Surveillance Monitoring as an Alternative to Telemetry

Medtronic

Status: Terminated

Conditions: Telemetry; Patient Monitoring

Treatments: Device: Vital Sync IM & VPMP (Surveillance Monitoring); Device: Telemetry Monitoring

Study type: Interventional

Funder types: Industry

Identifiers

NCT03039738

COVMOPO0561

Details and patient eligibility

About

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.

Full 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

Enrollment: 206 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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206 participants in 2 patient groups

Telemetry Monitoring Arm

Active Comparator group

Description:

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

Treatment:

Device: Telemetry Monitoring

Surveillance Monitoring Arm

Experimental group

Description:

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

Treatment:

Device: Vital Sync IM & VPMP (Surveillance Monitoring)