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Surgery and Lung Ultrasound in COVID-19 Infection

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04661631
Acronym
SOUNDS
Enrollment
451
Registered
2020-12-10
Start date
2020-05-08
Completion date
2021-11-30
Last updated
2020-12-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

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.

Interventions

DIAGNOSTIC_TESTLung ultrasound

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

Sponsors

Fundacion Clinica Valle del Lili
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
The best cut-off point for lung ultrasound to discriminate suspected cases of active SARS-CoV-2 infection14 daysTo 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.

Secondary

MeasureTime frameDescription
Prevalence of active SARS-CoV-2 infection14 daysIdentify the prevalence of active SARS-CoV-2 infection in the group of patients undergoing an emergency surgical procedure.
Operational characteristics of lung ultrasound14 daysCalculate 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 findings14 daysCalculate 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 score14 daysIdentify the cut-off point resulting from the lung ultrasound score that discriminates between patients with suspected active SARS-CoV-2 infection.

Countries

Colombia

Contacts

Primary ContactAlberto F. García, MDMSc
afgm22016@gmail.com+ 57 (2) 3319090

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026