the patient's head can allow the
      application of ventilatory support without intubation and with safety and comfort for
      healthcare professionals and patients. This type of device is not accessible in Brazil, nor
      is it available for immediate import, requiring the development of a national product.
      Meanwhile, a task force under the coordination of the School of Public Health (ESP) and
      Fundação Cearense de Apoio à Pesquisa (FUNCAP), with support from SENAI / FIEC and the
      Federal Universities of Ceará (UFC) and the University of Fortaleza (UNIFOR) advanced in the
      development of a prototype and accessory system capable of providing airway pressurization
      through a helmet-type interface, which was called the Elmo System.
Objectives: 1. Validate the functionalities to fulfill the requirements and evaluate the
      usability of the Elmo System and 2. Evaluate the effectiveness of the Elmo system in the
      treatment of support to patients with hypoxemic respiratory failure caused by COVID-19.

      Methods: This is a study divided into two stages. For objective 1, tests will be carried out
      on healthy volunteers using prototypes of the Elmo system and assessing whether their
      effectiveness in providing positive airway pressure and their usability from the perspective
      of their primary users (doctor, physiotherapist and nurses) and the comfort of the volunteer.
      After the tests to meet the requirements: continuous positive airway pressure (CPAP) offer,
      guarantee of the maintenance of alveolar ventilation without carbon dioxide (CO2)
      rebreathing, monitoring of intra-ELMO pressure, minimization of the adverse effects of the
      system such as noise, face temperature, dryness of the airways and overall comfort . In
      addition, realistic simulations will be carried out, centered on the assessment based on
      heuristic principles by a multiprofessional team with experience in mechanical ventilation,
      to assess the performance of the new equipment in the execution of the pre-defined skills.
      The second phase will consist of a clinical trial with application of the Elmo System to 10
      patients with hypoxemic respiratory failure by COVID-19, to evaluate its effectiveness,
      through the analysis of physiological variables and patient comfort, as well as their
      clinical outcomes (need for tracheal intubation) and Insuf recovery time. Resp. Hypoxemic and
      need for O2 in a referral hospital for the treatment of this condition in Fortaleza / Ceara.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Device Feasibility
masking: None (Open Label)
measure: Usability tests of the Elmo system using Euristic usability principles
time frame: One week after all tests
description: Usability test with the description of the identified problems of the main basic skills necessary for the correct handling of the non-invasive respiratory device (ELMO), through realistic simulations, severity scale and usability.
measure: Evaluation of the effectiveness of the ELMO system using physiological parameters
time frame: One week after all tests
description: To evaluate the effectiveness of the Elmo system in the supportive treatment of patients with hypoxemic respiratory failure caused by COVID-19 through peripheral oxygen saturation (%) before, during and after the application of Elmo.
measure: Evaluation of the effectiveness of the ELMO system using physiological parameters
time frame: One week after all tests
description: To evaluate the effectiveness of the Elmo system in the supportive treatment of patients with hypoxemic respiratory failure caused by COVID-19 through respiratory rate (irpm) before, during and after the application of Elmo.
measure: Evaluation of the effectiveness of the ELMO system using physiological parameters
time frame: One week after all tests
description: To evaluate the effectiveness of the Elmo system in the supportive treatment of patients with hypoxemic respiratory failure caused by COVID-19 through heart rate before, during and after the application of Elmo.
measure: Evaluation of the effectiveness of the ELMO system using physiological parameters
time frame: One week after all tests
description: To evaluate the effectiveness of the Elmo system in the supportive treatment of patients with hypoxemic respiratory failure caused by COVID-19 through blood pressure before, during and after the application of Elmo.
measure: Evaluation of the effectiveness of the ELMO system using physiological parameters
time frame: One week after all tests
description: To evaluate the effectiveness of the Elmo system in the supportive treatment of patients with hypoxemic respiratory failure caused by COVID-19 through CO2 measurement at the end of exhalation (mmHg) before, during and after the application of Elmo.
arm group label: ELMO PROJECT AT COVID-19: PROOF OF CONCEPT AND USABILITY
arm group type: Other
description: A realistic simulation will be carried out, centered on the heuristic evaluation, by a multiprofessional team (N= 6), to evaluate the performance of the new equipment in the execution of the pre-defined skills. The prototype will be tested on a mannequin by the research team and on healthy volunteers by health professionals, where physiological parameters and interface comfort will be evaluated.
arm group label: ELMO PROJECT AT COVID-19: STUDY IN HUMANS
arm group type: Other
description: The second phase will consist of a clinical trial, in the application of the non-invasive respiratory device in 10 patients with respiratory failure by COVID-19, to assess its clinical effectiveness, through the analysis of the physiological variables and patient comfort.
intervention type: Other
intervention name: ELMO PROJECT AT COVID-19: STUDY IN HUMANS
description: The Elmo system will be applied to 10 patients with hypoxemic respiratory failure by COVID-19 and its effectiveness will be assessed by analyzing the physiological variables and the patient's comfort, as well as their clinical outcomes (need for tracheal intubation) and recovery time. Hypoxemic respiratory failure and need for O2.
arm group label: ELMO PROJECT AT COVID-19: STUDY IN HUMANS
intervention type: Device
intervention name: ELMO PROJECT AT COVID-19: PROOF OF CONCEPT AND USABILITY
description: After testing for the following requirements: offering CPAP, ensuring the maintenance of alveolar ventilation without CO2 rebreathing, monitoring intra-ELMO pressure, minimizing adverse effects of the system such as noise, face temperature, airway dryness and comfort global; tests will be carried out on healthy volunteers using prototypes of the Elmo system and assessing whether their effectiveness in providing positive airway pressure and their usability from the perspective of their primary users (doctor, physiotherapist and nurses) and the volunteer's comfort . With this, realistic simulations will be carried out, centered on the evaluation based on heuristic principles.
arm group label: ELMO PROJECT AT COVID-19: PROOF OF CONCEPT AND USABILITY
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: MARCELO HOLANDA, Doctor
role: Principal Investigator
affiliation: Escola de Saúde Pública do Ceará
facility: 
country: Brazil
responsible party type: Principal Investigator
investigator affiliation: Escola de Saúde Pública do Ceará
investigator full name: Marcelo Alcantara Holanda
investigator title: Doctor
mesh term: COVID-19
mesh term: Respiratory Insufficiency
mesh term: Hypoxia
sharing ipd: No