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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
Sponsor:
Information provided by (Responsible Party):
Fundacion Clinica Valle del Lili

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.

Condition or disease Intervention/treatment
Ultrasonography Lung Diseases Surgical Procedure Covid19 Severe Acute Respiratory Syndrome Coronavirus 2 Diagnostic Test: Lung ultrasound

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.

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 451 participants
Observational Model: Other
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ultrasound


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


Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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

  4. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients who enter the Fundación Valle del Lili who require emergency surgery for any reason
Criteria

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

Information from the National Library of Medicine

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


Contacts
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Contact: Alberto F. García, MDMSc + 57 (2) 3319090 ext 8201 afgm22016@gmail.com

Locations
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Colombia
Fundación Valle del Lili Recruiting
Cali, Valle Del Cauca, Colombia, 76032
Contact: Sergio I. Prada, MPA PhD    +57 (2) 3319090 ext 4022    sergio.prada@fvl.org.co   
Sponsors and Collaborators
Fundacion Clinica Valle del Lili
Investigators
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Principal Investigator: Alberto F. García, MDMSc Fundacion Clinica Valle del Lili
Publications of Results:

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Responsible Party: Fundacion Clinica Valle del Lili
ClinicalTrials.gov Identifier: NCT04661631    
Other Study ID Numbers: 1601
First Posted: December 10, 2020    Key Record Dates
Last Update Posted: December 17, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: The research information will be for the exclusive use of Fundación Valle del Lili

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Severe Acute Respiratory Syndrome
Lung Diseases
Respiratory Tract Diseases
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections