跳至主要内容
临床试验/NCT04433000
NCT04433000Unknown不适用

Comparison Between a Pocket Sized and a High End Ultrasound Scanner in the Evaluation of Lung Involvement in Patients With Covid-19 Pneumonia

University of Siena1 个研究点 分布在 1 个国家目标入组 34 人开始时间: 2020年3月15日最近更新:
适应症

试验速览

阶段
不适用
入组人数
34
试验地点
1
主要终点
Bland-Altman estimate of bias and Limits of Agreement (LoA) of patient mean scores obtained with the two instruments

研究概览

简要总结

Ultrasound imaging of the lung (LUS) and associated tissues has demonstrated clinical utility in COVID-19 patients. The aim of the present study was to evaluate the possibilities of a portable pocket-sized ultrasound scanner in the evaluation of lung involvement in patients with COVID-19 pneumonia, in comparison with a high end ultrasound scanner.

Statisical analysis will be performed with Stata for Windows V 16 (Stata corp, Texas College, TX). Power size estimation using Medcalc 19.3.1, (MedCalc Software Ltd, Ostenda, B) showed that hat 34 patients would be required for the comparison of the two methods using the Bland-Altman method assuming a mean difference in total score of 1±1, a false positive rate (α) of 0.05 and a false negative rate of 0.1 (β=0.9).

详细描述

Coronavirus disease 2019 (COVID-19), caused by infection with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), emerged in China in December 2019 and quickly spread all over the globe. The clinical features are fever, dyspnoea, dry cough, fatigue and diarrhoea (1). Pharyngodynia, nasal congestion, rhinorrhoea and anosmia have also been reported . Interstitial pneumonia is very common and a high percentage of patients (9-11%) develop severe acute respiratory distress syndrome (ARDS) and require intensive care. Current therapeutic strategy involves agents counteracting viral invasion and replication, and inhibitors of cytokine-sustained inflammatory reactions. No specific antiviral therapy has yet been identified.

Ultrasound imaging of the lung (LUS) and associated tissues has demonstrated clinical utility in COVID-19 patients, due to the typical sonographic characteristics of affected lungs. It provides indications for clinical decisions and the management of associated respiratory failure and lung injury.

The aim of the present study was to evaluate the possibilities of a portable pocket-sized ultrasound scanner in the evaluation of lung involvement in patients with COVID-19 pneumonia.

We will perform 34 LUS (lung ultrasound scan) evaluations on patients admitted to the COVID Unit of Siena University Hospital with symptoms compatible with COVID-19, a positive SARS-CoV-2 nasal-pharyngeal swab and radiological evidence of interstitial pneumonia.

The patients will be divided into three severity categories based on respiratory impairment: Mild PaO2/FiO2 > 300 in room air or oxygen flow; Moderate PaO2/FiO2 between 150 and 300 in room air or oxygen-therapy, CPAP, NIV or HFNC; Severe PaO2/FiO2 < 150 on oxygen-therapy, CPAP, NIV, HFNC or mechanical ventilation.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Retrospective

入排标准

性别
All
接受健康志愿者

入选标准

  • Admitted to hospital ward with a diagnosis of Covid-19 preumonia, confirmed by a positive rtPCR swab and radiography

排除标准

  • Unable/unwilling to cooperate

结局指标

主要结局

Bland-Altman estimate of bias and Limits of Agreement (LoA) of patient mean scores obtained with the two instruments

时间窗: 1 day

The more widely accepted measure of agreement beteen two instruments. Bland JM, Altman DG (1986) Statistical method for assessing agreement between two methods of clinical measurement. The Lancet i:307-310

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Piersante Sestini

Associate professor of respiratory diseases

University of Siena

研究点 (1)

Loading locations...

相似试验