跳至主要内容
临床试验/NCT04661631
NCT04661631Unknown不适用

Lung Ultrasound in COVID-19 Infection Screening for Patients With Indication of Emergency Surgery

Fundacion Clinica Valle del Lili1 个研究点 分布在 1 个国家目标入组 451 人开始时间: 2020年5月8日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
451
试验地点
1
主要终点
The best cut-off point for lung ultrasound to discriminate suspected cases of active SARS-CoV-2 infection

研究概览

简要总结

The first case of COVID-19 was identified on December 19 and the world is actually experiencing a pandemic. The surgical procedure in patients with SARS-CoV-2 infection involves the exposure of other patients and the group of health workers who face the care of the patient. Thus, screening with lung ultrasound is an alternative to identify patients with an established or suspected infection that requires urgent surgery. Therefore, the aim of this study is to determinate the operational characteristics of lung ultrasound during the screening process for SARS-CoV-2 infection in patients with an indication for urgent surgery.

详细描述

Surgical intervention of a COVID-19 patient involves the exposure of other patients and the group of health workers who face the care of the patient, which generates additional stress and a subsequent catastrophic respiratory and cardiovascular decompensation.

Managing a patient who is going to undergo a surgical procedure as he was infected, makes health care workers and other patients aware from the risk of infection by reinforcing precautions measures. However, it implies the waste of personal protective elements, and a subsequent chance of consuming the limited stocks of those elements.

Li, Y, et al., described transmission of COVID-19 in a thoracic surgery department. They were infected from a single patient, and from three-generation transmission eight more patients and eleven health care workers. 3 out of 9 patients were infected and none of the health care workers died.

Lei et al reported a case series of 34 patients undergoing surgical treatment during the incubation period of COVID-19. They all developed symptoms. 44% of the patients presented dyspnea in the following days and a third presented ARDS. Seven patients (21%) died.

In both reports it is clear that the failure to identify patients as COVID-19 infected patients prevented them from being managed with the proper precautions and preventive measures, and that health care workers did not use adequate personal protective elements. On the other hand, the reported outcome in both series was worse than the outcome in COVID-19 patients who did not required surgical treatment. This corresponds to anecdotal reports of cases in which manifestations occurred after surgery and did not have a favorable clinical course.

研究设计

研究类型
Observational
观察模型
Other
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

入选标准

  • Indication for surgery for any reason
  • Coming from the emergency room or hospitalized for less than 72 hours

排除标准

  • Chronic pulmonary disease
  • Heart failure
  • Kidney failure
  • Referred from another hospital with invasive mechanical ventilation

结局指标

主要结局

The best cut-off point for lung ultrasound to discriminate suspected cases of active SARS-CoV-2 infection

时间窗: 14 days

To identify the best cut-off point from lung ultrasound that allows the discrimination of suspected cases of active SARS-CoV-2 infection in patients undergoing an emergency surgical procedure since May 2020 at Fundación Valle del Lili Hospital, Cali, Colombia.

次要结局

  • Prevalence of active SARS-CoV-2 infection(14 days)
  • Operational characteristics of lung ultrasound(14 days)
  • Cut-off point resulting from the lung ultrasound score(14 days)
  • Operational characteristics of each of suspicious lung ultrasound findings(14 days)

研究者

发起方
Fundacion Clinica Valle del Lili
申办方类型
Other
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验