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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

1200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-07-10

Study Completion Date

2027-06-30

Brief Summary

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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

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Detailed Description

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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.

Conditions

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Surgery--Complications

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Cardiothoracic Surgery Cohort

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

Device: Wearable Device

Intervention Type 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.

Interventions

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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.

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No