Clinical trial NCT06739447: Hospital Based Continuous Patient Monitoring System
Official title: Implementing a Hospital-based Continuous Patient Monitoring System Using Consumer Wearable Devices in Ghana
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Trauma
Appendectomy
Pediatric ALL
Vital Signs Monitoring
Keywords: Fitbit
pediatric appendectomy
trauma
vital sign monitoring
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
Collaborators: name: Northwestern University
name: University of Chicago
name: Ann & Robert H Lurie Children's Hospital of Chicago
name: University of Ghana
First posted: 2024-12-18
Enrollment: 250
Sex: ALL
Minimum age (years): 3
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: Patients admitted to the Pediatric Trauma Unit in the Emergency Department and Pediatric Patients who have undergone an appendectomy
Primary purpose: DIAGNOSTIC

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 Fitbit, 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, skin temperature, RR, and SpO2, with snapshots of the past 1 minute, and 1, 4, and 24 hours, viewable on an iPad 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.

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

Primary outcomes:
measure: Change in heart rate with CONSOL compared to pre-CONSOL implementation
timeFrame: During the intervention (vital sign monitoring using the Fitbit)
measure: Change in respiratory rate with CONSOL compared to pre-CONSOL implementation
timeFrame: During the intervention (vital sign monitoring using the Fitbit)
measure: Change in skin temperature with CONSOL compared to pre-CONSOL implementation
timeFrame: During the intervention (vital sign monitoring using the Fitbit)
measure: Change in SPO2 with CONSOL compared to pre-CONSOL implementation
timeFrame: During the intervention (vital sign monitoring using the Fitbit)
Secondary outcomes:
measure: Change in time to detection of abnormal heart rate using CONSOL
timeFrame: During the intervention (vital sign monitoring using the Fitbit)
measure: Change in time to detection of abnormal SPO2 using CONSOL
timeFrame: During the intervention (vital sign monitoring using the Fitbit)
measure: Change in time to detection of abnormal respiratory rate using CONSOL
timeFrame: During the intervention (vital sign monitoring using the Fitbit)
measure: Change in time to detection of abnormal skin temperature (T) using CONSOL
timeFrame: During the intervention (vital sign monitoring using the Fitbit)
Other outcomes:
measure: Exploratory outcome: Investigation of the dynamic heart rate patterns associated with clinical deterioration and rescue interventions
timeFrame: During the intervention (vital sign monitoring using the Fitbit)
measure: Exploratory outcome: Investigation of the dynamic SPO2 patterns associated with clinical deterioration and rescue interventions
timeFrame: During the intervention (vital sign monitoring using the Fitbit)
measure: Exploratory outcome: Investigation of the dynamic skin temperature patterns associated with clinical deterioration and rescue interventions
timeFrame: During the intervention (vital sign monitoring using the Fitbit)
measure: Exploratory outcome: Investigation of the dynamic respiratory rate patterns associated with clinical deterioration and rescue interventions
timeFrame: During the intervention (vital sign monitoring using the Fitbit)
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