Surveillance Monitoring as an Alternative to Telemetry

NCT03039738 | Terminated Results FDA Device

• 1 other identifier: COVMOPO0561
• Study Type: interventional
• Target: 206
• Locations: 1 country
• Sites: 1

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.

Conditions

Telemetry; Patient Monitoring

Outcome Measures

Primary Outcomes (1)

• Hospital Length of Stay (LOS) as Assessed by Review of Medical Records

  LOS will be determined by comparing LOS Between the Surveillance Monitoring and Telemetry Monitoring Period Arms.

  Baseline to end of hospital stay (or up to 30 day post enrollment)

Secondary Outcomes (7)

• Associated Health Care Costs (HCC) as Determined by Review of Billing Records

  Baseline to end of hospital stay (or up to 30 days post enrollment)

• Number of Participants With Hospital Unit Transfers (HUT) as Determined by Review of Medical Records

  Baseline to end of hospital stay (or up to 30 days post enrollment)

• Length of Stay (LOS) in the ICU as Determined by Review of Medical Records

  Baseline to end of hospital stay (or up to 30 days post enrollment)

• Number of Participants With Clinical Interventions (CI) as Determined by Review of Medical Records

  Baseline to end of hospital stay (or up to 30 days post enrollment)

• Time of Rapid Response Team Activation to Time of a Threshold Notification as Measured by the Surveillance Monitoring System Only

  Baseline to end of hospital stay (or up to 30 days post enrollment)

Study Arms (2)

Telemetry Monitoring Arm

ACTIVE COMPARATOR

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

Device: Telemetry Monitoring

Surveillance Monitoring Arm

EXPERIMENTAL

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

Device: Vital Sync IM & VPMP (Surveillance Monitoring)

Interventions

Vital Sync IM & VPMP (Surveillance Monitoring) 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.

Surveillance Monitoring Arm

Telemetry Monitoring DEVICE

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

Telemetry Monitoring Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Signed and dated informed consent by subject
• Male or female 18 years of age or older
• Expected hospitalized admission on the general care floor or medical surgical unit for at least one overnight stay and/or \> 12 hours
• Scheduled for telemetry monitoring
• Diagnosis indicates American Heart Association (AHA) telemetry Class III or none and therefore not indicated for telemetry monitoring
• For surveillance monitoring group subjects, treating provider who scheduled subject for telemetry agrees to alternative monitoring plan of surveillance monitoring
• Willingness to have study devices attached and hair shaved at sensor location as needed during study participation
• Willingness to participate in all aspects of the study

You may not qualify if:

• Implanted pacemaker or atrial defibrillator
• Allergy or sensitivity to ECG leads or adhesives that are similar to ECG leads
• Current AHA Class I or II indication/prescription for telemetry monitoring
• Prescription for other continuous condition monitoring such as capnography or pulse oximetry
• Ongoing opioid therapy by patient-controlled analgesia (PCA), by epidural or intrathecal infusions or by intravenous analgesia, per Investigator discretion
• Ventilated or intubated patients at the time of enrollment
• Female subject is pregnant, lactating, trying to get pregnant, or has a positive pregnancy test for women with childbearing potential
• Condition that, in the opinion of the investigator, may prevent completion of the study or protocol requirements
• Subject is considered as being morbidly obese (defined as BMI \>50.0)

Sponsors & Collaborators

• Medtronic - MITG: lead

Study Sites (1)

Washington University in Saint Louis

St Louis, Missouri, 63130, United States

Location

Limitations and Caveats

This study was terminated early, no conclusions should be drawn from the data.

Results Point of Contact

• Title: Anne Kinney
• Organization: Medtronic

anne.r.kinney@medtronic.com

+1-303-876-8904

Study Officials

• Stacey House, MD, PhD

  Washington University in Saint Louis

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 30, 2017
• First Posted: February 1, 2017
• Study Start: April 3, 2017
• Primary Completion: January 4, 2018
• Study Completion: January 4, 2018
• Last Updated: May 13, 2019
• Results First Posted: April 29, 2019

Record last verified: 2019-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)