Quantifying Activity Using Wireless Wearable Technology
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ClinicalTrials.gov Identifier: NCT03277118 |
Recruitment Status :
Completed
First Posted : September 8, 2017
Last Update Posted : October 3, 2019
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Condition or disease | Intervention/treatment |
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Activity, Motor Sleep Delirium | Device: Wireless Wearable Device |
Study Type : | Observational |
Actual Enrollment : | 91 participants |
Observational Model: | Cohort |
Time Perspective: | Prospective |
Official Title: | Quantifying Activity After Cardiac Surgery Using Wireless Wearable Technology |
Actual Study Start Date : | April 18, 2017 |
Actual Primary Completion Date : | August 18, 2019 |
Actual Study Completion Date : | August 18, 2019 |
Group/Cohort | Intervention/treatment |
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Cardiac Surgery Cohort
Patients aged 18 years or older who are scheduled to undergo elective cardiac surgery with cardiopulmonary bypass.
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Device: 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. |
- Number of steps walked [ Time Frame: Postoperative day 2 to Postoperative day 5 ]Number of steps walked as measured by the Wireless Wearable Device
- Length of sleep [ Time Frame: Postoperative Day 1 ]Number of hours slept with little activity as measured by the Wireless Wearable Device
- Delirium [ Time Frame: Postoperative Day 2 (after extubation) ]Occurrence of delirium with few hours slept as measured by the Wireless Wearable Device

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Ages Eligible for Study: | 18 Years to 100 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03277118
United States, Texas | |
UT Southwestern Medical Center | |
Dallas, Texas, United States, 75390 |
Principal Investigator: | Sreekanth Cheruku, MD | UT Southwestern Medical Center |
Responsible Party: | Sreekanth Cheruku, Assistant Professor, University of Texas Southwestern Medical Center |
ClinicalTrials.gov Identifier: | NCT03277118 |
Other Study ID Numbers: |
STU 032017-102 |
First Posted: | September 8, 2017 Key Record Dates |
Last Update Posted: | October 3, 2019 |
Last Verified: | October 2019 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Delirium Confusion Neurobehavioral Manifestations Neurologic Manifestations |
Nervous System Diseases Neurocognitive Disorders Mental Disorders |