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Clinical and Electronic Record for Patients With COVID-19 Treated With the Assisted Breathing Helmet - ELMO in Ceará (COVID-19)

2022年6月10日 更新者:Marcelo Alcantara Holanda、Escola de Saúde Pública do Ceará

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.

研究概览

地位

招聘中

条件

详细说明

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.

研究类型

观察性的

注册 (预期的)

2000

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习联系方式

学习地点

    • Ceara
      • Fortaleza、Ceara、巴西、60135-285
        • 招聘中
        • Hospital Leonardo Da Vinci
        • 接触:

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 及以上 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

取样方法

非概率样本

研究人群

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.

描述

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.

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

队列和干预

团体/队列
干预/治疗
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 ).

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Risk factors for intubation
大体时间: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.
up to 60 days
Risk factors for death
大体时间:up to 90 days
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

次要结果测量

结果测量
措施说明
大体时间
Time to start ELMO therapy
大体时间:up to 28 days
Time to start using the Assisted Breathing Helmet - ELMO
up to 28 days
Total time of use ELMO therapy
大体时间:up to 60 days
Total time of use of the Assisted Breathing Helmet - ELMO
up to 60 days
Adverse events of ELMO
大体时间:up to 60 days
Adverse events with the use of the Assisted Breathing Helmet - ELMO
up to 60 days

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 首席研究员:Marcelo A Holanda, PHD、Escola Saude Publica

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2021年9月1日

初级完成 (预期的)

2022年8月30日

研究完成 (预期的)

2022年12月30日

研究注册日期

首次提交

2022年5月14日

首先提交符合 QC 标准的

2022年5月14日

首次发布 (实际的)

2022年5月17日

研究记录更新

最后更新发布 (实际的)

2022年6月14日

上次提交的符合 QC 标准的更新

2022年6月10日

最后验证

2022年6月1日

更多信息

与本研究相关的术语

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

未定

IPD 计划说明

The investigators haven't developed a plan for sharing, but would be open to share unidentified data for research or public health purposes.

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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