Surgery and Lung Ultrasound in COVID-19 Infection

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Ultrasonography, Lung Diseases, Surgical Procedure, Covid19, Severe Acute Respiratory Syndrome Coronavirus 2

Intervention / Treatment
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* Diagnostic Test: Lung ultrasound


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Diagnostic Test: Lung ultrasound|Lung ultrasound during the screening process for SARS-CoV-2 infection in patients with an indication for urgent surgery.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The best cut-off point for lung ultrasound to discriminate suspected cases of active SARS-CoV-2 infection | 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. | 14 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prevalence of active SARS-CoV-2 infection | Identify the prevalence of active SARS-CoV-2 infection in the group of patients undergoing an emergency surgical procedure. | 14 days | 
| Operational characteristics of lung ultrasound | Calculate the operational characteristics of lung ultrasound for the diagnosis of SARS-CoV-2 infection in the studied group of patients. | 14 days | 
| Operational characteristics of each of suspicious lung ultrasound findings | Calculate the operational characteristics of each of suspicious lung ultrasound findings for the diagnosis of SARS-CoV-2 infection in the group of patients studied | 14 days | 
| Cut-off point resulting from the lung ultrasound score | Identify the cut-off point resulting from the lung ultrasound score that discriminates between patients with suspected active SARS-CoV-2 infection. | 14 days |