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Clinical Trials/NCT03277118
NCT03277118
Completed
Not Applicable

Quantifying Activity After Cardiac Surgery Using Wireless Wearable Technology

University of Texas Southwestern Medical Center1 site in 1 country91 target enrollmentApril 18, 2017

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Activity, Motor
Sponsor
University of Texas Southwestern Medical Center
Enrollment
91
Locations
1
Primary Endpoint
Number of steps walked
Status
Completed
Last Updated
6 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
April 18, 2017
End Date
August 18, 2019
Last Updated
6 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Sreekanth Cheruku

Assistant Professor

University of Texas Southwestern Medical Center

Eligibility 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.

Outcomes

Primary Outcomes

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 Outcomes

  • Length of sleep(Postoperative Day 1)
  • Delirium(Postoperative Day 2 (after extubation))

Study Sites (1)

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