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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03800329
Other study ID # 17-008249
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date March 7, 2018
Est. completion date October 26, 2021

Study information

Verified date November 2021
Source Mayo Clinic
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This study is designed to determine the perceived value of continuous remote monitoring to surgeons and surgical patients at Mayo Clinic in Rochester, MN, and determine whether algorithms can be generated to predict risk of readmission following discharge. This initial study will be conducted through the Department of Cardiovascular Surgery.


Description:

The overall aim of this project is to determine the perceived utility and benefit to use of remote monitoring technology in patients being discharged following cardiac surgery at Mayo Clinic in Rochester, MN. The investigators also aim to determine whether machine learning algorithms can predict readmission following cardiac surgery in these patients, which the investigators believe will benefit patients in future studies.


Recruitment information / eligibility

Status Completed
Enrollment 50
Est. completion date October 26, 2021
Est. primary completion date October 26, 2021
Accepts healthy volunteers No
Gender All
Age group 40 Years and older
Eligibility Target accrual: 100 patients Subject population (children, adults, groups): adults undergoing coronary bypass surgery at Mayo Clinic in Rochester, MN Inclusion Criteria: - Patients undergoing isolated coronary artery bypass graft (CABG) surgery - Must be undergoing the procedure at Mayo Clinic in Rochester, MN - Must be greater than or equal to 40 years of age Exclusion Criteria: - Under 40 years of age - Concomitant additional surgical procedure (e.g., CABG + valve replacement) - Patients with implantable pacemakers/defibrillators - Patients that find the device too uncomfortable to wear for 48 hours

Study Design


Related Conditions & MeSH terms


Intervention

Device:
Snap40 Monitor
Non-invasive, wearable armband device used to measure change in systolic blood pressure, respiratory rate, heart rate, body temperature, movement, and oxyhemoglobin saturation and streams this information to a cloud-based storage system. Patients will complete a questionnaire.
Other:
No Monitor
Patients will be discharged in the ordinary manner, without the Snap40 monitor. Patients will complete a questionnaire.

Locations

Country Name City State
United States Mayo Clinic in Rochester Rochester Minnesota

Sponsors (2)

Lead Sponsor Collaborator
Mayo Clinic Snap40 Ltd.

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Other Algorithms useful in prediction of readmission following cardiac surgery Measure data collected via machine learning algorithms to predict readmission following cardiac surgery in patients. 48 hours
Primary Physician satisfaction in the use of remote monitoring technology. Physician satisfaction survey measure the utility and benefit to the use of remote monitoring technology in patients being discharged following cardiac surgery at Mayo Clinic in Rochester, MN. 48 hours
Secondary Patient satisfaction in the use of remote monitoring technology. Patient satisfaction survey measures the utility and benefit to the use of remote monitoring technology in patients being discharged following cardiac surgery at Mayo Clinic in Rochester, MN. 48 hours
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