Quantifying Activity Using Wireless Wearable Technology

Study Overview
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Brief Summary
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Wireless wearable devices (WWD) have been shown to be an effective means to measure patient activity and sleep-wake cycles in the ICU. However, no current studies involving WWD have demonstrated the ability of these devices to measure adverse outcomes, including delirium in critically ill patients. This study is unique because the investigators will implement monitoring with the WWD prior to extubation in the ICU to correctly measure first mobilization, as well as capture quality of sleep and episodes of delirium for the first five postoperative days.

Detailed Description
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In this single-center non-randomized prospective cohort study, cardiac surgical patients undergoing cardiac surgery with cardiopulmonary bypass will be enrolled consecutively with written informed consent from the time this protocol is approved by the IRB until 100 subjects are enrolled (expected duration of subject enrollment is 12 months). Upon arrival into the ICU, cardiac surgery subjects will have a Fitbit Charge 2 device placed on their wrist and will wear the device until the fifth post-operative day. This device will wirelessly transmit data regarding activity and sleep quality to a smartphone application for the duration of wear. No identifiable patient information will be entered into the smartphone application or transmitted to any external entity.

Official Title
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Quantifying Activity After Cardiac Surgery Using Wireless Wearable Technology

Conditions
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Activity, Motor, Sleep, Delirium

Intervention / Treatment
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* Device: Wireless Wearable Device


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Inclusion Criteria: Adult (Age > 18) patients undergoing scheduled, elective cardiac surgery with cardiopulmonary bypass Exclusion Criteria: Those who do not meet the inclusion criteria, pregnant women, prisoners, those with skin or systemic infections, those who are paraplegic or quadriplegic and those with allergies to the polyurethane material comprising the FitBit strap.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Cardiac Surgery Cohort<br>Patients aged 18 years or older who are scheduled to undergo elective cardiac surgery with cardiopulmonary bypass. | Device: Wireless Wearable Device<br>* Wireless Wearable Device will be placed on the wrist of the patient prior to extubation in the ICU to record patient activity in terms of steps and sleep quality.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of steps walked | Number of steps walked as measured by the Wireless Wearable Device | Postoperative day 2 to Postoperative day 5 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Length of sleep | Number of hours slept with little activity as measured by the Wireless Wearable Device | Postoperative Day 1 | 
| Delirium | Occurrence of delirium with few hours slept as measured by the Wireless Wearable Device | Postoperative Day 2 (after extubation) |