Hospital Based Continuous Patient Monitoring System

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

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

Первичные конечные точки

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

Вторичные конечные точки (3)

• Change in time to detection of abnormal heart rate using CONSOL [Срок оценки: During the intervention (vital sign monitoring using the Garmin Venu 3)]
• Change in time to detection of abnormal SPO2 using CONSOL [Срок оценки: During the intervention (vital sign monitoring using the Garmin Venu 3)]
• Change in time to detection of abnormal respiratory rate using CONSOL [Срок оценки: During the intervention (vital sign monitoring using the Garmin Venu 3)]

Критерии участия

Критерии включения

• Pediatric patients presenting with traumatic injury
• Pediatric patients postoperative status after an appendectomy

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Нерандомизированное

Модель

Последовательный дизайн

Маскирование

Открытое

Основная цель

Диагностика

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT06739447 · IRB-300013798 · R21TW012943

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗