Clinical trial NCT04824066: The Role of Wearable Devices in Cardiothoracic Surgery: Predicting and Detecting Early Postoperative Complications
Official title: The Role of Wearable Devices in Cardiothoracic Surgery: Predicting and Detecting Early Postoperative Complications
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Surgery--Complications
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
Collaborators: name: Case Western Reserve University
First posted: 2021-04-01
Enrollment: 1200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients undergoing cardiothoracic surgery that are amenable to wearing a device of interest and meet the inclusion and exclusion criteria above will be approached for informed consent.

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 complications at their earliest stage

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 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.

Eligibility 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

Primary outcomes:
measure: Early detection of postoperative complications using machine learning analysis of patient biometric data.
timeFrame: Four Years
measure: Prediction of the quality of postoperative recovery using pre- and intraoperative data.
timeFrame: Four Years
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Chi-Fu Jeffrey Yang
role: PRINCIPAL_INVESTIGATOR
References: