Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Elmo Respiratory Support Project - COVID-19

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04470258
Recruitment Status : Recruiting
First Posted : July 14, 2020
Last Update Posted : November 27, 2020
Sponsor:
Information provided by (Responsible Party):
Marcelo Alcantara Holanda, Escola de Saúde Pública do Ceará

Tracking Information
First Submitted Date  ICMJE June 10, 2020
First Posted Date  ICMJE July 14, 2020
Last Update Posted Date November 27, 2020
Actual Study Start Date  ICMJE August 2, 2020
Actual Primary Completion Date September 29, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 11, 2020)
  • 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.
  • 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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 11, 2020)
  • 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.
  • 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.
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Elmo Respiratory Support Project - COVID-19
Official Title  ICMJE Elmo Respiratory Support Project for Patients With Hypoxemic Respiratory Insufficiency in Covid-19: Proof Of Concept and Usability
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.
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Device Feasibility
Condition  ICMJE
  • COVID-19
  • Respiratory Failure With Hypoxia
Intervention  ICMJE
  • 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.
  • 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.
Study Arms  ICMJE
  • 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.
    Intervention: Device: ELMO PROJECT AT COVID-19: PROOF OF CONCEPT AND USABILITY
  • 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.
    Intervention: Other: ELMO PROJECT AT COVID-19: STUDY IN HUMANS
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: July 11, 2020)
10
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2020
Actual Primary Completion Date September 29, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: MARCELO HOLANDA, Doctor +55 (085) 99973-0714 marceloalcantara2@gmail.com
Listed Location Countries  ICMJE Brazil
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04470258
Other Study ID Numbers  ICMJE 4.104.233
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Marcelo Alcantara Holanda, Escola de Saúde Pública do Ceará
Study Sponsor  ICMJE Escola de Saúde Pública do Ceará
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: MARCELO HOLANDA, Doctor Escola de Saúde Pública do Ceará
PRS Account Escola de Saúde Pública do Ceará
Verification Date November 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP