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

NCT04824066 | Recruiting

• 1 other identifier: 2020P002984
• Study Type: observational
• Target: 1,200
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Surgery--Complications

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (1)

Cardiothoracic Surgery Cohort

Adults patients who are scheduled to undergo cardiothoracic surgery and meet the inclusion and exclusion criteria.

Device: Device: Wearable Device

Interventions

Device: Wearable Device 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.

Cardiothoracic Surgery Cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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).
• Individuals willing to provide informed consent and who have capacity for all study procedures

You may not qualify if:

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

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• Case Western Reserve University: collaborator

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

RECRUITING

MeSH Terms

Interventions

Wearable Electronic Devices

Intervention Hierarchy (Ancestors)

Electrical Equipment and Supplies; Equipment and Supplies

Study Officials

• Chi-Fu Jeffrey Yang

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Chi-Fu Jeffrey Yang, MD

CONTACT

617-726-5200; cjyang@mgh.harvard.edu

Isha Mehta Warikoo, MD

CONTACT

857-250-1355; imehtawarikoo@mgh.harvard.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: March 11, 2021
• First Posted: April 1, 2021
• Study Start: July 10, 2021
• Primary Completion (Estimated): January 1, 2029
• Study Completion (Estimated): June 30, 2029
• Last Updated: February 20, 2026

Record last verified: 2026-02

Locations

US (1)