COVID-19NCT04470258
Elmo Respiratory Support Project - COVID-19
A study testing ELMO PROJECT AT COVID-19: STUDY IN HUMANS and ELMO PROJECT AT COVID-19: PROOF OF CONCEPT AND USABILITY in people with COVID-19 and Respiratory Failure With Hypoxia, run by Escola de Saúde Pública do Ceará at 1 site in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COVID-19, Respiratory Failure With Hypoxia
- What is being tested?
- ELMO PROJECT AT COVID-19: STUDY IN HUMANS and ELMO PROJECT AT COVID-19: PROOF OF CONCEPT AND USABILITY
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteBrazil
- Study dates
- 25 Jun 2020to 30 Nov 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
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- Disorders of the auditory canal;
- Use of nasoenteric or nasogastric feeding tubes;
- Imminent risk of respiratory arrest.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Elmo Respiratory Support Project for Patients With Hypoxemic Respiratory Insufficiency in Covid-19: Proof Of Concept and Usability
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.
Read the 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.
- Conditions
- COVID-19, Respiratory Failure With Hypoxia
- Being tested
- ELMO PROJECT AT COVID-19: STUDY IN HUMANS, ELMO PROJECT AT COVID-19: PROOF OF CONCEPT AND USABILITY
- Keywords
- COVID-19, Accute breathing failure, Continuous Positive Airway Pressure, Usability
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ELMO PROJECT AT COVID-19: STUDY IN HUMANSOther
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: PROOF OF CONCEPT AND USABILITYDevice
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 group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: ELMO PROJECT AT COVID-19: STUDY IN HUMANS |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: One week after all tests
Secondary outcomes (4)
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 respiratory rate (irpm) before, during and after the application of Elmo.
Measured: 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 heart rate before, during and after the application of Elmo.
Measured: 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 blood pressure before, during and after the application of Elmo.
Measured: 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 CO2 measurement at the end of exhalation (mmHg) before, during and after the application of Elmo.
Measured: One week after all tests
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2020
- Study start25 Jun 2020
- Primary completion30 Aug 2020
- Study completion30 Nov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for COVID-19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Device feasibility
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Escola de Saúde Pública do Ceará
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Marcelo Alcantara Holanda, Escola de Saúde Pública do Ceará
- Investigators
- MARCELO HOLANDA, Doctor, Principal investigator, Escola de Saúde Pública do Ceará
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04470258
- Sponsor's protocol ID
- 4.104.233
- Status last verified
- Apr 2021
- First submitted
- 10 Jun 2020
- Last updated
- 20 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 35137871
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Elmo Respiratory Support Project for Patients With Hypoxemic Respiratory Insufficiency in Covid-19: Proof Of Concept and Usability
- ClinicalTrials.gov ID
- NCT04470258
- Acronym / sponsor ID
- 4.104.233
- Conditions
- COVID-19, Respiratory Failure With Hypoxia
- Keywords
- COVID-19, Accute breathing failure, Continuous Positive Airway Pressure, Usability
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Escola de Saúde Pública do CearáOther government
- Study start
- 25 Jun 2020 (actual)
- Primary completion
- 30 Aug 2020 (actual)
- Study completion
- 30 Nov 2020 (actual)
- First posted
- 14 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Device feasibility
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ELMO PROJECT AT COVID-19: PROOF OF CONCEPT AND USABILITY | Other | Device: ELMO PROJECT AT COVID-19: PROOF OF CONCEPT AND USABILITYA 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. |
| ELMO PROJECT AT COVID-19: STUDY IN HUMANS | Other | Other: ELMO PROJECT AT COVID-19: STUDY IN HUMANSThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (9 listed)
- 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);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ELMO PROJECT AT COVID-19: STUDY IN HUMANSThe 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. | Other | ELMO PROJECT AT COVID-19: STUDY IN HUMANS |
| ELMO PROJECT AT COVID-19: PROOF OF CONCEPT AND USABILITYAfter 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. | Device | ELMO PROJECT AT COVID-19: PROOF OF CONCEPT AND USABILITY |
Primary outcome
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.
4 secondary outcomes
Evaluation of the effectiveness of the ELMO system using physiological parameters
Time frame: One week after all tests
Evaluation of the effectiveness of the ELMO system using physiological parameters
Time frame: One week after all tests
Evaluation of the effectiveness of the ELMO system using physiological parameters
Time frame: One week after all tests
Evaluation of the effectiveness of the ELMO system using physiological parameters
Time frame: One week after all tests
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2021.
- Derived from this study: PubMed 35137871Tomaz 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
MARCELO HOLANDA, Doctor principal investigator
Escola de Saúde Pública do Ceará
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ELMO PROJECT AT COVID-19: STUDY IN HUMANS and ELMO PROJECT AT COVID-19: PROOF OF CONCEPT AND USABILITY in people with COVID-19 and Respiratory Failure With Hypoxia, run by Escola de Saúde Pública do Ceará at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Usability tests of the Elmo system using Euristic usability principles (time frame: One week after all tests). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04470258, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Apr 2021; AzTrials last refreshed its copy on 26 Oct 2026.