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Not yet recruiting NCT06739447

Hospital Based Continuous Patient Monitoring System

No phase Interventional Trauma Appendectomy Pediatric ALL Vital Signs Monitoring

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Consumer Wearable Device Vital Sign Measurement.
Who it may be relevant to
Registry conditions: Trauma, Appendectomy, Pediatric ALL, Vital Signs Monitoring. Basic parameters: 3 years — 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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.

Interventions

  • Other Consumer Wearable Device Vital Sign Measurement
    Consumer Wearable Devices such as the Fitbit, are durable devices that can provide vital sign data.

Primary outcome measures

  • Change in heart rate with CONSOL compared to pre-CONSOL implementation [Time frame: During the intervention (vital sign monitoring using the Garmin Venu 3)]
  • Change in respiratory rate with CONSOL compared to pre-CONSOL implementation [Time frame: During the intervention (vital sign monitoring using the Garmin Venu 3)]
  • Change in SPO2 with CONSOL compared to pre-CONSOL implementation [Time frame: During the intervention (vital sign monitoring using the Garmin Venu 3)]
Secondary outcome measures (3)
  • 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 SPO2 using CONSOL [Time frame: During the intervention (vital sign monitoring using the Garmin Venu 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)]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Non-randomized
Model
Sequential
Masking
Open label
Primary purpose
Diagnostic

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT06739447 · IRB-300013798 · R21TW012943

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗