Surgery and Lung Ultrasound in COVID-19 Infection

NCT04661631 | Unknown DMC

• 1 other identifier: 1601
• Study Type: observational
• Target: 451
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Prevalence of active SARS-CoV-2 infection

  14 days

• Operational characteristics of lung ultrasound

  14 days

• Operational characteristics of each of suspicious lung ultrasound findings

  14 days

• Cut-off point resulting from the lung ultrasound score

  14 days

Interventions

Lung ultrasound DIAGNOSTIC_TEST

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• Indication for surgery for any reason
• Coming from the emergency room or hospitalized for less than 72 hours

You may not qualify if:

• Prisoner
• Chronic pulmonary disease
• Heart failure
• Kidney failure
• Referred from another hospital with invasive mechanical ventilation

Sponsors & Collaborators

• Fundacion Clinica Valle del Lili: lead

Study Sites (1)

Fundación Valle del Lili

Cali, Valle del Cauca Department, 76032, Colombia

RECRUITING

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MeSH Terms

Conditions

Lung Diseases; COVID-19

Condition Hierarchy (Ancestors)

Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections

Study Officials

• Alberto F. García, MDMSc

  Fundacion Clinica Valle del Lili

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Alberto F. García, MDMSc

CONTACT

+ 57 (2) 3319090; afgm22016@gmail.com

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Target Duration: 14 Days
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 7, 2020
• First Posted: December 10, 2020
• Study Start: May 8, 2020
• Primary Completion: July 31, 2021
• Study Completion: November 30, 2021
• Last Updated: December 17, 2020

Record last verified: 2020-05

Data Sharing

• IPD Sharing: Will not share

Locations

CO (1)