Using wearable devices to predict and detect complications after heart surgery
The Role of Wearable Devices in Cardiothoracic Surgery: Predicting and Detecting Early Postoperative Complications
This study is testing if wearable devices can help doctors spot problems early in patients recovering from heart surgery by tracking their activity and sleep.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 1200 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Massachusetts General Hospital Academic / other |
| Locations | 1 site (Boston, Massachusetts) |
| Trial ID | NCT04824066 on ClinicalTrials.gov |
What this trial studies
This research aims to utilize machine learning analysis of data collected from wearable devices to monitor recovery and identify early postoperative complications in patients undergoing cardiothoracic surgery. The study will enroll patients who will wear a device like a Fitbit from approximately 30 days before surgery until 180 days after. The data collected will include activity levels and sleep quality, which will be analyzed to improve patient outcomes. The study is non-randomized and will involve a single center, Massachusetts General Hospital, with a target enrollment of 1,200 subjects.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older who are undergoing cardiothoracic surgery and can use wearable devices.
Not a fit: Patients with severe irreversible pulmonary hypertension, congenital heart disease, chronic renal insufficiency, liver cirrhosis, or those who are pregnant may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to earlier detection of complications, improving recovery outcomes for patients after cardiothoracic surgery.
How similar studies have performed: While the use of wearable devices in postoperative monitoring is gaining traction, this specific application in cardiothoracic surgery is relatively novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Boston, Massachusetts
- Massachusetts General Hospital — Boston, Massachusetts, United States (Recruiting)
Study contacts
- Principal investigator: Chi-Fu Jeffrey Yang — Massachusetts General Hospital
- Study coordinator: Chi-Fu Jeffrey Yang, MD
- Email: cjyang@mgh.harvard.edu
- Phone: 617-726-5200
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.