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

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/]).

ELMO, a new helmet interface for CPAP to treat COVID-19-related acute hypoxemic respiratory failure outside the ICU: a feasibility study / ELMO, uma nova interface do tipo capacete para CPAP no tratamento da insuficiência respiratória aguda hipoxêmica por COVID-19 fora da UTI: estudo de viabilidade

ABSTRACT 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/])

RESUMO 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/])

Acute effects of noninvasive ventilation on sleep physiology in patients with moderate to severe stable chronic obstructive pulmonary disease: a pilot study.

OBJECTIVE/BACKGROUND: Changes in sleep architecture in patients with Chronic Obstructive Pulmonary Disease (COPD) can be explained by a combination of physiological changes in breathing during sleep, with impairment of respiratory mechanics and reduction of arterial oxygenation. This study aimed to evaluate the acute effects of noninvasive ventilation (NIV) - compared to spontaneous breathing - on sleep latency and stages, and on the occurrence of sleep-related respiratory events, nocturnal hypoxemia, and changes in heart rate (HR) in patients with moderate to severe stable COPD. PATIENTS/METHODS: Patients completed two polysomnography (PSG) studies: one during spontaneous breathing and one while receiving NIV in bilevel mode and with backup respiratory rate (RR.) setting. Sleepware G3 software was used for the analysis of PSG and pressure, volume, and ventilator flow curves × time. RESULTS: Participants were 10 female patients with a mean age of 68.1 ± 10.2 years. NIV during sleep decreased sleep onset latency (17 ± 18.8 min vs 46.8 ± 39.5 min; p = 0.02), increased REM sleep time (41.2 ± 24.7 min vs 19.7 ± 21.7 min; p = 0.03), and decreased the obstructive apnea index (OAI) (0 vs 8.7 ± 18.8; p = 0.01). Lower mean HR (66.6 ± 4.1 bpm vs 70.6 ± 5.9 bpm; p = 0.03) and lower maximum HR (84.1 ± 7.3 bpm vs 91.6 ± 7.8 bpm; p = 0.03) were observed in PSG with NIV. CONCLUSIONS: The use of NIV in patients with moderate to severe stable COPD while they were sleeping increased REM sleep time and decreased sleep onset latency, the number of obstructive respiratory events, and the mean and maximum HR.

A Critical Review of Mechanical Ventilation Virtual Simulators: Is It Time to Use Them?

BACKGROUND: Teaching mechanical ventilation at the bedside with real patients is difficult with many logistic limitations. Mechanical ventilators virtual simulators (MVVS) may have the potential to facilitate mechanical ventilation (MV) training by allowing Web-based virtual simulation. OBJECTIVE: We aimed to identify and describe the current available MVVS, to compare the usability of their interfaces as a teaching tool and to review the literature on validation studies. METHODS: We performed a comparative evaluation of the MVVS, based on a literature/Web review followed by usability tests according to heuristic principles evaluation of their interfaces as performed by professional experts on MV. RESULTS: Eight MVVS were identified. They showed marked heterogeneity, mainly regarding virtual patient's anthropomorphic parameters, pulmonary gas exchange, respiratory mechanics and muscle effort configurations, ventilator terminology, basic ventilatory modes, settings alarms, monitoring parameters, and design. The Hamilton G5 and the Xlung covered a broader number of parameters, tools, and have easier Web-based access. Except for the Xlung, none of the simulators displayed monitoring of arterial blood gases and alternatives to load and save the simulation. The Xlung obtained the greater scores on heuristic principles assessments and the greater score of easiness of use, being the preferred MVVS for teaching purposes. No strong scientific evidence on the use and validation of the current MVVS was found. CONCLUSIONS: There are only a few MVVS currently available. Among them, the Xlung showed a better usability interface. Validation tests and development of new or improvement of the current MVVS are needed.