Hospital Based Continuous Patient Monitoring System

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age3-18
SponsorUniversity of Alabama at Birmingham

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Pediatric patients presenting with traumatic injury

Pediatric patients postoperative status after an appendectomy

Disqualifiers

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 design

Design model

Sequential

Treatments tested in this trial

  • Consumer Wearable Device Vital Sign Measurement

    Other intervention

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

Treatment groups

250 Participants
are divided into 1 treatment group
Group A: Consumer Wearable Device MeasurementExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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

Time frame
During the intervention (vital sign monitoring using the Garmin Venu 3)
2

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

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

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

Secondary outcomes

1

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

Time frame
During the intervention (vital sign monitoring using the Garmin Venu 3)
2

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%

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

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

Other outcomes

1

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

The dynamic VS patterns associated with clinical deterioration and rescue interventions will be examined only for patients who experienced a rescue intervention. Vital signs measured is heart rate. Rescue interventions are defined as actions taken to stabilize a patient with quickly deteriorating physiological status.

Time frame
During the intervention (vital sign monitoring using the Garmin Venu 3)
2

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

The dynamic VS patterns associated with clinical deterioration and rescue interventions will be examined only for patients who experienced a rescue intervention. Vital signs measured is SPO2. Rescue interventions are defined as actions taken to stabilize a patient with quickly deteriorating physiological status.

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

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

The dynamic VS patterns associated with clinical deterioration and rescue interventions will be examined only for patients who experienced a rescue intervention. Vital signs measured is skin temperature. Rescue interventions are defined as actions taken to stabilize a patient with quickly deteriorating physiological status.

Time frame
During the intervention (vital sign monitoring using the Garmin Venu 3)
4

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

The dynamic VS patterns associated with clinical deterioration and rescue interventions will be examined only for patients who experienced a rescue intervention. Vital signs measured is respiratory rate. Rescue interventions are defined as actions taken to stabilize a patient with quickly deteriorating physiological status.

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

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Alabama at Birmingham

Lead sponsor

Northwestern University

Collaborator

University of Chicago

Collaborator

Ann & Robert H Lurie Children's Hospital of Chicago

Collaborator

University of Ghana

Collaborator

Loyola University

Collaborator

Fogarty International Center of the National Institute of Health

Collaborator

National Institutes of Health (NIH)

Collaborator

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