Status:
COMPLETED
Elmo Respiratory Support Project - COVID-19
Lead Sponsor:
Escola de Saúde Pública do Ceará
Conditions:
COVID-19
Respiratory Failure With Hypoxia
Eligibility:
All Genders
18+ years
Phase:
NA
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 b...
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 t...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
June 25 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 30 2020
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT04470258
Start Date
June 25 2020
End Date
November 30 2020
Last Update
April 20 2021
Active Locations (1)
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1
Hospital Leonardo Da Vinci
Fortaleza, Brazil