Remote Monitoring to Improve Physician Monitoring, Patient Satisfaction, and Predict Readmissions Following Surgery

Remote Monitoring Clinical Trial

Official title:

Use of Remote Monitoring to Improve Physician Monitoring, Patient Satisfaction, and Predict Readmissions Following Cardiac Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03800329
• Other study ID #: 17-008249
• Status: Completed
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Remote Monitoring

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

External Links

•   Mayo Clinic Clinical Trials