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Elmo Respiratory Support Project - COVID-19

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ClinicalTrials.gov Identifier: NCT04470258
Recruitment Status : Not yet recruiting
First Posted : July 14, 2020
Last Update Posted : July 14, 2020
Sponsor:
Information provided by (Responsible Party):
Marcelo Alcantara Holanda, Escola de Saúde Pública do Ceará

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
COVID-19 Respiratory Failure With Hypoxia Other: ELMO PROJECT AT COVID-19: STUDY IN HUMANS Device: ELMO PROJECT AT COVID-19: PROOF OF CONCEPT AND USABILITY Not Applicable

Detailed Description:

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Device Feasibility
Official Title: Elmo Respiratory Support Project for Patients With Hypoxemic Respiratory Insufficiency in Covid-19: Proof Of Concept and Usability
Estimated Study Start Date : August 2020
Estimated Primary Completion Date : September 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
ELMO PROJECT AT COVID-19: PROOF OF CONCEPT AND USABILITY
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.
Device: ELMO PROJECT AT COVID-19: PROOF OF CONCEPT AND USABILITY
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.

ELMO PROJECT AT COVID-19: STUDY IN HUMANS
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.
Other: ELMO PROJECT AT COVID-19: STUDY IN HUMANS
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.




Primary Outcome Measures :
  1. Usability tests of the Elmo system using Euristic usability principles [ Time Frame: One week after all tests ]
    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.

  2. Evaluation of the effectiveness of the ELMO system using physiological parameters [ Time Frame: One week after all tests ]
    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.


Secondary Outcome Measures :
  1. Evaluation of the effectiveness of the ELMO system using physiological parameters [ Time Frame: One week after all tests ]
    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.

  2. Evaluation of the effectiveness of the ELMO system using physiological parameters [ Time Frame: One week after all tests ]
    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.

  3. Evaluation of the effectiveness of the ELMO system using physiological parameters [ Time Frame: One week after all tests ]
    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.

  4. Evaluation of the effectiveness of the ELMO system using physiological parameters [ Time Frame: One week after all tests ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adult patient, age> or = 18 years, both sexes;
  • When using oxygen therapy by CNO2> 4 l / min, MR> or = 10 l / min of O2 or MV 50%, for maintain SpO2> 92%;
  • f> 25irpm;
  • Gasometric parameters (pre ELMO, up to 30 min before): pH> 7.35, PaO2> 70 mmHg, PaCO2 between 35 and 45 mmHg, with PaO2 / FIO2 < or = 250, EtCO2 < or = 40 mmHg;
  • RX or chest CT scan with bilateral parenchymal opacities from the last 24 hours.

Exclusion Criteria:

  • Glasgow coma scale <13;
  • Exacerbation of Asthma, COPD or other pneumopathies;
  • Pathologies of the auditory canal;
  • Clear signs of respiratory muscle fatigue (eg, movement paradoxical breathing, use of accessory muscles);
  • Ineffective cough or inability to swallow;
  • Use of nasoenteral or nasogastric tubes;
  • Claustrophobia;
  • Bloating, nausea or vomiting;
  • Hemodynamic instability (SBP <90 mmHg or MBP <65 mmHg);
  • Imminent risk of respiratory arrest.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04470258


Contacts
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Contact: MARCELO HOLANDA, Doctor +55 (085) 99973-0714 marceloalcantara2@gmail.com

Sponsors and Collaborators
Escola de Saúde Pública do Ceará
Investigators
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Principal Investigator: MARCELO HOLANDA, Doctor Escola de Saúde Pública do Ceará
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Responsible Party: Marcelo Alcantara Holanda, Doctor, Escola de Saúde Pública do Ceará
ClinicalTrials.gov Identifier: NCT04470258    
Other Study ID Numbers: 4.104.233
First Posted: July 14, 2020    Key Record Dates
Last Update Posted: July 14, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Marcelo Alcantara Holanda, Escola de Saúde Pública do Ceará:
COVID-19
Accute breathing failure
Continuous Positive Airway Pressure
Usability
Additional relevant MeSH terms:
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Respiratory Insufficiency
Hypoxia
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory