Clinical trial NCT03039738: Surveillance Monitoring as an Alternative to Telemetry
Official title: A Prospective Evaluation of Surveillance Monitoring as an Alternative to Telemetry in Patients Scheduled for Telemetry Without American Heart Association (AHA) Indication
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Telemetry
Patient Monitoring
Lead sponsor: Medtronic - MITG
Sponsor class: INDUSTRY
First posted: 2017-02-01
Enrollment: 206
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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

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)

Primary outcomes:
measure: Hospital Length of Stay (LOS) as Assessed by Review of Medical Records
timeFrame: Baseline to end of hospital stay (or up to 30 day post enrollment)
Secondary outcomes:
measure: Associated Health Care Costs (HCC) as Determined by Review of Billing Records
timeFrame: Baseline to end of hospital stay (or up to 30 days post enrollment)
measure: Number of Participants With Hospital Unit Transfers (HUT) as Determined by Review of Medical Records
timeFrame: Baseline to end of hospital stay (or up to 30 days post enrollment)
measure: Length of Stay (LOS) in the ICU as Determined by Review of Medical Records
timeFrame: Baseline to end of hospital stay (or up to 30 days post enrollment)
measure: Number of Participants With Clinical Interventions (CI) as Determined by Review of Medical Records
timeFrame: Baseline to end of hospital stay (or up to 30 days post enrollment)
measure: Time of Rapid Response Team Activation to Time of a Threshold Notification as Measured by the Surveillance Monitoring System Only
timeFrame: Baseline to end of hospital stay (or up to 30 days post enrollment)
measure: Clinical Team and Patient Satisfaction as Measured by Qualitative Questionnaires
timeFrame: Baseline to end of hospital stay (or up to 30 days post enrollment)
measure: Clinicians Familiarity With AHA Guidelines and Telemetry Utilization as Measured by Qualitative Questionnaires
timeFrame: Baseline to end of hospital stay (or up to 30 days post enrollment)
Other outcomes:
Locations:
city: Saint Louis
country: United States
facility: Washington University in Saint Louis
state: Missouri
Study officials:
affiliation: Washington University in Saint Louis
name: Stacey House, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: