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

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

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.

Study Overview

• Status: Completed
• Conditions: Sepsis

• Study Type: Observational
• Enrollment (Actual): 134

Contacts and Locations

Study Locations

• United States
  • New York
    • Manhasset, New York, United States, 11030
      • North Shore University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients presenting to the emergency department who meet sepsis criteria based on presenting vital signs will be eligible for the study.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mortality	This study will ascertain whether the patient died within 24 hours of ED arrival.	24 hours
ICU admission	This study will ascertain whether the patient was admitted to the ICU within 24 hours of ED arrival.	24 hours
Rapid response team activation	This study will ascertain whether a rapid response team was activated for the patient within 24 hours of ED arrival.	24 hours

Collaborators and Investigators

• Sponsor: Northwell Health
• Collaborators: Flosonics Medical
• Investigators: Principal Investigator: Allison Cohen, MD, North Shore University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2022
• Primary Completion (Actual): December 18, 2023
• Study Completion (Actual): December 18, 2023

Study Registration Dates

• First Submitted: September 9, 2022
• First Submitted That Met QC Criteria: September 14, 2022
• First Posted (Actual): September 19, 2022

Study Record Updates

• Last Update Posted (Actual): June 15, 2026
• Last Update Submitted That Met QC Criteria: June 11, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathological Conditions, Signs and Symptoms; Sepsis
• Other Study ID Numbers: 20-0151

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No