- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04470258
Elmo Respiratory Support Project - COVID-19
Elmo Respiratory Support Project for Patients With Hypoxemic Respiratory Insufficiency in Covid-19: Proof Of Concept and Usability
Study Overview
Status
Conditions
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
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Fortaleza, Brazil
- Hospital Leonardo Da Vinci
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: DEVICE_FEASIBILITY
- Allocation: NON_RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
OTHER: 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.
|
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.
|
OTHER: 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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
One week after all tests
|
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.
|
One week after all tests
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
One week after all tests
|
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.
|
One week after all tests
|
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.
|
One week after all tests
|
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.
|
One week after all tests
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: MARCELO HOLANDA, Doctor, Escola de Saúde Pública do Ceará
Publications and helpful links
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Coronavirus Infections
- Coronaviridae Infections
- Nidovirales Infections
- RNA Virus Infections
- Virus Diseases
- Infections
- Respiratory Tract Infections
- Respiratory Tract Diseases
- Respiration Disorders
- Pneumonia, Viral
- Pneumonia
- Lung Diseases
- Signs and Symptoms, Respiratory
- COVID-19
- Respiratory Insufficiency
- Hypoxia
Other Study ID Numbers
- 4.104.233
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on COVID-19
-
University of Roma La SapienzaQueen Mary University of London; Università degli studi di Roma Foro Italico; Bios Prevention SrlCompletedPost Acute Sequelae of COVID-19 | Post COVID-19 Condition | Long-COVID | Chronic COVID-19 SyndromeItaly
-
Yang I. PachankisActive, not recruitingCOVID-19 Respiratory Infection | COVID-19 Stress Syndrome | COVID-19 Vaccine Adverse Reaction | COVID-19-Associated Thromboembolism | COVID-19 Post-Intensive Care Syndrome | COVID-19-Associated StrokeChina
-
Massachusetts General HospitalRecruitingPost Acute COVID-19 Syndrome | Long COVID | Post Acute Sequelae of COVID-19 | Long COVID-19United States
-
Indonesia UniversityRecruitingPost-COVID-19 Syndrome | Long COVID | Post COVID-19 Condition | Post-COVID Syndrome | Long COVID-19Indonesia
-
Erasmus Medical CenterDa Vinci Clinic; HGC RijswijkNot yet recruitingPost-COVID-19 Syndrome | Long COVID | Long Covid19 | Post COVID-19 Condition | Post-COVID Syndrome | Post COVID-19 Condition, Unspecified | Post-COVID ConditionNetherlands
-
Dr. Soetomo General HospitalIndonesia-MoH; Universitas Airlangga; Biotis Pharmaceuticals, IndonesiaRecruitingCOVID-19 Pandemic | COVID-19 Vaccines | COVID-19 Virus DiseaseIndonesia
-
University of Witten/HerdeckeInstitut für Rehabilitationsforschung NorderneyCompletedPost-COVID-19 Syndrome | Long-COVID-19 SyndromeGermany
-
University Hospital, Ioannina1st Division of Internal Medicine, University Hospital of IoanninaRecruitingCOVID-19 Pneumonia | COVID-19 Respiratory Infection | COVID-19 Pandemic | COVID-19 Acute Respiratory Distress Syndrome | COVID-19-Associated Pneumonia | COVID 19 Associated Coagulopathy | COVID-19 (Coronavirus Disease 2019) | COVID-19-Associated ThromboembolismGreece
-
Jonathann Kuo, MDActive, not recruitingSARS-CoV2 Infection | Post-COVID-19 Syndrome | Dysautonomia | Post Acute COVID-19 Syndrome | Long COVID | Long Covid19 | COVID-19 Recurrent | Post-Acute COVID-19 | Post-Acute COVID-19 Infection | Post Acute Sequelae of COVID-19 | Dysautonomia Like Disorder | Dysautonomia Orthostatic Hypotension Syndrome | Post... and other conditionsUnited States
Clinical Trials on ELMO PROJECT AT COVID-19: PROOF OF CONCEPT AND USABILITY
-
Xavier University of Louisiana.CompletedCovid19 | Vaccine Hesitancy | Vaccine RefusalUnited States
-
Jiangsu Province Centers for Disease Control and...Academy of Military Medical Sciences,Academy of Military Sciences,PLA ZHONGYIANKE...Recruiting
-
Poitiers University HospitalCompleted
-
Sumitomo Pharma America, Inc.Completed
-
ERYtech PharmaCompletedPancreatic AdenocarcinomaUnited States, United Kingdom, France