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

NCT ID: NCT05544903

Last Updated: 2023-10-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

150 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-09-01

Study Completion Date

2024-09-30

Brief Summary

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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.

Detailed Description

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Conditions

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Sepsis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Mortality, ICU admission, or rapid response team activation

Carotid flow patterns and velocity time integral values, as determined by FloPatch.

No interventions assigned to this group

No mortality, ICU admission, or rapid response team activation

Carotid flow patterns and velocity time integral values, as determined by FloPatch.

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Flosonics Medical

UNKNOWN

Sponsor Role collaborator

Northwell Health

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Allison Cohen, MD

Role: PRINCIPAL_INVESTIGATOR

North Shore University Hospital

Locations

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North Shore University Hospital

Manhasset, New York, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Timmy Li, PhD

Role: CONTACT

516-240-3933

Facility Contacts

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Timmy Li, PhD

Role: primary

516-240-3933

Other Identifiers

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20-0151

Identifier Type: -

Identifier Source: org_study_id

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