Quantifying Activity Using Wireless Wearable Technology
| Status: | Recruiting |
|---|---|
| Conditions: | Insomnia Sleep Studies, Neurology, Psychiatric |
| Therapuetic Areas: | Neurology, Psychiatry / Psychology |
| Healthy: | No |
| Age Range: | 18 - 100 |
| Updated: | 10/13/2018 |
| Start Date: | April 18, 2017 |
| End Date: | April 18, 2019 |
Quantifying Activity After Cardiac Surgery Using Wireless Wearable Technology
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.
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.
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.
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.
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.
We found this trial at
1
site
2201 Inwood Rd
Dallas, Texas 75235
Dallas, Texas 75235
(214) 645-8300
Phone: 214-648-6400
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