RecruitingNCT04824066

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

Sponsor

Massachusetts General Hospital

Enrollment

1,200 participants

Start Date

Jul 10, 2021

Study Type

OBSERVATIONAL

Conditions

Surgery--Complications

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

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This prospective observational study is using wearable fitness devices — such as a Fitbit or Apple Watch — to continuously collect activity and sleep data from patients undergoing heart or lung (cardiothoracic) surgery, with the goal of using machine learning to detect early signs of post-operative complications before they become serious. Complications after cardiothoracic surgery are common and early detection is critical, and wearable devices offer a way to monitor patients continuously at home rather than only during clinic visits. Adults aged 18 or older who are scheduled for cardiothoracic surgery and are willing to wear the device and provide consent are eligible, while those with mental incapacity, pregnancy, severe pulmonary hypertension, congenital heart disease, kidney failure, or liver cirrhosis are excluded. Participants will wear a wearable device starting about 30 days before surgery and continuing for up to 180 days afterward, with data analyzed remotely. This summary was prepared to help patients understand the study in plain language.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEDevice: 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.