Quantifying Activity Using Wireless Wearable Technology

• ClinicalTrials.gov Identifier: NCT03277118
• Recruitment Status: Completed
• First Posted: September 8, 2017
• Last Update Posted: October 3, 2019
• Sponsor: University of Texas Southwestern Medical Center
• Information provided by (Responsible Party): Sreekanth Cheruku, University of Texas Southwestern Medical Center

Study Description

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.

Study Design

• 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

Groups and Cohorts

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.

Outcome Measures

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

Eligibility Criteria

• 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.

Contacts and Locations

Locations

United States, Texas

UT Southwestern Medical Center

Dallas, Texas, United States, 75390

Sponsors and Collaborators

University of Texas Southwestern Medical Center

Investigators

• Principal Investigator: Sreekanth Cheruku, MD; UT Southwestern Medical Center

More Information

• 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
• 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

Additional relevant MeSH terms:

Delirium; Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Neurocognitive Disorders; Mental Disorders