NCT04824066

The Role of Wearable Devices in Cardiothoracic Surgery: Predicting and Detecting Early Postoperative Complications

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 1,200 (estimated)
• Sponsor: Massachusetts General Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The overarching goal of this research is to use machine learning analysis of high-resolution data-collected by wearable technology-of cardiothoracic surgical patients to assess recovery and detect complications at their earliest stage

Detailed description

This is a single-center non-randomized prospective cohort study using wearable devices in cardiothoracic surgery patients to detect post-operative complications. Patients undergoing cardiothoracic surgery who meet the inclusion and exclusion criteria will be enrolled consecutively with verbal informed consent from the time this protocol is approved by the IRB until 1,200 subjects are enrolled. At \~30 days preoperatively the subjects will have a wearable device (such as a Fitbit) placed on their wrist and will wear the device until \~180 days post-operatively. This device will wirelessly transmit data regarding activity and sleep quality to a smartphone application for the duration of wear and data will be analyzed by our collaborators at Case Western Reserve University.

Conditions

• Surgery--Complications

Interventions

Type	Name	Description
DEVICE	Device: Wearable Device	A Wearable Device will be placed on the wrist of the patient \~30 days prior to the patient's scheduled surgery, removed during the operation, and replaced for \~180 days post-operatively. The device will record activity in terms of steps, sleep quality, heart rate, etc.

Timeline

• Start date: 2021-07-10
• Primary completion: 2029-01-01
• Completion: 2029-06-30
• First posted: 2021-04-01
• Last updated: 2026-02-20

Locations

1 site across 1 country: United States