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Quantifying Activity Using Wireless Wearable Technology

Quantifying Activity After Cardiac Surgery Using Wireless Wearable Technology

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03277118
Enrollment
91
Registered
2017-09-08
Start date
2017-04-18
Completion date
2019-08-18
Last updated
2019-10-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Activity, Motor, Delirium, Sleep

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.

Interventions

DEVICEWireless 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.

Sponsors

University of Texas Southwestern Medical Center
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Number of steps walkedPostoperative day 2 to Postoperative day 5Number of steps walked as measured by the Wireless Wearable Device

Secondary

MeasureTime frameDescription
Length of sleepPostoperative Day 1Number of hours slept with little activity as measured by the Wireless Wearable Device
DeliriumPostoperative Day 2 (after extubation)Occurrence of delirium with few hours slept as measured by the Wireless Wearable Device

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026