Surgery and Lung Ultrasound in COVID-19 Infection

Covid19 Clinical Trial

— SOUNDS  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04661631
• Other study ID #: 1601
• Status: Recruiting
• Start date: May 8, 2020
• Est. completion date: November 30, 2021

Study information

• Verified date: May 2020
• Source: Fundacion Clinica Valle del Lili
• Contact: Alberto F. García, MDMSc
• Phone: + 57 (2) 3319090
• Email: afgm22016[@]gmail.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 451
• Est. completion date: November 30, 2021
• Est. primary completion date: July 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Coronavirus Infections
• Covid19
• Lung Diseases
• Severe Acute Respiratory Syndrome
• Severe Acute Respiratory Syndrome Coronavirus 2
• Surgical Procedure
• Ultrasonography

Intervention

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

Locations

Country	Name	City	State
Colombia	Fundación Valle del Lili	Cali	Valle Del Cauca

Sponsors (1)

Lead Sponsor	Collaborator
Fundacion Clinica Valle del Lili

Country where clinical trial is conducted

Colombia, 

References & Publications (31)

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* Note: There are 31 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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