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

Mass General Brigham

Status: Enrolling

Conditions: Surgery--Complications

Treatments: Device: Device: Wearable Device

Study type: Observational

Funder types: Other

Identifiers

NCT04824066

2020P002984

Details and patient eligibility

About

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

Full 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.

Enrollment: 1,200 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

1,200 participants in 1 patient group

Cardiothoracic Surgery Cohort

Description:

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

Treatment:

Device: Device: Wearable Device