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. 2022 Feb 2;48(1):e20210349.
doi: 10.36416/1806-3756/e20210349. eCollection 2022.

ELMO, a new helmet interface for CPAP to treat COVID-19-related acute hypoxemic respiratory failure outside the ICU: a feasibility study

[Article in English, Portuguese]
Betina Santos Tomaz  1 , Gabriela Carvalho Gomes  2 , Juliana Arcanjo Lino  2 , David Guabiraba Abitbol de Menezes  2 , Jorge Barbosa Soares  2 , Vasco Furtado  3 , Luiz Soares Júnior  1 , Maria do Socorro Quintino Farias  4 , Debora Lilian Nascimento Lima  4 , Eanes Delgado Barros Pereira  1 , Marcelo Alcantara Holanda  1   5
Affiliations

ELMO, a new helmet interface for CPAP to treat COVID-19-related acute hypoxemic respiratory failure outside the ICU: a feasibility study

[Article in English, Portuguese]
Betina Santos Tomaz et al. J Bras Pneumol. .

Abstract
in English, Portuguese

Objective: To assess the feasibility of using a new helmet interface for CPAP, designated ELMO, to treat COVID-19-related acute hypoxemic respiratory failure (AHRF) outside the ICU.

Methods: This was a proof-of-concept study involving patients with moderate to severe AHRF secondary to COVID-19 admitted to the general ward of a public hospital. The intervention consisted of applying CPAP via the ELMO interface integrated with oxygen and compressed air flow meters (30 L/min each) and a PEEP valve (CPAP levels = 8-10 cmH2O), forming the ELMOcpap system. The patients were monitored for cardiorespiratory parameters, adverse events, and comfort.

Results: Ten patients completed the study protocol. The ELMOcpap system was well tolerated, with no relevant adverse effects. Its use was feasible outside the ICU for a prolonged amount of time and was shown to be successful in 60% of the patients. A CPAP of 10 cmH2O with a total gas flow of 56-60 L/min improved oxygenation after 30-to 60-min ELMOcpap sessions, allowing a significant decrease in estimated FIO2 (p = 0.014) and an increase in estimated PaO2/FIO2 ratio (p = 0.008) within the first hour without CO2 rebreathing.

Conclusions: The use of ELMOcpap has proven to be feasible and effective in delivering high-flow CPAP to patients with COVID-19-related AHRF outside the ICU. There were no major adverse effects, and ELMO was considered comfortable. ELMOcpap sessions significantly improved oxygenation, reducing FIO2 without CO2 rebreathing. The overall success rate was 60% in this pilot study, and further clinical trials should be carried out in the future.(ClinicalTrials.gov identifier: NCT04470258 [http://www.clinicaltrials.gov/]).

Objetivo:: Avaliar a viabilidade do uso de uma nova interface do tipo capacete para CPAP, denominada ELMO, para o tratamento da insuficiência respiratória aguda (IRpA) hipoxêmica por COVID-19 fora da UTI.

Métodos:: Estudo de prova de conceito envolvendo pacientes com IRpA hipoxêmica moderada a grave secundária à COVID-19, internados na enfermaria geral de um hospital público. A intervenção consistiu na aplicação de CPAP por meio da interface ELMO integrada a fluxômetros de oxigênio e ar comprimido (30 L/min cada) e a uma válvula de PEEP (níveis de CPAP = 8-10 cmH2O), formando o sistema ELMOcpap. Os pacientes foram monitorados quanto a parâmetros cardiorrespiratórios, eventos adversos e conforto.

Resultados:: Dez pacientes completaram o protocolo do estudo. O sistema ELMOcpap foi bem tolerado, sem efeitos adversos relevantes. Seu uso foi viável fora da UTI por tempo prolongado e mostrou-se bem-sucedido em 60% dos pacientes. Uma CPAP de 10 cmH2O com fluxo total de gás de 56-60 L/min melhorou a oxigenação após sessões de ELMOcpap de 30-60 min, permitindo redução significativa da FIO2 estimada (p = 0,014) e aumento da PaO2/FIO2 estimada (p = 0,008) na primeira hora, sem reinalação de CO2.

Conclusões:: O uso do ELMOcpap mostrou-se viável e eficaz no fornecimento de CPAP de alto fluxo a pacientes com IRpA hipoxêmica por COVID-19 fora da UTI. Não houve nenhum efeito adverso importante, e o ELMO foi considerado confortável. As sessões de ELMOcpap melhoraram significativamente a oxigenação, reduzindo a FIO2 sem reinalação de CO2. A taxa global de sucesso foi de 60% neste estudo piloto, e novos ensaios clínicos devem ser realizados.

(ClinicalTrials.gov identifier: NCT04470258 [http://www.clinicaltrials.gov/])

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Conflict of interest statement

CONFLICT OF INTEREST: None declared.

Figures

Figure 1
Figure 1. Images showing the components of the ELMOcpap system. HEPA: high-efficiency particulate air; and HME: heat and moisture exchanger.
Figure 2
Figure 2. Flow chart of the patient selection process.
Figure 3
Figure 3. Arterial blood gas parameters before the first ELMOcpap session and after 30-60 min of use (CPAP = 10 cmH2O and total gas flow = 56-60 L/min) in individual patients (P1-P6,P9,10). There were significant improvements in PaO2, SaO2, and estimated PaO2/FIO2 30-60 min after starting ELMOcpap use. These improvements made it possible to reduce median estimated FIO2 (from 0.77 [0.65-0.89] to 0.60 [0.49-0.61]; p = 0.014). *p < 0.05.
See this image and copyright information in PMC

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