Clinical trial NCT04661631: Surgery and Lung Ultrasound in COVID-19 Infection
Official title: Lung Ultrasound in COVID-19 Infection Screening for Patients With Indication of Emergency Surgery
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Ultrasonography
Lung Diseases
Surgical Procedure
Covid19
Severe Acute Respiratory Syndrome Coronavirus 2
Lead sponsor: Fundacion Clinica Valle del Lili
Sponsor class: OTHER
First posted: 2020-12-10
Enrollment: 451
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients who enter the Fundación Valle del Lili who require emergency surgery for any reason

Brief summary: 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.

Detailed description: 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.

In addition to this, an exponential growth of the infection by the COVID-19 virus in Colombia and the large amount of unidentified contaminants, justifies the implementation of a system that allows the identification of patients with COVID-19 infection, with the purpose of a correct surgical management, isolation, and protection of health care workers and other patients.

Screening with lung ultrasound is an alternative to identify patients with an established or suspected infection that requires urgent surgery. Its diagnostic efficacy has not been well studied in a systematic way in the scientific literature. Its use has just been described in patients with established COVID-19 pneumonia. Therefore, a research study is proposed to determine the operational characteristics of lung ultrasound during the screening process of patients who are going to be operated urgently.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

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

Primary outcomes:
measure: The best cut-off point for lung ultrasound to discriminate suspected cases of active SARS-CoV-2 infection
timeFrame: 14 days
Secondary outcomes:
measure: Prevalence of active SARS-CoV-2 infection
timeFrame: 14 days
measure: Operational characteristics of lung ultrasound
timeFrame: 14 days
measure: Operational characteristics of each of suspicious lung ultrasound findings
timeFrame: 14 days
measure: Cut-off point resulting from the lung ultrasound score
timeFrame: 14 days
Other outcomes:
Locations:
city: Cali
country: Colombia
facility: Fundación Valle del Lili
state: Valle Del Cauca
Study officials:
affiliation: Fundacion Clinica Valle del Lili
name: Alberto F. García, MDMSc
role: PRINCIPAL_INVESTIGATOR
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