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临床试验/NCT03906812
NCT03906812撤回不适用

A Randomized Trial of Telemetry Compared With Unmonitored Floor Admissions in ED Patients With Low-Risk Chest Pain

Vanderbilt University Medical Center2 个研究点 分布在 1 个国家开始时间: 2020年9月最近更新:
适应症

试验速览

阶段
不适用
状态
撤回
试验地点
2
主要终点
Total hospital resource utilization (costs)

研究概览

简要总结

This study aims to determine, relative to telemetry admission, if admission to an unmonitored floor bed saves resources without an increased rate of adverse events in emergency department (ED) patients admitted with chest pain and low-risk features.

详细描述

Many patients admitted to the hospital with concern for cardiopulmonary and other acute illnesses are routinely placed on electrocardiographic monitoring (telemetry). Telemetry surveillance theoretically allows the clinical staff to monitor admitted patients for the development of both brady- and tachydysrhythmias. The goal is to identify dysrhythmias immediately via active cardiac monitoring in the very few patients who develop them, rather than identifying the dysrhythmia after the patient becomes symptomatic. However, the overwhelming majority (greater than 99 percent) of monitored patients do not experience any significant arrhythmia. The liberal use of monitoring in unnecessary situations may give the hospital staff a false sense of security and/or desensitize them to alarms. Studies also suggest the liberal use of telemetry inflates costs and clogs telemetry beds with little potential for benefit. These findings have contributed to the American Heart Association's statement that telemetry is of no benefit in patients with chest pain who are clinically low-risk or who are awake and alert and can describe their angina. Importantly, previous findings provide a foundation for identifying patients that do not need to undergo monitoring, but no study to date has rigorously prospectively applied these criteria in a randomized trial to determine the impact of selective telemetry utilization on clinical care and resources.

This study is a pragmatic, randomized, controlled trial of telemetry compared with unmonitored floor admissions in ED patients with low-risk chest pain. The primary aim is to determine, relative to telemetry admission, if admission to an unmonitored floor bed saves resources without an increased rate of adverse events in ED patients admitted with chest pain and low-risk features. In addition, the study will evaluate the effects of the same intervention in the same population on secondary outcomes including defibrillation, cardioversion or acute IV antiarrhythmic/vasoactive therapy. Finally, the study will associate reasons for telemetry exclusion, including provider discretion, with subsequent adverse events.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
Single (Outcomes Assessor)

盲法说明

The study statistician will be blinded to study arm assignment.

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Adult ED patients admitted to the medical service at Vanderbilt University Medical Center with chest pain and low-risk clinical features.

排除标准

  • Age less than 18 years
  • Chest pain patients admitted to the ICU
  • Patients with sickle cell disease
  • Chest pain patients with high-risk electrocardiogram (ECG) criteria:
  • abnormal but non-diagnostic of myocardial ischemia (prolonged PR, QRS, QTc intervals, new bundle branch blocks, left ventricular hypertrophy with strain)
  • ischemia or prior infarction
  • suggestive of acute myocardial infarction
  • A positive troponin at any time during the current evaluation (above the 99 percent reference limit, greater than 0.03 nanograms per milliliter)
  • Patients whom the admitting team feels has another non-low-risk indication for telemetry (e.g. acute heart failure, syncope with features concerning for a cardiac etiology, other arrhythmia)

结局指标

主要结局

Total hospital resource utilization (costs)

时间窗: ED to discharge (approximately 1 to 5 days)

Total cost of the acute hospitalization and use of diagnostic testing and therapies

次要结局

  • Rapid response team (RRT) call(ED to discharge (approximately 1 to 5 days))
  • Total hospital and ED length of stay(ED to discharge (approximately 1 to 5 days))
  • Inhospital mortality(ED to discharge (approximately 1 to 5 days))
  • Total number of serious dysrhythmias by type(ED to discharge (approximately 1 to 5 days))
  • Provider reasons for telemetry exclusion(ED to discharge (approximately 1 to 5 days))
  • Number of participants requiring transfer to the Intensive Care Unit (ICU)(ED to discharge (approximately 1 to 5 days))
  • Cardiology consult(ED to discharge (approximately 1 to 5 days))

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Sean Collins

Sean Collins, M.D., MSc, Professor

Vanderbilt University Medical Center

研究点 (2)

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