Clinical and Electronic Record for Patients With COVID-19 Treated With the Assisted Breathing Helmet - ELMO in Ceará (COVID-19)
Continuous positive airway pressure (CPAP) with a helmet-like interface has been described as a safe strategy, with minimal contamination of the environment, improving the oxygenation of patients with acute respiratory failure (ARF) by COVID-19, avoiding intubation in more than half of the cases. ELMOcpap, developed in Ceará, was a great ally in the treatment of these cases during the pandemic in the state. It is estimated that among public and private services, more than 1.400 ELMOs have been applied to patients with COVID-19. However, the determining factors of the success and failure of its use in the different institutions in which it has been applied are still unknown. Therefore, it is 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 with hypoxemic respiratory failure due to COVID-19 in a database, in a systematic and standardized way, on clinical history, efficacy, safety, modes, duration of use, the occurrence of adverse events and early predictors of failure. 2. Determine the intubation rate of patients with COVID-19 hypoxemic respiratory failure who used the ELMO. 3. Identify the mortality rate of patients with hypoxemic respiratory failure due to COVID-19 who used the ELMO.
Methods: This is a retrospective, multicenter, observational, cohort study of recorded data from patients with COVID-19 hypoxemic respiratory failure who were treated with the ELMO. 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 and analysis will be carried out of the data of the patients of the participating services of the research that used the ELMO as treatment.
Studieöversikt
Detaljerad beskrivning
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.
Studietyp
Inskrivning (Förväntat)
Kontakter och platser
Studiekontakt
- Namn: Luiza G Frota, PHD
- Telefonnummer: 8499 558533668499
- E-post: gabigomes1@hotmail.com
Studieorter
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Ceara
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Fortaleza, Ceara, Brasilien, 60135-285
- Rekrytering
- Hospital Leonardo Da Vinci
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Kontakt:
- Marcelo A Holanda, PHD
- Telefonnummer: +558531011398
- E-post: cep@esp.ce.gov.br
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-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Testmetod
Studera befolkning
Patients with COVID-19, confirmed by laboratory detection of SARS-CoV-2 RNA, who used the Assisted Breathing Helmet - ELMO in referral hospitals in Fortaleza, Brazil.
Data will be collected retrospectively from adult patients admitted to the ICU and wards during the COVID-19 pandemic in Fortaleza.
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.
Beskrivning
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.
Studieplan
Hur är studien utformad?
Designdetaljer
Kohorter och interventioner
Grupp / Kohort |
Intervention / Behandling |
|---|---|
|
COVID-19 in use of ELMO
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 severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) RNA, who used the Assisted Breathing Helmet - ELMO.
|
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 ). |
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Risk factors for intubation
Tidsram: up to 60 days
|
To evaluate the risk factors for intubation of patients with hypoxemic ARF due to COVID-19 who used the Assisted Breathing Helmet - ELMO.
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up to 60 days
|
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Risk factors for death
Tidsram: up to 90 days
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To evaluate the risk factors for death of patients with hypoxemic ARF due to COVID-19 who used the Assisted Breathing Helmet - ELMO.
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up to 90 days
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Time to start ELMO therapy
Tidsram: up to 28 days
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Time to start using the Assisted Breathing Helmet - ELMO
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up to 28 days
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|
Total time of use ELMO therapy
Tidsram: up to 60 days
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Total time of use of the Assisted Breathing Helmet - ELMO
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up to 60 days
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Adverse events of ELMO
Tidsram: up to 60 days
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Adverse events with the use of the Assisted Breathing Helmet - ELMO
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up to 60 days
|
Samarbetspartners och utredare
Sponsor
Utredare
- Huvudutredare: Marcelo A Holanda, PHD, Escola Saude Publica
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Förväntat)
Avslutad studie (Förväntat)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 4.833.400
Plan för individuella deltagardata (IPD)
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