Surgery and Lung Ultrasound in COVID-19 Infection (SOUNDS)
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|ClinicalTrials.gov Identifier: NCT04661631|
Recruitment Status : Recruiting
First Posted : December 10, 2020
Last Update Posted : December 17, 2020
|Condition or disease||Intervention/treatment|
|Ultrasonography Lung Diseases Surgical Procedure Covid19 Severe Acute Respiratory Syndrome Coronavirus 2||Diagnostic Test: Lung ultrasound|
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.
|Study Type :||Observational [Patient Registry]|
|Estimated Enrollment :||451 participants|
|Target Follow-Up Duration:||14 Days|
|Official Title:||Lung Ultrasound in COVID-19 Infection Screening for Patients With Indication of Emergency Surgery|
|Actual Study Start Date :||May 8, 2020|
|Estimated Primary Completion Date :||July 31, 2021|
|Estimated Study Completion Date :||November 30, 2021|
- Diagnostic Test: Lung ultrasound
Lung ultrasound during the screening process for SARS-CoV-2 infection in patients with an indication for urgent surgery.
- The best cut-off point for lung ultrasound to discriminate suspected cases of active SARS-CoV-2 infection [ Time Frame: 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.
- Prevalence of active SARS-CoV-2 infection [ Time Frame: 14 days ]Identify the prevalence of active SARS-CoV-2 infection in the group of patients undergoing an emergency surgical procedure.
- Operational characteristics of lung ultrasound [ Time Frame: 14 days ]Calculate the operational characteristics of lung ultrasound for the diagnosis of SARS-CoV-2 infection in the studied group of patients.
- Operational characteristics of each of suspicious lung ultrasound findings [ Time Frame: 14 days ]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
- Cut-off point resulting from the lung ultrasound score [ Time Frame: 14 days ]Identify the cut-off point resulting from the lung ultrasound score that discriminates between patients with suspected active SARS-CoV-2 infection.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04661631
|Contact: Alberto F. García, MDMSc||+ 57 (2) 3319090 ext email@example.com|
|Fundación Valle del Lili||Recruiting|
|Cali, Valle Del Cauca, Colombia, 76032|
|Contact: Sergio I. Prada, MPA PhD +57 (2) 3319090 ext 4022 firstname.lastname@example.org|
|Principal Investigator:||Alberto F. García, MDMSc||Fundacion Clinica Valle del Lili|