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Hospital Based Continuous Patient Monitoring System

The University of Alabama at Birmingham logo

The University of Alabama at Birmingham

Status

Begins enrollment in 1 month

Conditions

Trauma
Vital Signs Monitoring
Pediatric ALL
Appendectomy

Treatments

Other: Consumer Wearable Device Vital Sign Measurement

Study type

Interventional

Funder types

Other

Identifiers

NCT06739447
IRB-300013798

Details and patient eligibility

About

In Ghana, and many other low and middle income countries in Africa, manual vital signs monitoring is the prevalent mode of vital signs monitoring because continuous bedside monitors are non-functional. This lack of continuous vital signs monitoring may result in missed opportunities to catch physiologic deterioration.

The investigators propose to develop a dashboard that is based on the Garmin Venu 3, a consumer wearable device that reliably measures heart rate, SPO2, and respiratory rate, as an alternative to bedside monitors in hospitals in Ghana.

Full description

Vital sign (VS) monitoring is a universal tool used to assess patients' basic physiologic status, primarily to detect physiologic deterioration indicative of clinically meaningful events. Physiologic deterioration occurs relatively commonly in trauma and postoperative patient populations. In most high-income countries (HIC), such patients are therefore monitored by automated, continuous, bedside VS systems, while, in many low-and middle-income countries (LMIC), manual, intermittent (from every 15 minutes to every 6 hours) VS monitoring is still widely employed.

The investigators propose to further refine and scale up a CONsumer-grade wearable monitoring System to improve Outcomes in Low resource settings (CONSOL) in Ghana. CONSOL is a CWD based platform, developed by the MPIs, that collects and displays in near real time, HR, RR, and SpO2, with snapshots of the past 1 minute, and 1, 4, and 24 hours, viewable on an tabet or smartphone. The investigators propose to evaluate the use of CONSOL for VS monitoring of (a) pediatric trauma patients in the Emergency Department (ED) and (b) pediatric postoperative appendicitis patients on a surgical unit, given higher risk of physiologic deterioration indicative of clinically meaningful events in these patient populations, and because pediatric patients are often more limited, than adults, in their ability to communicate about signs and symptoms.

Enrollment

250 estimated patients

Sex

All

Ages

3 to 18 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Pediatric patients presenting with traumatic injury
  • Pediatric patients postoperative status after an appendectomy

Exclusion criteria

  • Pediatric patients missing their upper limbs,
  • Pediatric patients who cannot wear a Fitbit on their wrist for known allergies to rubber or those with traumatic or medical conditions that prevent them from being able to comfortably wear a Fitbit on either hand

Trial design

Primary purpose

Diagnostic

Allocation

Non-Randomized

Interventional model

Sequential Assignment

Masking

None (Open label)

250 participants in 1 patient group

Consumer Wearable Device Measurement
Experimental group
Description:
Consumer wearable devices (CWD)
Treatment:
Other: Consumer Wearable Device Vital Sign Measurement

Trial contacts and locations

0

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Central trial contact

Hassan Ghomrawi, PhD

Data sourced from clinicaltrials.gov

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