Proposal for International Standardization of the Use of Lung Ultrasound for COVID-19 Patients; a Simple, Quantitative, Reproducible Method
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 220
- 试验地点
- 9
- 主要终点
- Lung ultrasound grading system for COVID-19 pneumonia
研究概览
简要总结
Growing evidences are showing the usefulness of lung ultrasound in patients with COVID-19. Sars-CoV-2 has now spread in almost every country in the world. In this study, the investigators share their experience and propose a standardized approach in order to optimize the use of lung ultrasound in covid-19 patients. The investigators focus on equipment, procedure, classification and data-sharing.
详细描述
COVID-19 global emergency need a global unified approach, speaking all researchers the same language. For this reason, the investigators propose a standardization for the international use of lung ultrasound (LUS) for the management of COVID-19 patients.
The LUS COVID-team is made by Italian experts in lung ultrasound currently involved in the clinical management of COVID-19 patients in different Italian areas, including the heavily involved cities of Northern Italy. Moreover, experts in ultrasound physics and image analysis are part of the team.
The team developed a standardized approach regarding equipment and acquisition protocol. Moreover, the team proposed a scoring system for severity classification. To this aim, clinicians shared 20 cases of confirmed COVID-19 on an anonymized virtual database, for a total of about 44000 frames up to date. All team members discussed their clinical cases through online meetings. Images were reviewed by all team members, blinded to the clinical background, and listed in classes of severity of lung involvement based on LUS images. At the end of this process, a biomedical engineer expert in lung ultrasound collected the data and suggested a lung ultrasound grading system for COVID-19 pneumonia. Again, the biomedical engineer re-submitted the images grouped in different classes of severity to the study members, blinded of clinical data, to review again the images and evaluated agreement regarding the LUS scores. The score was defined only when all team members agreed.
Methods In the setting of COVID-19, wireless probe and tablets represent the most appropriate ultrasound equipment. These devices can easily be wrapped in single use plastic covers reducing the risk of contamination and making easy the sterilization procedures. Such devices are much less expensive than usual ultrasound machines including the portable ones.
In case of unavailability of these devices, portable machines dedicated to the exclusive use of COVID-19 patients can be used, although maximum care for sterilization is necessary. In these cases, probe and keyboard covers are anyway suggested, and sterilization procedures necessary following last recommendations.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •suspected COVID-19 patients,
- •known COVID-19 patients.
排除标准
- •confirmed disease different from COVID-19.
结局指标
主要结局
Lung ultrasound grading system for COVID-19 pneumonia
时间窗: At enrollment.
Scoring procedures * Score 0: The pleura line is continuous, regular. Horizontal artifacts (A-line) are present. These artifacts are generally referred as A-lines. * Score 1: The pleura line is indented. Below the indent, vertical areas of white are visible. * Score 2: The pleura line is broken. Below the breaking point, small to large consolidated areas (darker areas) appear with associated areas of white below the consolidated area (white lung). * Score 3: The scanned area shows dense and largely extended white lung with or without larger consolidations At the end of the procedure, the clinician will write for each area the highest score obtained.
次要结局
未报告次要终点
研究者
Riccardo Inchingolo
Principal Investigator
Catholic University of the Sacred Heart