Hospital Based Continuous Patient Monitoring System

Not Applicable

Not yet recruiting

• Conditions: Trauma; Appendectomy; Pediatric ALL; Vital Signs Monitoring

• Registration Number: NCT06739447
• Lead Sponsor: University of Alabama at Birmingham

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.

Study Timeline

• Study First Submitted: 2024-11-22
• Study First Submitted QC: 2024-12-16
• Study First Posted: 2024-12-18
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-15
• Last Update Posted: 2025-05-21
• Study Start: 2025-07
• Primary Completion: 2030-12
• Study Completion: 2031-02

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 250

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Primary Outcome Measures

Name	Time	Method
Change in heart rate with CONSOL compared to pre-CONSOL implementation	During the intervention (vital sign monitoring using the Fitbit)	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	During the intervention (vital sign monitoring using the Fitbit)	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 skin temperature with CONSOL compared to pre-CONSOL implementation	During the intervention (vital sign monitoring using the Fitbit)	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 signs measured is skin temperature. Abnormal vital sign cutoffs are listed below: Temperature (degrees) \<95 or \>100.3
Change in SPO2 with CONSOL compared to pre-CONSOL implementation	During the intervention (vital sign monitoring using the Fitbit)	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 Outcome Measures

Name	Time	Method
Change in time to detection of abnormal heart rate using CONSOL	During the intervention (vital sign monitoring using the Fitbit)	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
Change in time to detection of abnormal SPO2 using CONSOL	During the intervention (vital sign monitoring using the Fitbit)	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%
Change in time to detection of abnormal skin temperature (T) using CONSOL	During the intervention (vital sign monitoring using the Fitbit)	Change in time to detection of abnormal skin temperature (T) will be estimated by assessing detection of abnormal T in intervals of 15 minutes up to 6 hours (usual care intervals of manual T measurement). Since CONSOL will be implemented in addition to usual care manual T measurement, abnormal T detected by CONSOL can be compared to abnormal T detected by manual measurement at each interval.; Abnormal T cutoffs are listed below: Temperature (degrees) \<95 or \>100.3
Change in time to detection of abnormal respiratory rate using CONSOL	During the intervention (vital sign monitoring using the Fitbit)	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