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

NCT05544903 | Unknown

• 1 other identifier: 20-0151
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

Sepsis

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (2)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Emergency department patient
• + 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

You may not qualify if:

• Already intubated prior to emergency department arrival
• Ventilator-dependent
• Patients transferred from another hospital
• Pregnancy

Sponsors & Collaborators

• Northwell Health: lead
• Flosonics Medical: collaborator

Study Sites (1)

North Shore University Hospital

Manhasset, New York, 11030, United States

RECRUITING

MeSH Terms

Conditions

Sepsis

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Allison Cohen, MD

  North Shore University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Timmy Li, PhD

CONTACT

516-240-3933; tli2@northwell.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 9, 2022
• First Posted: September 19, 2022
• Study Start: September 1, 2022
• Primary Completion: September 1, 2024
• Study Completion: September 1, 2024
• Last Updated: October 13, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)