Respiratory Failure Clinical Trial
— CLUSCOOfficial title:
Prognostic Value of Point of Care Cardiac and Lung Ultrasound in COVID-19
NCT number | NCT04379544 |
Other study ID # | 843008 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | April 23, 2020 |
Est. completion date | December 1, 2021 |
Verified date | September 2023 |
Source | University of Pennsylvania |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational [Patient Registry] |
This is a protocol-driven observational study of lung ultrasound and focused echocardiography images obtained in the Emergency Department (ED) and Intensive Care Unit (ICU) settings as a part of existing standard of care. The objectives of this study are as follows: 1. To characterize various clinical and cardiopulmonary ultrasound findings and describe their relationship with the clinical course of patients with COVID-19 in the ED and ICU. 2. To describe, develop, and validate a prediction tool that can accurately predict the need for invasive mechanical ventilation (IMV) and acute respiratory failure in COVID-19 patients using clinical, laboratory, and ultrasound data.
Status | Completed |
Enrollment | 125 |
Est. completion date | December 1, 2021 |
Est. primary completion date | September 1, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 100 Years |
Eligibility | Inclusion Criteria: - COVID-19 positive or suspected positive - Received a cardiopulmonary ultrasound scan Exclusion Criteria: - Did not receive a scan - Not COVID-19 positive |
Country | Name | City | State |
---|---|---|---|
United States | University of Pennsylvania Health System | Philadelphia | Pennsylvania |
Lead Sponsor | Collaborator |
---|---|
University of Pennsylvania |
United States,
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* Note: There are 15 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Patient requires invasive mechanical ventilation and suffers from acute respiratory failure. | Number of patients requiring invasive mechanical ventilation and suffers from acute respiratory failure. | 1 Year | |
Primary | Patient is discharged | Number of patients that do not require hospitalization and is able to safely recover from COVID-19 at home. | 1 Year | |
Primary | Patient is hospitalized, but does not require mechanical ventilation through the duration of hospital stay. | Number of patients that must be hospitalized to recover from COVID-19, but does not require invasive mechanical ventilation and may or may not suffer from some degree of acute respiratory failure. | 1 Year | |
Secondary | Lung ultrasound findings | Any lung ultrasound findings including, but not limited to b-lines, a-lines, consolidations, pleural effusions and regularities. All of these findings are consolidated to a single score which will be the measure of the severity of lung ultrasound findings. | 1 year | |
Secondary | Cardiac ultrasound findings | Any cardiac ultrasound findings including, but not limited to IVC status, pericardial effusions, LV EF (%), RV function. All of these findings are consolidated to a single score which will be the measure of the severity of cardiac ultrasound findings. | 1 year |
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