Implementing a Hospital-based Continuous Patient Monitoring System Using Consumer Wearable Devices in Ghana
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 250
- 主要终点
- Change in heart rate with CONSOL compared to pre-CONSOL implementation
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 3 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Pediatric patients presenting with traumatic injury
- •Pediatric patients postoperative status after an appendectomy
排除标准
- •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
研究组 & 干预措施
Consumer Wearable Device Measurement
Consumer wearable devices (CWD)
干预措施: Consumer Wearable Device Vital Sign Measurement (Other)
结局指标
主要结局
Change in heart rate with CONSOL compared to pre-CONSOL implementation
时间窗: 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
Change in respiratory rate with CONSOL compared to pre-CONSOL implementation
时间窗: 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
Change in SPO2 with CONSOL compared to pre-CONSOL implementation
时间窗: 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%
Change in heart rate with CONSOL compared to pre-CONSOL implementation
时间窗: 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
Change in respiratory rate with CONSOL compared to pre-CONSOL implementation
时间窗: 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
Change in SPO2 with CONSOL compared to pre-CONSOL implementation
时间窗: 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%
次要结局
- Change in time to detection of abnormal heart rate using CONSOL(During the intervention (vital sign monitoring using the Garmin Venu 3))
- Change in time to detection of abnormal SPO2 using CONSOL(During the intervention (vital sign monitoring using the Garmin Venu 3))
- Change in time to detection of abnormal respiratory rate using CONSOL(During the intervention (vital sign monitoring using the Garmin Venu 3))
- Change in time to detection of abnormal heart rate using CONSOL(During the intervention (vital sign monitoring using the Garmin Venu 3))
- Change in time to detection of abnormal SPO2 using CONSOL(During the intervention (vital sign monitoring using the Garmin Venu 3))
- Change in time to detection of abnormal respiratory rate using CONSOL(During the intervention (vital sign monitoring using the Garmin Venu 3))
研究者
Hassan Ghomrawi
Associate Professor
University of Alabama at Birmingham