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.

Study Overview

• Status: Recruiting
• Conditions: COVID-19
• Intervention / Treatment: Other: Clinical Observation

Detailed Description

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.

• Study Type: Observational
• Enrollment (Anticipated): 2000

Contacts and Locations

• Study Contact: Name: Luiza G Frota, PHD; Phone Number: 8499 558533668499; Email: gabigomes1@hotmail.com

Study Locations

• Brazil
  • Ceara
    • Fortaleza, Ceara, Brazil, 60135-285
      • Recruiting
      • Hospital Leonardo Da Vinci
      • Contact: Marcelo A Holanda, PHD; Phone Number: +558531011398; Email: cep@esp.ce.gov.br

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

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.

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 ).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Risk factors for intubation	To evaluate the risk factors for intubation of patients with hypoxemic ARF due to COVID-19 who used the Assisted Breathing Helmet - ELMO.	up to 60 days
Risk factors for death	To evaluate the risk factors for death of patients with hypoxemic ARF due to COVID-19 who used the Assisted Breathing Helmet - ELMO.	up to 90 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to start ELMO therapy	Time to start using the Assisted Breathing Helmet - ELMO	up to 28 days
Total time of use ELMO therapy	Total time of use of the Assisted Breathing Helmet - ELMO	up to 60 days
Adverse events of ELMO	Adverse events with the use of the Assisted Breathing Helmet - ELMO	up to 60 days

Collaborators and Investigators

• Sponsor: Escola de Saúde Pública do Ceará
• Investigators: Principal Investigator: Marcelo A Holanda, PHD, Escola Saude Publica

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2021
• Primary Completion (Anticipated): August 30, 2022
• Study Completion (Anticipated): December 30, 2022

Study Registration Dates

• First Submitted: May 14, 2022
• First Submitted That Met QC Criteria: May 14, 2022
• First Posted (Actual): May 17, 2022

Study Record Updates

• Last Update Posted (Actual): June 14, 2022
• Last Update Submitted That Met QC Criteria: June 10, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Keywords: Continuous Positive Airway Pressure; COVID-19; Acute breathing insufficiency
• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19
• Other Study ID Numbers: 4.833.400

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: The investigators haven't developed a plan for sharing, but would be open to share unidentified data for research or public health purposes.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No