POCUS Sepsis: Point of Care Ultrasound to Predict Intensive Care Unit Admission of Patients Presenting With Sepsis to the Emergency Department

Sponsor
Northwell Health (Other)
Overall Status
Recruiting
CT.gov ID
NCT05544903
Collaborator
Flosonics Medical (Other)
150
1
12
12.5

Study Details

Study Description

Brief Summary

The FloPatch device will be applied to 150 septic patients in the emergency department before they receive fluid resuscitation. This study will assess whether initial FloPatch measured volume-responsiveness and volume of fluids used will predict a composite outcome of mortality, intensive care unit admission, or rapid response team activation. The development of fluid unresponsiveness throughout the initial fluid resuscitation will be assessed and its association with the composite outcome will be assessed.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    150 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    The Use of Point of Care Ultrasound to Predict Intensive Care Unit Admission of Patients Presenting With Sepsis to the Emergency Department
    Actual Study Start Date :
    Sep 1, 2022
    Anticipated Primary Completion Date :
    Sep 1, 2023
    Anticipated Study Completion Date :
    Sep 1, 2023

    Arms and Interventions

    Arm Intervention/Treatment
    Mortality, ICU admission, or rapid response team activation

    Carotid flow patterns and velocity time integral values, as determined by FloPatch.

    No mortality, ICU admission, or rapid response team activation

    Carotid flow patterns and velocity time integral values, as determined by FloPatch.

    Outcome Measures

    Primary Outcome Measures

    1. Mortality [24 hours]

      This study will ascertain whether the patient died within 24 hours of ED arrival.

    2. ICU admission [24 hours]

      This study will ascertain whether the patient was admitted to the ICU within 24 hours of ED arrival.

    3. Rapid response team activation [24 hours]

      This study will ascertain whether a rapid response team was activated for the patient within 24 hours of ED arrival.

    Eligibility Criteria

    Criteria

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

    • 18+ years old

    • Systolic blood pressure less than 100mmHg

    • Respiratory rate greater than 22 breaths per minutes

    • Temperature greater than 38 degrees Celsius or less than 36 degrees Celsius

    • Heart rate greater than 90 beats per minute

    Exclusion Criteria:
    • Already intubated prior to emergency department arrival

    • Ventilator-dependent

    • Patients transferred from another hospital

    • Pregnancy

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 North Shore University Hospital Manhasset New York United States 11030

    Sponsors and Collaborators

    • Northwell Health
    • Flosonics Medical

    Investigators

    • Principal Investigator: Allison Cohen, MD, North Shore University Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Northwell Health
    ClinicalTrials.gov Identifier:
    NCT05544903
    Other Study ID Numbers:
    • 20-0151
    First Posted:
    Sep 19, 2022
    Last Update Posted:
    Sep 19, 2022
    Last Verified:
    Sep 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Sep 19, 2022