Continuous positive airway pressure (CPAP) with a helmet-like interface has beendescribed as a safe strategy, with minimal contamination of the environment, improvingthe oxygenation of patients with acute respiratory failure (ARF) by COVID-19, avoidingintubation in more than half of the cases. ELMOcpap, developed in Ceará, was a great allyin the treatment of these cases during the pandemic in the state. It is estimated thatamong public and private services, more than 1.400 ELMOs have been applied to patientswith COVID-19. However, the determining factors of the success and failure of its use inthe different institutions in which it has been applied are still unknown. Therefore, itis necessary to survey all data associated with the use of the device.Objectives: 1. To describe the effects of ELMO in the treatment of patients withhypoxemic respiratory failure due to COVID-19 in a database, in a systematic andstandardized way, on clinical history, efficacy, safety, modes, duration of use, theoccurrence of adverse events and early predictors of failure. 2. Determine the intubationrate of patients with COVID-19 hypoxemic respiratory failure who used the ELMO. 3.Identify the mortality rate of patients with hypoxemic respiratory failure due toCOVID-19 who used the ELMO.Methods: This is a retrospective, multicenter, observational, cohort study of recordeddata from patients with COVID-19 hypoxemic respiratory failure who were treated with theELMO. An online electronic form will be developed with REDCap, where the responsibleinvestigator of each institution will be responsible for filling in the participants'data, ensuring adherence to the protocol and analysis will be carried out of the data ofthe patients of the participating services of the research that used the ELMO astreatment.
An online electronic form will be developed with REDCap, where the responsible
investigator of each institution will be responsible for filling in the participants'
data, ensuring adherence to the protocol.
The researchers involved will undergo qualified training and will receive a video,
showing step-by-step how REDCap works, so that there are no doubts about the data
collection process and to ensure the standardization of the collection protocol.
An explanation of the nature and objectives of the study will be presented to the
research subjects, as well as its importance to society, health professionals and
researchers.
The investigators will visit the hospital at least five times a week in the morning,
afternoon and/or night shifts, for data collection, with monitoring and collection of
outcomes being performed daily.
Other: Clinical Observation
This is an observational study, so there are no interventions. Data will be recruited
from adult patients diagnosed with COVID-19, described in medical records, by laboratory
detection of SARS-CoV-2 RNA, who used the Assisted Breathing Helmet - ELMO.
All the following predictor variables will be collected: demographic and anthropometric
data; clinical characteristics of patients (comorbidities, date of onset of symptoms and
initial symptoms, hospital admission, laboratory tests, chest X-ray tests, need for
intubation or ICU admission); start date of ELMO use, blood gas analysis before and after
the first application of ELMO and data related to its use (number of applications, number
of days of therapy, total time of therapy, as well as reasons for the interruption and
adverse effects ).
Inclusion Criteria:
- Data from adult patients diagnosed with COVID-19 described in medical records by
laboratory detection of RNA of SARS-CoV-2, who used the Assisted Breathing Helmet -
ELMO, will be recruited.
Exclusion Criteria:
- Illegible medical records or forms or with incomplete data that make it impossible
to collect data will be excluded.
Hospital Leonardo Da Vinci
Fortaleza, Ceara, Brazil
Investigator: Marcelo A Holanda, PHD
Contact: +558531011398
cep@esp.ce.gov.br
Luiza G Frota, PHD
558533668499 - 8499
gabigomes1@hotmail.com
Marcelo A Holanda, PHD, Principal Investigator
Escola Saude Publica