Quantifying Activity Using Wireless Wearable Technology

Sleep Clinical Trial

Official title:

Quantifying Activity After Cardiac Surgery Using Wireless Wearable Technology

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03277118
• Other study ID #: STU 032017-102
• Status: Completed
• Start date: April 18, 2017
• Est. completion date: August 18, 2019

Study information

• Verified date: October 2019
• Source: University of Texas Southwestern Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 91
• Est. completion date: August 18, 2019
• Est. primary completion date: August 18, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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.

Related Conditions & MeSH terms

• Activity, Motor
• Delirium
• Sleep

Intervention

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.

Locations

Country	Name	City	State
United States	UT Southwestern Medical Center	Dallas	Texas

Sponsors (1)

Lead Sponsor	Collaborator
University of Texas Southwestern Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of steps walked	Number of steps walked as measured by the Wireless Wearable Device	Postoperative day 2 to Postoperative day 5
Secondary	Length of sleep	Number of hours slept with little activity as measured by the Wireless Wearable Device	Postoperative Day 1
Secondary	Delirium	Occurrence of delirium with few hours slept as measured by the Wireless Wearable Device	Postoperative Day 2 (after extubation)