Status:

RECRUITING

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

Lead Sponsor:

Massachusetts General Hospital

Collaborating Sponsors:

Case Western Reserve University

Conditions:

Surgery--Complications

Eligibility:

All Genders

18+ years

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 com...

Detailed 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 sur...

Eligibility Criteria

Inclusion

  • 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

Exclusion

  • 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

Key Trial Info

Start Date :

July 10 2021

Trial Type :

OBSERVATIONAL

Allocation :

ESTIMATED

End Date :

June 30 2027

Estimated Enrollment :

1200 Patients enrolled

Trial Details

Trial ID

NCT04824066

Start Date

July 10 2021

End Date

June 30 2027

Last Update

December 10 2025

Active Locations (1)

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Page 1 of 1 (1 locations)

1

Massachusetts General Hospital

Boston, Massachusetts, United States, 02114

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