Hospital Based Continuous Patient Monitoring System

NCT ID: NCT06739447

Last Updated: 2026-01-23

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 250 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-03-15
• Study Completion Date: 2030-01-31

Brief 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

Trauma; Appendectomy; Pediatric ALL; Vital Signs Monitoring

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Consumer Wearable Device Measurement

Consumer wearable devices (CWD)

Group Type: EXPERIMENTAL

Consumer Wearable Device Vital Sign Measurement

Intervention Type: OTHER

Consumer Wearable Devices such as the Fitbit, are durable devices that can provide vital sign data.

Interventions

Consumer Wearable Device Vital Sign Measurement

Consumer Wearable Devices such as the Fitbit, are durable devices that can provide vital sign data.

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 3 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Northwestern University

OTHER

Sponsor Role: collaborator

University of Chicago

OTHER

Sponsor Role: collaborator

Ann & Robert H Lurie Children's Hospital of Chicago

OTHER

Sponsor Role: collaborator

University of Ghana

OTHER

Sponsor Role: collaborator

Loyola University

OTHER

Sponsor Role: collaborator

University of Alabama at Birmingham

OTHER

Sponsor Role: lead

Responsible Party

Hassan Ghomrawi

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Hassan Ghomrawi, PhD

Role: CONTACT

ghomrawi@uab.edu

205-930-7781

Other Identifiers

IRB-300013798

Identifier Type: -

Identifier Source: org_study_id