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

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

Study Overview

• Status: Recruiting
• Conditions: Surgery--Complications
• Intervention / Treatment: Device: Device: Wearable Device

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.

• Study Type: Observational
• Enrollment (Estimated): 1200

Contacts and Locations

• Study Contact: Name: Chi-Fu Jeffrey Yang, MD; Phone Number: 617-726-5200; Email: cjyang@mgh.harvard.edu
• Study Contact Backup: Name: Isha Mehta Warikoo, MD; Phone Number: 857-250-1355; Email: imehtawarikoo@mgh.harvard.edu

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Recruiting
      • Massachusetts General Hospital
      • Contact: Chi-Fu J Yang, M.D.; Phone Number: 814-574-8695; Email: cjyang@mgh.harvard.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients undergoing cardiothoracic surgery that are amenable to wearing a device of interest and meet the inclusion and exclusion criteria above will be approached for informed consent.

Description

Inclusion Criteria:

1. Age 18 years or older undergoing cardiothoracic surgery that is male or a non-pregnant female and are amenable to using one of the wearable devices of interest (Fitbit, iWatch, Biostrap).
2. Individuals willing to provide informed consent and who have capacity for all study procedures

Exclusion Criteria:

1. Individuals with mental incapacity and/or cognitive impairment that would preclude adequate understanding of, or cooperation with the study protocol.
2. Any pregnant participant.
3. Severe irreversible pulmonary hypertension.
4. Congenital heart disease
5. Chronic renal insufficiency or undergoing chronic renal replacement therapy
6. Liver cirrhosis

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Cardiothoracic Surgery Cohort; Adults patients who are scheduled to undergo cardiothoracic surgery and meet the inclusion and exclusion criteria.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Early detection of postoperative complications using machine learning analysis of patient biometric data.	Proportion of complications detected by the machine learning algorithm.	Four Years
Prediction of the quality of postoperative recovery using pre- and intraoperative data.	Proportion of patients whose quality of postoperative recovery is correctly predicted by the machine learning algorithm.	Four Years

Collaborators and Investigators

• Sponsor: Massachusetts General Hospital
• Collaborators: Case Western Reserve University
• Investigators: Principal Investigator: Chi-Fu Jeffrey Yang, Massachusetts General Hospital

Study record dates

Study Major Dates

• Study Start (Actual): July 10, 2021
• Primary Completion (Estimated): January 1, 2026
• Study Completion (Estimated): June 30, 2027

Study Registration Dates

• First Submitted: March 11, 2021
• First Submitted That Met QC Criteria: March 26, 2021
• First Posted (Actual): April 1, 2021

Study Record Updates

• Last Update Posted (Estimated): June 13, 2023
• Last Update Submitted That Met QC Criteria: June 9, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications
• Other Study ID Numbers: 2020P002984

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No