Interest of the Use of Pulmonary Ultrasound in the Referral of Patients With or Suspected COVID-19 +
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 328
- 试验地点
- 1
- 主要终点
- Association of pulmonary lesions on ultrasound on D0 classified according to three stages of severity
研究概览
简要总结
The recent pandemic due to the SARS-CoV2 results in a pulmonary infection in major symptomatic patients. Because of the large number of patients and the risk of acute respiratory distress syndrome (which seems to occur in almost 5% of patients), there is a real challenge to improve physician ability to screen between patients those who will require specific surveillance and those who can be sent back home. The recent French official recommendation of the French radiology society prescribe that chest X-ray do not have any place in the COVID-19+ management whereas the WHO stipulate that ultrasound machines may be useful for these patients [1-2]. Moreover, scattered recent publications tend to stress the interest of quick ultrasound imaging for COVID-19 suspected patients for screening purpose [2-5].
The aim of this observational historico-prospective study is to assess the risk of severe clinical outcomes (admission in continuous care unit (USC), invasive respiratory assistance, death) in patients suspected or diagnosed COVID-19+ as a function of initial pulmonary ultrasound abnormalities. These clinical outcomes are assessed through phone calls at D5, D15, M1.
The secondary objectives are:
- Assessing the concordance between the severity of pulmonary lesions as detected by pulmonary ultrasound devices and the ones detected by CT-scanner, for patients who will undergo these two examinations.
- Assessing the compared performances in detecting ultrasound pulmonary lesions for patients suspected or diagnosed COVID-19+, between an experimented operator and a newly trained operator.
- Evaluate in suspected or COVID-19 patients, the risk of clinical worsening based on pulmonary ultrasound abnormalities during follow-up of hospitalized patients.
- Evaluate the ultrasound evolution profiles of pulmonary lesions in patients whose clinical evolution is favorable.
- Evaluate the incidence of thromboembolic events in patients who worsen secondarily.
详细描述
The practitioners involved at each site are
- either emergency physicians who are experts in pulmonary ultrasound
- either newly trained doctors who have received 30 minutes quick training in the fundamentals of pulmonary ultrasound.
The data collected under this protocol consists in:
- data from clinical examination: blood pressure, heart rate, respiratory rate, saturation, signs of confusion, body temperature, calculation of the CRB65 and qSOFA score, date of onset of symptoms
- Former patient journey: home, hospital, nursing home, others
- Medical background
- Recent use in the context of NSAID symptomatology
- Long-term use of nonsteroidal anti-inflammatory drugs (NSAIDs) in the context of a known pathology
- Results and date of PCR-Covid-19 test
- Pulmonary ultrasound results: quotation in 8 fields (right antero-superior, left antero-superior, right antero-inferior, left antero-inferior, right postero-superior, left postero-superior, right postero-inferior and postero-upper left).
- The operator's identity and level of expertise will be indicated.
Patients follow-up happens at D5, D15 and D28 through phone call. After verifying their identity using the initials entered and their date of birth, the patient or the referring person in the medical file is asked where the patient is currently (home, non ICU department, ICU department) and whether the patient is in respiratory assistance (invasive or not). In the event of notification of death, the date of occurrence will be indicated.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Association of pulmonary lesions on ultrasound on D0 classified according to three stages of severity
时间窗: at day 0
Association of pulmonary lesions on ultrasound on D0 classified according to three stages of severity * There are few B lines at the lung bases * Bi-lateralization of B lines, numerous diffuse and / or curtain sign * Presence of signs of pulmonary consolidation, hepatization of the lung and air bronchogram)
次要结局
- Measurement of survival(at day 28)
- Assessment of the agreement between a newly trained operator and an experienced operator of classification in one of the three stages of ultrasound gravity, by Cohen's kappa coefficient.(at day 0)
- Measurement of the cumulative incidence of invasive mechanical ventilation(at day 28)
- Estimate in patients who had a CT-scan on D0, the agreement in the evaluation of the severity of lung lesions via ultrasound vs. CT-scan, by Cohen's kappa coefficient(at day 0)
- Association of the worsening of pulmonary lesions with the ultrasound(just before discharge from hospital or in case of worsening)