TraumaNCT06739447
Hospital Based Continuous Patient Monitoring System
A study testing Consumer Wearable Device Vital Sign Measurement in people with Trauma and Appendectomy, run by University of Alabama at Birmingham.
Trial 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. Read more about this study
- Who is it for?
- Ages 3 to 18 years
- Conditions the study is for
- Trauma, Appendectomy, Pediatric ALL
- What is being tested?
- Consumer Wearable Device Vital Sign Measurement
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 250 participants
- Where
- No sites listed yet
- Study dates
- 1 Nov 2026to 30 Jan 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Pediatric patients presenting with traumatic injury
- Pediatric patients postoperative status after an appendectomy
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Implementing a Hospital-based Continuous Patient Monitoring System Using Consumer Wearable Devices in Ghana
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.
Read the 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.
- Conditions
- Trauma, Appendectomy, Pediatric ALL, Vital Signs Monitoring
- Being tested
- Consumer Wearable Device Vital Sign Measurement
- Keywords
- Garmin Venu 3, pediatric appendectomy, trauma, vital sign monitoring
- Medical subject headings
- Wounds and Injuries, Precursor Cell Lymphoblastic Leukemia-Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Consumer Wearable Device Vital Sign MeasurementOther
Consumer Wearable Devices such as the Fitbit, are durable devices that can provide vital sign data.
| Study group | Role | What they receive |
|---|---|---|
| Consumer Wearable Device Measurement | Experimental | Consumer wearable devices (CWD) Receives: Other: Consumer Wearable Device Vital Sign Measurement |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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%
Measured: 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
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
Measured: During the intervention (vital sign monitoring using the Garmin Venu 3)
Change in time to detection of abnormal SPO2 using CONSOL
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%
Measured: During the intervention (vital sign monitoring using the Garmin Venu 3)
Change in time to detection of abnormal respiratory rate using CONSOL
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
Measured: During the intervention (vital sign monitoring using the Garmin Venu 3)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2024
- Study start1 Nov 2026 (estimated)
- Primary completion30 Nov 2029 (estimated)
- Study completion30 Jan 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TraumaStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Model description
- Patients admitted to the Pediatric Trauma Unit in the Emergency Department and Pediatric Patients who have undergone an appendectomy
- Masking
- None (open label)
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Collaborators
- Northwestern University, University of Chicago, Ann & Robert H Lurie Children's Hospital of Chicago, University of Ghana, Loyola University, Fogarty International Center of the National Institute of Health, National Institutes of Health (NIH)
- Responsible party
- Principal investigator, Hassan Ghomrawi, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06739447
- Sponsor's protocol ID
- IRB-300013798
- Other IDs
- R21TW012943
- Status last verified
- Sep 2026
- First submitted
- 22 Nov 2024
- Last updated
- 8 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPDs are considered PHI and can only be shared in a de-identified form. We have plans to share these de-identified data on ICPSR as per the Data Management and Sharing plan required by NIH
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implementing a Hospital-based Continuous Patient Monitoring System Using Consumer Wearable Devices in Ghana
- ClinicalTrials.gov ID
- NCT06739447
- Acronym / sponsor ID
- IRB-300013798
- Conditions
- Trauma, Appendectomy, Pediatric ALL, Vital Signs Monitoring
- Keywords
- Garmin Venu 3, pediatric appendectomy, trauma, vital sign monitoring
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Collaborators
- Northwestern University, University of Chicago, Ann & Robert H Lurie Children's Hospital of Chicago, University of Ghana, Loyola University, Fogarty International Center of the National Institute of Health, National Institutes of Health (NIH)
- Study start
- 1 Nov 2026 (estimated)
- Primary completion
- 30 Nov 2029 (estimated)
- Study completion
- 30 Jan 2030 (estimated)
- First posted
- 18 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Patients admitted to the Pediatric Trauma Unit in the Emergency Department and Pediatric Patients who have undergone an appendectomy
| Arm | Type | Receives |
|---|---|---|
| Consumer Wearable Device Measurement | Experimental | Other: Consumer Wearable Device Vital Sign MeasurementConsumer wearable devices (CWD) |
Who may qualify
- Ages
- 3 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- Pediatric patients presenting with traumatic injury
- Pediatric patients postoperative status after an appendectomy
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Consumer Wearable Device Vital Sign MeasurementConsumer Wearable Devices such as the Fitbit, are durable devices that can provide vital sign data. | Other | Consumer Wearable Device Measurement |
Primary outcome
Change in heart rate with CONSOL compared to pre-CONSOL implementation
Time frame: 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
Time frame: 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
Time frame: 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%
3 secondary outcomes
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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2026.
- Individual participant dataSharing planned: No. IPDs are considered PHI and can only be shared in a de-identified form. We have plans to share these de-identified data on ICPSR as per the Data Management and Sharing plan required by NIH
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing Consumer Wearable Device Vital Sign Measurement in people with Trauma and Appendectomy, run by University of Alabama at Birmingham.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 8 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hassan Ghomrawi, PhD (205-930-7781, ghomrawi@uab.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in heart rate with CONSOL compared to pre-CONSOL implementation (time frame: During the intervention (vital sign monitoring using the Garmin Venu 3)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Oct 2026.