Surveillance Monitoring as an Alternative to Telemetry

NCT ID: NCT03039738

Last Updated: 2019-05-13

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 206 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-04-03
• Study Completion Date: 2018-01-04

Brief Summary

The purpose of the study is to evaluate the impact of surveillance monitoring versus telemetry monitoring on clinical, healthcare economics, resource utilization, and qualitative outcomes.

Detailed Description

This will be single-center, prospective, pilot, pre/post implementation study to collect post-market data on hospitalized subjects monitored via telemetry and surveillance monitoring

Conditions

Telemetry; Patient Monitoring

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Telemetry Monitoring Arm

The telemetry group will serve as the control group and will be monitored via the site's standard of care telemetry protocols.

Group Type: ACTIVE_COMPARATOR

Telemetry Monitoring

Intervention Type: DEVICE

Continuous ECG monitoring for hospitalized patients at-risk for cardiac events.

Surveillance Monitoring Arm

Subjects in the surveillance monitoring group will alternatively be admitted to medical surgical unit and be monitored via the surveillance monitoring platform.

Group Type: EXPERIMENTAL

Vital Sync IM & VPMP (Surveillance Monitoring)

Intervention Type: DEVICE

The Vital Sync™ Informatics Manager (IM) \& Virtual Patient Monitoring Platform (VPMP) is an electronic medical record connectivity and remote continuous patient monitoring software solution.

Interventions

Vital Sync IM & VPMP (Surveillance Monitoring)

The Vital Sync™ Informatics Manager (IM) \& Virtual Patient Monitoring Platform (VPMP) is an electronic medical record connectivity and remote continuous patient monitoring software solution.

Intervention Type: DEVICE

Telemetry Monitoring

Continuous ECG monitoring for hospitalized patients at-risk for cardiac events.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

1. Signed and dated informed consent by subject

2. Male or female 18 years of age or older

3. Expected hospitalized admission on the general care floor or medical surgical unit for at least one overnight stay and/or > 12 hours

4. Scheduled for telemetry monitoring

5. Diagnosis indicates American Heart Association (AHA) telemetry Class III or none and therefore not indicated for telemetry monitoring

6. For surveillance monitoring group subjects, treating provider who scheduled subject for telemetry agrees to alternative monitoring plan of surveillance monitoring

7. Willingness to have study devices attached and hair shaved at sensor location as needed during study participation

8. Willingness to participate in all aspects of the study

Exclusion Criteria

1. Implanted pacemaker or atrial defibrillator

2. Allergy or sensitivity to ECG leads or adhesives that are similar to ECG leads

3. Current AHA Class I or II indication/prescription for telemetry monitoring

4. Prescription for other continuous condition monitoring such as capnography or pulse oximetry

5. Ongoing opioid therapy by patient-controlled analgesia (PCA), by epidural or intrathecal infusions or by intravenous analgesia, per Investigator discretion

6. Ventilated or intubated patients at the time of enrollment

7. Female subject is pregnant, lactating, trying to get pregnant, or has a positive pregnancy test for women with childbearing potential

8. Condition that, in the opinion of the investigator, may prevent completion of the study or protocol requirements

9. Subject is considered as being morbidly obese (defined as BMI >50.0)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medtronic - MITG

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Stacey House, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Washington University in Saint Louis

Locations

Washington University in Saint Louis

St Louis, Missouri, United States

Countries

United States

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

COVMOPO0561

Identifier Type: -

Identifier Source: org_study_id