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Ultrasound patch could help ER doctors spot sepsis patients needing ICU care

NCT ID NCT05544903

Knowledge-focused Sponsor: Northwell Health Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tested whether a small ultrasound patch called FloPatch can help emergency doctors predict which sepsis patients will need intensive care. The device measures how well the heart responds to fluids. Researchers followed 134 patients to see if FloPatch readings could predict death, ICU admission, or the need for a rapid response team within 24 hours. If it works, this tool could help doctors make faster, more accurate treatment decisions for sepsis patients.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
FloPatch (point-of-care ultrasound device)
What this could lead to
If successful, this could give emergency doctors a quick, non-invasive tool to identify sepsis patients who need intensive care, potentially improving outcomes and resource use.
What could go wrong
This is a small, completed observational study (134 patients) that only looks at predictions within 24 hours. The device may not work as well in larger, more diverse groups or in different hospital settings.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

134 people

The number who actually took part.

Started

Sep 2022

Finished

Dec 2023

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

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

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

infectious disease with sepsis Sepsis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Sepsis

Contacts and locations

Locations

  • North Shore University Hospital

    Manhasset, New York, 11030, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.