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OpenTrials
Completed

NCT Number: NCT05544903

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

North Shore University Hospital

Manhasset, New York, 11030, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Mortality

    Time frame: 24 hours

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

  2. ICU admission

    Time frame: 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

    Time frame: 24 hours

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

Sponsors and collaborators

Lead sponsor

Northwell Health

Other

Collaborators

  • Flosonics Medical

Registry information

Official study title

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

Acronym: POCUS Sepsis

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Sep 19, 2022
Registry last updated
Jun 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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