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Trials / Not Yet Recruiting

Not Yet RecruitingNCT06739447

Hospital Based Continuous Patient Monitoring System

Implementing a Hospital-based Continuous Patient Monitoring System Using Consumer Wearable Devices in Ghana

Status
Not Yet Recruiting
Phase
N/A
Study type
Interventional
Enrollment
250 (estimated)
Sponsor
University of Alabama at Birmingham · Academic / Other
Sex
All
Age
3 Years – 18 Years
Healthy volunteers
Not accepted

Summary

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.

Detailed 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.

Conditions

Interventions

TypeNameDescription
OTHERConsumer Wearable Device Vital Sign MeasurementConsumer Wearable Devices such as the Fitbit, are durable devices that can provide vital sign data.

Timeline

Start date
2026-04-30
Primary completion
2029-11-30
Completion
2030-01-01
First posted
2024-12-18
Last updated
2026-03-23

Source: ClinicalTrials.gov record NCT06739447. Inclusion in this directory is not an endorsement.