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Quantifying Activity Using Wireless Wearable Technology

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03277118
Recruitment Status : Completed
First Posted : September 8, 2017
Last Update Posted : October 3, 2019
Sponsor:
Information provided by (Responsible Party):
Sreekanth Cheruku, 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.

Condition or disease Intervention/treatment
Activity, Motor Sleep Delirium Device: Wireless Wearable Device

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.

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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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Delirium

Group/Cohort Intervention/treatment
Cardiac Surgery Cohort
Patients aged 18 years or older who are scheduled to undergo elective cardiac surgery with cardiopulmonary bypass.
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.




Primary Outcome Measures :
  1. Number of steps walked [ Time Frame: Postoperative day 2 to Postoperative day 5 ]
    Number of steps walked as measured by the Wireless Wearable Device


Secondary Outcome Measures :
  1. Length of sleep [ Time Frame: Postoperative Day 1 ]
    Number of hours slept with little activity as measured by the Wireless Wearable Device

  2. Delirium [ Time Frame: Postoperative Day 2 (after extubation) ]
    Occurrence of delirium with few hours slept as measured by the Wireless Wearable Device



Information from the National Library of Medicine

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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
Study Population
Patients aged 18 years or older who are scheduled to undergo elective cardiac surgery at UT Southwestern Medical Center.
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.

Information from the National Library of Medicine

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


Locations
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United States, Texas
UT Southwestern Medical Center
Dallas, Texas, United States, 75390
Sponsors and Collaborators
University of Texas Southwestern Medical Center
Investigators
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Principal Investigator: Sreekanth Cheruku, MD UT Southwestern Medical Center

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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

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Delirium
Confusion
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Neurocognitive Disorders
Mental Disorders