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NCT Number: NCT06739447

Hospital Based Continuous Patient Monitoring System

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.

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Key information

Conditions

Trauma Appendectomy Hematologic Diseases Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Leukemia Leukemia, Lymphoid Lymphatic Diseases Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type Pediatric ALL Precursor Cell Lymphoblastic Leukemia-Lymphoma Vital Signs Monitoring Wounds and Injuries

Age range

3 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Consumer Wearable Device Vital Sign Measurement

Other

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

Primary outcomes

  1. Change in heart rate with CONSOL compared to pre-CONSOL implementation

    Time frame: During the intervention (vital sign monitoring using the Garmin Venu 3)

    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

  2. Change in respiratory rate with CONSOL compared to pre-CONSOL implementation

    Time frame: During the intervention (vital sign monitoring using the Garmin Venu 3)

    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

  3. Change in SPO2 with CONSOL compared to pre-CONSOL implementation

    Time frame: During the intervention (vital sign monitoring using the Garmin Venu 3)

    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%

Secondary outcomes

  1. Change in time to detection of abnormal heart rate using CONSOL

    Time frame: During the intervention (vital sign monitoring using the Garmin Venu 3)

    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

  2. Change in time to detection of abnormal SPO2 using CONSOL

    Time frame: During the intervention (vital sign monitoring using the Garmin Venu 3)

    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%

  3. Change in time to detection of abnormal respiratory rate using CONSOL

    Time frame: During the intervention (vital sign monitoring using the Garmin Venu 3)

    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

Other outcomes

  1. Exploratory outcome: Investigation of the dynamic heart rate patterns associated with clinical deterioration and rescue interventions

    Time frame: During the intervention (vital sign monitoring using the Garmin Venu 3)

    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.

  2. Exploratory outcome: Investigation of the dynamic SPO2 patterns associated with clinical deterioration and rescue interventions

    Time frame: During the intervention (vital sign monitoring using the Garmin Venu 3)

    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.

  3. Exploratory outcome: Investigation of the dynamic skin temperature patterns associated with clinical deterioration and rescue interventions

    Time frame: During the intervention (vital sign monitoring using the Garmin Venu 3)

    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.

  4. Exploratory outcome: Investigation of the dynamic respiratory rate patterns associated with clinical deterioration and rescue interventions

    Time frame: During the intervention (vital sign monitoring using the Garmin Venu 3)

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Hassan Ghomrawi, PhD

CONTACT

[email protected]

205-930-7781

Sponsors and collaborators

Lead sponsor

University of Alabama at Birmingham

Other

Collaborators

  • Ann & Robert H Lurie Children's Hospital of Chicago
  • Fogarty International Center of the National Institute of Health
  • Loyola University
  • National Institutes of Health (NIH)
  • Northwestern University
  • University of Chicago
  • University of Ghana

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2029
Study completion
2030
First posted
Dec 18, 2024
Registry last updated
Jul 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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