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COVID VOICE: Coronavirus: Ventilator Outcomes Using Artificial Intelligence Chest Radiographs & Other Evidence-based Co-variates

Sponsor
King's College Hospital NHS Trust (Other)
Overall Status
Recruiting
CT.gov ID
NCT04855539
Collaborator
King's College London (Other)
300
Enrollment
3
Locations
21
Anticipated Duration (Months)
100
Patients Per Site
4.8
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

We will determine ventilator outcomes to Coronavirus Infectious Disease 2019 (COVID-19) using artificial Intelligence with inputs of chest radiographs and other evidence-based co-variates.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    The chest radiograph (chest x-ray) has emerged as the United Kingdom's National Health Service (NHS) frontline diagnostic imaging test for COVID-19, in conjunction with clinical history and key blood markers: C-reactive protein (CRP) and lymphopenia. Typically, every suspected COVID-19 patient presenting to the emergency department is undergoing blood tests and a chest radiograph. Therefore, it has become critical for radiologists to review and "hot" report the chest x-ray urgently.

    Primary Objective: Use chest radiographs and clinical data to determine whether patient can survive with a ventilator

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    300 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Coronavirus Infectious Disease 2019: Ventilator Outcomes Using Artificial Intelligence, Chest Radiographs and Other Evidence-based Co-variates (COVID VOICE)
    Actual Study Start Date :
    Mar 1, 2020
    Actual Primary Completion Date :
    May 1, 2021
    Anticipated Study Completion Date :
    Dec 1, 2021

    Arms and Interventions

    Arm Intervention/Treatment
    wave 1
    wave 2

    Outcome Measures

    Primary Outcome Measures

    1. Sensitivity and specificity of a convolutional neural network to predict survival outcome [1 month]

      Defined by sensitivity, specificity, positive and negative predictive values

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    Admitted to intensive care unit (ITU) or equivalent COVID-19 polymerase chain reaction (PCR) positive

    Exclusion Criteria:

    No imaging prior to ITU admission

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Princess Royal University Hospital Orpington Kent United Kingdom
    2 Guy's and St Thomas' Hospital London United Kingdom
    3 King's College Hospital London United Kingdom

    Sponsors and Collaborators

    • King's College Hospital NHS Trust
    • King's College London

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    King's College Hospital NHS Trust
    ClinicalTrials.gov Identifier:
    NCT04855539
    Other Study ID Numbers:
    • IRAS 232823
    First Posted:
    Apr 22, 2021
    Last Update Posted:
    Sep 16, 2021
    Last Verified:
    Sep 1, 2021
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Pneumonia

    Study Results

    No Results Posted as of Sep 16, 2021