Quantifying Activity Using Wireless Wearable Technology

Completed

• Conditions: Activity, Motor; Sleep; Delirium
• Interventions: Device: Wireless Wearable Device

• Registration Number: NCT03277118
• Lead Sponsor: University of Texas Southwestern Medical Center

Brief Summary

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

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.

Study Timeline

• Study Start: 2017-04-18
• Study First Submitted: 2017-05-17
• Study First Submitted QC: 2017-09-07
• Study First Posted: 2017-09-08
• Primary Completion: 2019-08-18
• Study Completion: 2019-08-18
• Status Verified: 2019-10
• Last Update Submitted: 2019-10-02
• Last Update Posted: 2019-10-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 91

Inclusion Criteria

• Inclusion Criteria: Adult (Age > 18) patients undergoing scheduled, elective cardiac surgery with cardiopulmonary bypass

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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.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Cardiac Surgery Cohort	Wireless Wearable Device	Patients aged 18 years or older who are scheduled to undergo elective cardiac surgery with cardiopulmonary bypass.

Primary Outcome Measures

Name	Time	Method
Number of steps walked	Postoperative day 2 to Postoperative day 5	Number of steps walked as measured by the Wireless Wearable Device

Secondary Outcome Measures

Name	Time	Method
Length of sleep	Postoperative Day 1	Number of hours slept with little activity as measured by the Wireless Wearable Device
Delirium	Postoperative Day 2 (after extubation)	Occurrence of delirium with few hours slept as measured by the Wireless Wearable Device

Trial Locations

Locations (1)

UT Southwestern Medical Center; 🇺🇸 Dallas, Texas, United States