Quantifying Activity Using Wireless Wearable Technology

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

91 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-04-18

Study Completion Date

2019-08-18

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.

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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.

Conditions

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Activity, Motor Sleep Delirium

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Cardiac Surgery Cohort

Patients aged 18 years or older who are scheduled to undergo elective cardiac surgery with cardiopulmonary bypass.

Wireless Wearable Device

Intervention Type DEVICE

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.

Interventions

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Wireless Wearable Device

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.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No