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ELMO,一种用于 CPAP 治疗 COVID-19 相关急性低氧性呼吸衰竭的新型头盔接口:一项可行性研究。

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

机构信息

. Universidade Federal do Ceará - UFC - Fortaleza (CE) Brasil.

. Fundação Cearense de Apoio ao Desenvolvimento Científico e Tecnológico - FUNCAP - Fortaleza (CE) Brasil.

出版信息

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

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/]).

摘要

目的

评估一种新型 CPAP 头盔接口(ELMO)在 ICU 外治疗 COVID-19 相关急性低氧性呼吸衰竭(AHRF)的可行性。

方法

这是一项概念验证研究,涉及因 COVID-19 而导致中度至重度 AHRF 并收入公立医院普通病房的患者。干预措施包括应用 ELMO 接口进行 CPAP 治疗,该接口与氧气和压缩空气流量计(各 30 L/min)以及 PEEP 阀(CPAP 水平= 8-10 cmH2O)集成,形成 ELMOcpap 系统。对患者的心肺参数、不良事件和舒适度进行监测。

结果

10 名患者完成了研究方案。ELMOcpap 系统耐受性良好,无相关不良事件。它在 ICU 外长时间使用是可行的,在 60%的患者中取得了成功。在 30-60 分钟的 ELMOcpap 治疗后,使用 10 cmH2O 的 CPAP 和 56-60 L/min 的总气体流量可改善氧合,使估计的 FIO2 显著降低(p = 0.014),估计的 PaO2/FIO2 比值增加(p = 0.008),且在第一个小时内无 CO2 重吸入。

结论

在 ICU 外,ELMOcpap 用于 COVID-19 相关 AHRF 患者高流量 CPAP 的治疗已被证明是可行且有效的。没有出现重大不良事件,且 ELMO 被认为是舒适的。ELMOcpap 治疗显著改善了氧合,降低了 FIO2 且无 CO2 重吸入。在这项初步研究中,总体成功率为 60%,未来应开展更多临床试验。(ClinicalTrials.gov 标识符:NCT04470258 [http://www.clinicaltrials.gov/])。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/6c26/8836630/93c823992aa1/1806-3756-jbpneu-48-01-e20210349-gf1.jpg

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