Surgery and Lung Ultrasound in COVID-19 Infection (SOUNDS)

December 15, 2020 updated by: Fundacion Clinica Valle del Lili

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Anticipated)

451

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Colombia
    • Valle Del Cauca
      • Cali, Valle Del Cauca, Colombia, 76032
        • Recruiting
        • Fundacion Valle del Lili
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients who enter the Fundación Valle del Lili who require emergency surgery for any reason

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

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
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.
14 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
14 days
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.
14 days
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
14 days
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.
14 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fundacion Clinica Valle del Lili

Investigators

  • Principal Investigator: Alberto F. García, MDMSc, Fundacion Clinica Valle del Lili

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 8, 2020

Primary Completion (Anticipated)

July 31, 2021

Study Completion (Anticipated)

November 30, 2021

Study Registration Dates

First Submitted

December 7, 2020

First Submitted That Met QC Criteria

December 7, 2020

First Posted (Actual)

December 10, 2020

Study Record Updates

Last Update Posted (Actual)

December 17, 2020

Last Update Submitted That Met QC Criteria

December 15, 2020

Last Verified

May 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1601 (University Hospital Bern)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

The research information will be for the exclusive use of Fundación Valle del Lili

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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