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

Surgery--Complications Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04824066
• Other study ID #: 2020P002984
• Status: Recruiting
• Start date: July 10, 2021
• Est. completion date: June 30, 2027

Study information

• Verified date: June 2023
• Source: Massachusetts General Hospital
• Contact: Chi-Fu Jeffrey Yang, MD
• Phone: 617-726-5200
• Email: cjyang[@]mgh.harvard.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1200
• Est. completion date: June 30, 2027
• Est. primary completion date: January 1, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Postoperative Complications
• Surgery--Complications

Intervention

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.

Locations

Country	Name	City	State
United States	Massachusetts General Hospital	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Massachusetts General Hospital	Case Western Reserve University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Early detection of postoperative complications using machine learning analysis of patient biometric data.	Proportion of complications detected by the machine learning algorithm.	Four Years
Primary	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