Elmo Respiratory Support Project - COVID-19

NCT04470258 | Completed

• 1 other identifier: 4.104.233
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

COVID-19; Respiratory Failure With Hypoxia

Keywords

COVID-19; Accute breathing failure; Continuous Positive Airway Pressure; Usability

Outcome Measures

Primary Outcomes (2)

• Usability tests of the Elmo system using Euristic usability principles

  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.

  One week after all tests

• Evaluation of the effectiveness of the ELMO system using physiological parameters

  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.

  One week after all tests

Secondary Outcomes (4)

• Evaluation of the effectiveness of the ELMO system using physiological parameters

  One week after all tests

• Evaluation of the effectiveness of the ELMO system using physiological parameters

  One week after all tests

• Evaluation of the effectiveness of the ELMO system using physiological parameters

  One week after all tests

• Evaluation of the effectiveness of the ELMO system using physiological parameters

  One week after all tests

Study Arms (2)

ELMO PROJECT AT COVID-19: PROOF OF CONCEPT AND USABILITY

OTHER

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

ELMO PROJECT AT COVID-19: STUDY IN HUMANS

OTHER

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

Interventions

ELMO PROJECT AT COVID-19: STUDY IN HUMANS OTHER

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.

ELMO PROJECT AT COVID-19: STUDY IN HUMANS

ELMO PROJECT AT COVID-19: PROOF OF CONCEPT AND USABILITY DEVICE

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: PROOF OF CONCEPT AND USABILITY

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult patient, age\> or = 18 years, both sexes;
• Patient should be alert, oriented, and cooperative;
• When using oxygen therapy by CNO2\> or = 4L/min, MR\> or = 8 L/min of O2 or MV 50%, for maintain SpO2\> 92%;
• Gasometric parameters (pre ELMO, up to 30 min before): pH\> 7.35, PaO2\> 60 mmHg;
• RX or chest CT scan with bilateral parenchymal opacities from the last 24 hours.

You may not qualify if:

• Exacerbation of Asthma, Chronic Obstructive Pulmonary Disease (COPD), pulmonary fibrosis or other lung diseases;
• Hemodynamic instability (SBP \<90 mmHg or MBP \<65 mmHg or need for vasoactive drugs);
• Pneumothorax or pneumomediastinum;
• Respiratory acidosis (pH \<7.35 with PaCO2 \>46mmHg);
• Signs of respiratory muscle fatigue (paradoxical breathing, accessory muscle use);
• Nausea or vomiting;
• Disorders of the auditory canal;
• Use of nasoenteric or nasogastric feeding tubes;
• Imminent risk of respiratory arrest.

Sponsors & Collaborators

• Escola de Saúde Pública do Ceará: lead

Study Sites (1)

Hospital Leonardo Da Vinci

Fortaleza, Brazil

Location

Related Publications (1)

• Tomaz BS, Gomes GC, Lino JA, Menezes DGA, Soares JB, Furtado V, Soares Junior L, Farias MDSQ, Lima DLN, Pereira EDB, Holanda MA. ELMO, a new helmet interface for CPAP to treat COVID-19-related acute hypoxemic respiratory failure outside the ICU: a feasibility study. J Bras Pneumol. 2022 Feb 2;48(1):e20210349. doi: 10.36416/1806-3756/e20210349. eCollection 2022.

  PMID: 35137871 DERIVED

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• MARCELO HOLANDA, Doctor

  Escola de Saúde Pública do Ceará

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor

Study Record Dates

• First Submitted: June 10, 2020
• First Posted: July 14, 2020
• Study Start: June 25, 2020
• Primary Completion: August 30, 2020
• Study Completion: November 30, 2020
• Last Updated: April 20, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)