270 Participants Needed

ANNE One-Wellue Device for Vital Sign Monitoring

(ANNE One TMRCT Trial)

Recruiting at 1 trial location
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JS
Overseen ByJane S Kim, MS MEd
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Northwestern University
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if the ANNE One-Wellue Device Array, a wireless device, simplifies and speeds up vital sign checks for hospital patients. Researchers will compare this device to standard methods for measuring heart rate and blood pressure. The study includes patients admitted to a specific unit at Northwestern Memorial Hospital who can speak English and are not in isolation. As an unphased trial, it offers patients the chance to contribute to innovative research that could enhance hospital care.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that the ANNE One-Wellue Device is safe for vital sign monitoring?

Research has shown that the ANNE One-Wellue Device Array is safe for monitoring vital signs. The FDA has cleared the device, confirming it meets safety standards for medical use. Suitable for newborns, children, and adults, it is safe for all ages.

Wearable sensors in the device continuously track vital signs, reducing the need for frequent manual checks, which can be more disruptive. Although new in some areas, its use in continuous monitoring has shown promise, with few issues reported.

In summary, health authorities have approved the ANNE One-Wellue Device Array, confirming its safety and tolerance for users.12345

Why are researchers excited about this trial?

Researchers are excited about the ANNE One-Wellue Device because it offers a new way to monitor vital signs continuously and non-invasively. Unlike traditional methods that require periodic checks and manual input, this device array allows for real-time monitoring, potentially leading to quicker responses to changes in a patient's condition. This could improve patient care by reducing the time between vital sign changes and medical intervention.

What evidence suggests that the ANNE One-Wellue Device is effective for vital sign monitoring?

Research shows that the ANNE One-Wellue Device Array, which participants in this trial may use, speeds up the process of checking vital signs, such as heart rate and blood pressure. One study found that continuous monitoring with this device reduced the need for intensive care and lowered death rates. The device uses Bluetooth to send health data wirelessly, enabling healthcare providers to access vital sign information more quickly. Other research supports that remote monitoring systems effectively track health signs, allowing for quick responses to changes. Overall, early findings suggest that this technology can improve patient care by simplifying the collection of vital signs.16789

Who Is on the Research Team?

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Gregory (Randy) R Smith Jr, MD MS

Principal Investigator

Northwestern University Feinberg School of Medicine

Are You a Good Fit for This Trial?

This trial is for healthcare staff on a general medical floor who regularly measure and chart patients' vital signs. It's designed to see if using a wireless Bluetooth device array changes the time they spend on these tasks.

Inclusion Criteria

Inpatients admitted to Northwestern Memorial Hospital, Feinberg Unit 16 West.

Exclusion Criteria

Under isolation status
Primary language other than English
Pregnant patients
See 2 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 week

Treatment

Participants are monitored for time spent obtaining and charting vital signs using either routine methods or the ANNE One device array

3 days
Daily monitoring

Follow-up

Participants' sleep quality and satisfaction are assessed post-discharge

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • ANNE One-Wellue Device Array
Trial Overview The study is testing whether a new wireless Bluetooth vital sign array (ANNE One-Wellue) can make checking and recording patient vitals more efficient compared to the usual method. Staff are randomly chosen to use either the new device or continue with routine procedures.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Active Control
Group I: Intervention--Device Array UseExperimental Treatment1 Intervention
Group II: Control--Routine Vital Sign ObtainmentActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Northwestern University

Lead Sponsor

Trials
1,674
Recruited
989,000+

University of Minnesota Medical School/University of Minnesota Foundation

Collaborator

Trials
1
Recruited
20+

Sibel Health Inc.

Industry Sponsor

Trials
5
Recruited
380+

Citations

ANNE One-Wellue Device for Vital Sign MonitoringTrial Overview The study is testing whether a new wireless Bluetooth vital sign array (ANNE One-Wellue) can make checking and recording patient vitals more ...
Impact on Patient Outcomes of Continuous Vital Sign ...A recent propensity-matched study of primary surgical patients found decreased odds of intensive care unit (ICU) admission and mortality in patients receiving ...
(PDF) Automated Remote Pulse Oximetry System (ARPOS)Monitoring health remotely, specifically vital signs, has been a topic of interest for researchers, and the ARPOS system has been validated for various factors, ...
A smart all-in-one device to measure vital signs in admitted ...The Checkme, a smart all-in-one device capable of measuring vital signs, could improve daily patient monitoring by reducing measurement time.
5... data":[{"rel":"stylesheet","media":"all","href":"\/sites\/default\/files ... ANNE One-Wellue Device Array Use on Staff Bedside Vital Sign Measurement ...
ANNE One wireless monitoring platform receives new FDA ...The platform has now received clearance as a clinical-grade, continuous wireless monitoring solution for neonates, infants and adults.
Continuous Monitoring of Vital Signs Using Wearable ...Both VM and HP are promising for continuously monitoring vital signs in hospitalized patients, if the frequency and duration of artifacts are reduced.
Clinical CareANNE® View is an FDA-cleared solution that leverages advanced wearable sensors to provide comprehensive continuous monitoring. ANNE-One_Reddot ...
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