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

Sepsis Clinical Trial

— POCUS Sepsis  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05544903
• Other study ID #: 20-0151
• Status: Recruiting
• Start date: September 1, 2022
• Est. completion date: September 2024

Study information

• Verified date: October 2023
• Source: Northwell Health
• Contact: Timmy Li, PhD
• Phone: 516-240-3933
• Email: tli2[@]northwell.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: September 2024
• Est. primary completion date: September 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Emergencies
• Sepsis
• Toxemia

Locations

Country	Name	City	State
United States	North Shore University Hospital	Manhasset	New York

Sponsors (2)

Lead Sponsor	Collaborator
Northwell Health	Flosonics Medical

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mortality	This study will ascertain whether the patient died within 24 hours of ED arrival.	24 hours
Primary	ICU admission	This study will ascertain whether the patient was admitted to the ICU within 24 hours of ED arrival.	24 hours
Primary	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