Hospital Based Continuous Patient Monitoring System

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Trauma; Pediatric ALL; Appendectomy; Vital Signs Monitoring
• Intervention / Treatment: Other: Consumer Wearable Device Vital Sign Measurement

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.

• Study Type: Interventional
• Enrollment (Estimated): 250
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Hassan Ghomrawi, PhD; Phone Number: 205-930-7781; Email: ghomrawi@uab.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Non-Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Consumer Wearable Device Measurement; Consumer wearable devices (CWD)	Other: Consumer Wearable Device Vital Sign Measurement; Consumer Wearable Devices such as the Fitbit, are durable devices that can provide vital sign data.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in heart rate with CONSOL compared to pre-CONSOL implementation	The investigators will implement CONSOL and record the abnormal vital signs indicative of clinically meaningful events in the CONSOL group. The investigators will then compare the number of abnormal vital signs detected in the CONSOL group to that of the group of patient before CONSOL is implemented. The investigators will match the 2 groups on time period (e.g., CONSOL group recruited in 6-month period with pre-CONSOL group in the 6 months prior CONSOL. Vital sign measured is heart rate. Abnormal vital sign cutoffs are listed below: Heart Rate (beats/minute) 1-4 years old < 60 or >120 5-12 years old <60 or >110 13-18 years old <60 or >100	During the intervention (vital sign monitoring using the Garmin Venu 3)
Change in respiratory rate with CONSOL compared to pre-CONSOL implementation	The investigators will implement CONSOL and record the abnormal vital signs indicative of clinically meaningful events in the CONSOL group. The investigators will then compare the number of abnormal vital signs detected in the CONSOL group to that of the group of patient before CONSOL is implemented. The investigators will match the 2 groups on time period (e.g., CONSOL group recruited in 6-month period with pre-CONSOL group in the 6 months prior CONSOL. Vital sign measured respiratory rate. Abnormal vital sign cutoffs are listed below: Respiratory Rate (breaths/minute) 1-4 years old <20 or >30 5-12 years old <16 or >20 13-18 years old <12 or >16	During the intervention (vital sign monitoring using the Garmin Venu 3)
Change in SPO2 with CONSOL compared to pre-CONSOL implementation	The investigators will implement CONSOL and record the abnormal vital signs indicative of clinically meaningful events in the CONSOL group. The investigators will then compare the number of abnormal vital signs detected in the CONSOL group to that of the group of patient before CONSOL is implemented. The investigators will match the 2 groups on time period (e.g., CONSOL group recruited in 6-month period with pre-CONSOL group in the 6 months prior CONSOL. Vital sign measured SPO2. Abnormal vital sign cutoffs are listed below: SPO2<92%	During the intervention (vital sign monitoring using the Garmin Venu 3)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in time to detection of abnormal heart rate using CONSOL	Change in time to detection of abnormal heart rate (HR) will be estimated by assessing detection of abnormal HR in intervals of 15 minutes up to 6 hours (usual care intervals of manual VS measurement). Since CONSOL will be implemented in addition to usual care manual HR measurement, abnormal HR detected by CONSOL can be compared to abnormal HR detected by manual measurement at each interval. Abnormal heart rate cutoffs are listed below: Heart Rate (beats/minute) 1-4 years old < 60 or >120 5-12 years old <60 or >110 13-18 years old <60 or >100	During the intervention (vital sign monitoring using the Garmin Venu 3)
Change in time to detection of abnormal SPO2 using CONSOL	Change in time to detection of abnormal SPO2 will be estimated by assessing detection of abnormal SPO2 in intervals of 15 minutes up to 6 hours (usual care intervals of manual VS measurement). Since CONSOL will be implemented in addition to usual care manual SPO2 measurement, abnormal SPO2 detected by CONSOL can be compared to abnormal SPO2 detected by manual measurement at each interval. Abnormal SPO2, cutoffs are listed below: SpO2 (%) <92%	During the intervention (vital sign monitoring using the Garmin Venu 3)
Change in time to detection of abnormal respiratory rate using CONSOL	Change in time to detection of abnormal respiratory rate (RR) will be estimated by assessing detection of abnormal RR in intervals of 15 minutes up to 6 hours (usual care intervals of manual RR measurement). Since CONSOL will be implemented in addition to usual care manual RR measurement, abnormal RR detected by CONSOL can be compared to abnormal RR detected by manual measurement at each interval. Abnormal respiratory rate cutoffs are listed below: Respiratory Rate (breaths/minute) 1-4 years old <20 or >30 5-12 years old <16 or >20 13-18 years old <12 or >16	During the intervention (vital sign monitoring using the Garmin Venu 3)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Exploratory outcome: Investigation of the dynamic heart rate patterns associated with clinical deterioration and rescue interventions	The dynamic VS patterns associated with clinical deterioration and rescue interventions will be examined only for patients who experienced a rescue intervention. Vital signs measured is heart rate. Rescue interventions are defined as actions taken to stabilize a patient with quickly deteriorating physiological status.	During the intervention (vital sign monitoring using the Garmin Venu 3)
Exploratory outcome: Investigation of the dynamic SPO2 patterns associated with clinical deterioration and rescue interventions	The dynamic VS patterns associated with clinical deterioration and rescue interventions will be examined only for patients who experienced a rescue intervention. Vital signs measured is SPO2. Rescue interventions are defined as actions taken to stabilize a patient with quickly deteriorating physiological status.	During the intervention (vital sign monitoring using the Garmin Venu 3)
Exploratory outcome: Investigation of the dynamic skin temperature patterns associated with clinical deterioration and rescue interventions	The dynamic VS patterns associated with clinical deterioration and rescue interventions will be examined only for patients who experienced a rescue intervention. Vital signs measured is skin temperature. Rescue interventions are defined as actions taken to stabilize a patient with quickly deteriorating physiological status.	During the intervention (vital sign monitoring using the Garmin Venu 3)
Exploratory outcome: Investigation of the dynamic respiratory rate patterns associated with clinical deterioration and rescue interventions	The dynamic VS patterns associated with clinical deterioration and rescue interventions will be examined only for patients who experienced a rescue intervention. Vital signs measured is respiratory rate. Rescue interventions are defined as actions taken to stabilize a patient with quickly deteriorating physiological status.	During the intervention (vital sign monitoring using the Garmin Venu 3)

Collaborators and Investigators

• Sponsor: University of Alabama at Birmingham
• Collaborators: Northwestern University; University of Chicago; Ann & Robert H Lurie Children's Hospital of Chicago; University of Ghana; Loyola University

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): November 30, 2029
• Study Completion (Estimated): January 30, 2030

Study Registration Dates

• First Submitted: November 22, 2024
• First Submitted That Met QC Criteria: December 16, 2024
• First Posted (Actual): December 18, 2024

Study Record Updates

• Last Update Posted (Actual): May 6, 2026
• Last Update Submitted That Met QC Criteria: April 30, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: trauma; vital sign monitoring; pediatric appendectomy; Garmin Venu 3
• Additional Relevant MeSH Terms: Neoplasms; Immune System Diseases; Neoplasms by Histologic Type; Hematologic Diseases; Lymphatic Diseases; Lymphoproliferative Disorders; Immunoproliferative Disorders; Leukemia, Lymphoid; Leukemia; Hemic and Lymphatic Diseases; Wounds and Injuries; Precursor Cell Lymphoblastic Leukemia-Lymphoma
• Other Study ID Numbers: IRB-300013798

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: IPDs are considered PHI and can only be shared in a de-identified form. We have plans to share these de-identified data on ICPSR as per the Data Management and Sharing plan required by NIH

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No