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Point-of-care Lung Ultrasound (POCUS)-Integrated Study of Admitted Patients With COVID-19 (PIOS-COVID)

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ClinicalTrials.gov Identifier: NCT05228717
Recruitment Status : Recruiting
First Posted : February 8, 2022
Last Update Posted : April 29, 2022
Sponsor:
Information provided by (Responsible Party):
Olive View-UCLA Education & Research Institute

Brief Summary:
This study seeks to define the ultrasound profile of patients with COVID-19, and document the progression of these ultrasound findings to develop prognostication and clinical decision instruments that can help guide management of patient with COVID-19. Primary aims include the development of ARDS, refractory hypoxemia, acute cardiac injury, pulmonary embolism, pneumothorax or death. Secondary aims include potential change in CT and plain film utilization given the use of POCUS, as well as emergency department and inpatient LOS (length of stay).

Condition or disease Intervention/treatment
Lung Injury ARDS Acute Cardiac Event Covid19 Ultrasound Hypoxemia Acute Respiratory Distress Syndrome Diagnostic Test: Point of Care Ultrasound

Detailed Description:

A. SPECIFIC AIMS

  1. To define the lung ultrasound profile of patients admitted with COVID-19 pneumonia, hypoxia, or hypoxemic respiratory failure.
  2. To document the progression of POCUS findings in admitted patients with COVID-19 respiratory failure.
  3. Along with other clinical data, to develop a prognostication and clinical decision instrument that can help guide management of patients with COVID-19, specifically for the following specific outcomes:

    • Development of ARDS, worsening oxygen requirement, or need for intubation. On POCUS, this would be associated with a shift in lateral lung involvement to anterior lung zone involvement; or overall increase in B-lines for all lung zones
    • Refractory hypoxemia requiring lung recruitment maneuvers, including prone positioning or ECMO (extra-corporeal membrane oxygenation). On POCUS, this would be associated with the presence of posterior-lateral alveolar consolidation, which gives the appearance of "hepatization of lung"
    • Development of acute cardiac injury, as defined by acute coronary syndrome or myocarditis. On POCUS, this would be associated with the development of worsening systolic function
    • Development of pulmonary embolism as defined by CT evidence, +DVT (deep vein thrombosis), or therapeutic anticoagulation. On POCUS, this would be associated with a RV (right ventricle) strain pattern (D-shaped septum on parasternal short axis, RV>LV (left ventricle) diameter on apical)
    • Development of pneumothorax. On POCUS, this would be associated with the absence of pleural sliding

    A composite outcome of development of ARDS, acute cardiac injury, hypoxemic respiratory failure requiring prone positioning or ECMO, PE (pulmonary embolism), PTX (pneumothorax), or death, will be used as the primary outcome.

    These are secondary aims that investigators will assess, but not base our power calculation on:

  4. To assess the potential change of using POCUS in CT and plain film utilization, as well as emergency department and inpatient LOS.
  5. If current triage workflow related to the COVID-19 pandemic integrates POCUS into triage, investigators will extend this analysis to the point of triage, and not just admitted patients.
  6. To assess the prevalence of lung ultrasound findings suggestive of COVID-19 infection in patients that present with acute coronary syndromes.

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Study Type : Observational
Estimated Enrollment : 240 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Point-of-care Lung Ultrasound (POCUS)-Integrated Observation Study of Admitted Patients With COVID-19
Actual Study Start Date : November 10, 2020
Estimated Primary Completion Date : June 2022
Estimated Study Completion Date : June 2022


Group/Cohort Intervention/treatment
COVID+

Patients with confirmed COVID-19 pneumonia as the primary diagnosis, or COVID-associated acute hypoxemic respiratory failure or hypoxia (minimum O2 requirement 3L), that are being admitted from the emergency department, who either have waiver of consent, give verbal consent to participate, or have NOK (next of kin) provide consent.

Exclusion criteria: age <18 years old, pregnant patients, or patients that verbally refuse participation Intervention/observation: q48-72h POCUS of the lungs, heart, and IVC

Diagnostic Test: Point of Care Ultrasound
q48-72h point of care ultrasound of the lungs, heart, and IVC (inferior vena cava)




Primary Outcome Measures :
  1. Association of POCUS changes with major clinical events [ Time Frame: From admission to 21 days, or endpoint reached ]
    Association of POCUS worsening with development of a composite outcome of development of ARDS, acute cardiac injury, hypoxemic respiratory failure requiring prone positioning or ECMO, pneumothorax, cardiac tamponade, or death.

  2. Time from POCUS worsening to clinical diagnosis. [ Time Frame: From admission to 21 days, or endpoint reached ]
    Time interval from POCUS worsening to clinical diagnosis. Investigators will measure the duration between POCUS worsening and clinical diagnosis of any of the major clinical events described in outcome 1.


Secondary Outcome Measures :
  1. Utilization of traditional radiography [ Time Frame: From admission to 21 days, or endpoint reached ]
    To assess the potential change of using POCUS in CT and plain film utilization, as well as emergency department and inpatient LOS.

  2. Individual clinical outcomes [ Time Frame: From admission to 21 days, or endpoint reached ]
    Investigators will compare POCUS changes and the time interval to development of each of the following outcomes: ARDS, acute cardiac injury, hypoxemic respiratory failure requiring prone positioning or ECMO, pneumothorax, cardiac tamponade, or death.



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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:   Non-Probability Sample
Study Population
Inpatients with COVID-19 Pneumonia/hypoxemic respiratory failure requiring at least 3L of O2.
Criteria

Inclusion Criteria:

  • Patients with confirmed COVID-19 pneumonia as the primary diagnosis, or COVID- associated acute hypoxemic respiratory failure or hypoxia (minimum O2 requirement 3L), that are being admitted from the emergency department, who either have waiver of consent, give verbal consent to participate, or have next of kin give consent for participation.

Exclusion Criteria:

  • age < 18 years old, pregnant patients, or patients that verbally refuse participation

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): NCT05228717


Contacts
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Contact: James Murphy, MD 7472103107 jjmurphy@mednet.ucla.edu
Contact: Alan Chiem, MD 7472103107 achiem@mednet.ucla.edu

Locations
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United States, California
UCLA-Ronald Reagan Recruiting
Los Angeles, California, United States, 90095
Contact: James Murphy, MD    310-794-0785    jjmurphy@mednet.ucla.edu   
Contact: George Lim, MD    3107940785    gwlim@mednet.ucla.edu   
Olive View-UCLA Recruiting
Sylmar, California, United States, 91342
Contact: Alan Chiem, MD MPH    747-210-3107    achiem@mednet.ucla.edu   
United States, New York
SUNY Downstate Recruiting
New York, New York, United States, 11203
Contact: Ian DeSouza, MD       ian.desouza@downstate.edu   
United States, Pennsylvania
Temple University Recruiting
Philadelphia, Pennsylvania, United States, 19140
Contact: Ryan Gibbons, MD       ryan.gibbons@tuhs.temple.edu   
Sponsors and Collaborators
Olive View-UCLA Education & Research Institute
Publications:
Pan F, Ye T, Sun P, et al. Time Course of Lung Changes On Chest CT During Recovery From 2019 Novel Coronavirus (COVID-19) Pneumonia. Radiology. 2020 Feb 13:200370. doi: 10.1148/radiol.2020200370. [Epub ahead of print].

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Responsible Party: Olive View-UCLA Education & Research Institute
ClinicalTrials.gov Identifier: NCT05228717    
Other Study ID Numbers: 1590419
First Posted: February 8, 2022    Key Record Dates
Last Update Posted: April 29, 2022
Last Verified: April 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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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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COVID-19
Respiratory Distress Syndrome
Respiratory Distress Syndrome, Newborn
Acute Lung Injury
Lung Injury
Hypoxia
Respiratory Tract Infections
Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases
Respiration Disorders
Infant, Premature, Diseases
Infant, Newborn, Diseases
Thoracic Injuries
Wounds and Injuries
Signs and Symptoms, Respiratory