NCT03039738终止不适用
A Prospective Evaluation of Surveillance Monitoring as an Alternative to Telemetry in Patients Scheduled for Telemetry Without American Heart Association (AHA) Indication
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 206
- 试验地点
- 2
- 主要终点
- Hospital Length of Stay (LOS) as Assessed by Review of Medical Records
研究概览
简要总结
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.
详细描述
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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)
研究组 & 干预措施
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.
干预措施: Telemetry Monitoring (Device)
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.
干预措施: Vital Sync IM & VPMP (Surveillance Monitoring) (Device)
结局指标
主要结局
Hospital Length of Stay (LOS) as Assessed by Review of Medical Records
时间窗: Baseline to end of hospital stay (or up to 30 day post enrollment)
LOS will be determined by comparing LOS Between the Surveillance Monitoring and Telemetry Monitoring Period Arms.
次要结局
- 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))
- Clinical Team and Patient Satisfaction as Measured by Qualitative Questionnaires(Baseline to end of hospital stay (or up to 30 days post enrollment))
- Clinicians Familiarity With AHA Guidelines and Telemetry Utilization as Measured by Qualitative Questionnaires(Baseline to end of hospital stay (or up to 30 days post enrollment))
研究者
研究点 (2)
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