Hospital Based Continuous Patient Monitoring System

NCT06739447 | Not Yet Recruiting

• 1 other identifier: IRB-300013798
• Study Type: interventional
• Target: 250
• Locations: 0 countries
• Sites: N/A

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 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.

Conditions

Trauma; Appendectomy; Pediatric ALL; Vital Signs Monitoring

Keywords

Garmin Venu 3; pediatric appendectomy; trauma; vital sign monitoring

Outcome Measures

Primary Outcomes (3)

• Change in heart rate with CONSOL compared to pre-CONSOL implementation

  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

  During the intervention (vital sign monitoring using the Garmin Venu 3)

• Change in respiratory rate with CONSOL compared to pre-CONSOL implementation

  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

  During the intervention (vital sign monitoring using the Garmin Venu 3)

• Change in SPO2 with CONSOL compared to pre-CONSOL implementation

  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%

  During the intervention (vital sign monitoring using the Garmin Venu 3)

Secondary Outcomes (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)

Other Outcomes (4)

• Exploratory outcome: Investigation of the dynamic heart rate patterns associated with clinical deterioration and rescue interventions

  During the intervention (vital sign monitoring using the Garmin Venu 3)

• Exploratory outcome: Investigation of the dynamic SPO2 patterns associated with clinical deterioration and rescue interventions

  During the intervention (vital sign monitoring using the Garmin Venu 3)

• Exploratory outcome: Investigation of the dynamic skin temperature patterns associated with clinical deterioration and rescue interventions

  During the intervention (vital sign monitoring using the Garmin Venu 3)

Study Arms (1)

Consumer Wearable Device Measurement

EXPERIMENTAL

Consumer wearable devices (CWD)

Other: Consumer Wearable Device Vital Sign Measurement

Interventions

Consumer Wearable Device Vital Sign Measurement OTHER

Consumer Wearable Devices such as the Fitbit, are durable devices that can provide vital sign data.

Consumer Wearable Device Measurement

Eligibility Criteria

• Age: 3 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Alabama at Birmingham: lead
• Northwestern University: collaborator
• University of Chicago: collaborator
• Ann & Robert H Lurie Children's Hospital of Chicago: collaborator
• University of Ghana: collaborator
• Loyola University: collaborator

MeSH Terms

Conditions

Wounds and Injuries; Precursor Cell Lymphoblastic Leukemia-Lymphoma

Condition Hierarchy (Ancestors)

Leukemia, Lymphoid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Central Study Contacts

Hassan Ghomrawi, PhD

CONTACT

205-930-7781; ghomrawi@uab.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: Patients admitted to the Pediatric Trauma Unit in the Emergency Department and Pediatric Patients who have undergone an appendectomy

Study Record Dates

• First Submitted: November 22, 2024
• First Posted: December 18, 2024
• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): November 30, 2029
• Study Completion (Estimated): January 30, 2030
• Last Updated: May 6, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share