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

Not Applicable

Withdrawn

• Conditions: Chest Pain; Resource Utilization; Unstable Angina; Telemetry Usage
• Interventions: Other: Unmonitored; Other: Telemetry

• Registration Number: NCT03906812
• Lead Sponsor: Vanderbilt University Medical Center

Brief Summary

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.

Detailed Description

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2019-04-05
• Study First Submitted QC: 2019-04-05
• Study First Posted: 2019-04-08
• Status Verified: 2019-11
• Last Update Submitted: 2019-11-07
• Last Update Posted: 2019-11-13
• Study Start: 2020-09
• Primary Completion: 2022-04
• Study Completion: 2022-05

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

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

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Exclusion Criteria

• 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)

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Unmonitored floor admission	Unmonitored	Participants in this arm will be admitted to an unmonitored floor bed.
Floor admission with telemetry	Telemetry	Participants in this arm will be admitted to a telemetry bed.

Primary Outcome Measures

Name	Time	Method
Total hospital resource utilization (costs)	ED to discharge (approximately 1 to 5 days)	Total cost of the acute hospitalization and use of diagnostic testing and therapies

Secondary Outcome Measures

Name	Time	Method
Inhospital mortality	ED to discharge (approximately 1 to 5 days)	Death in hospital - binary measurement
Total number of serious dysrhythmias by type	ED to discharge (approximately 1 to 5 days)	Serious dysrhythmias resulting in defibrillation, cardioversion or acute intravenous (IV) antiarrhythmic/vasoactive therapy
Provider reasons for telemetry exclusion	ED to discharge (approximately 1 to 5 days)	Association of reasons for telemetry exclusion, including provider discretion, with subsequent adverse events (e.g. death or serious dysrhythmias resulting in defibrillation, cardioversion or acute IV antiarrhythmic therapy)
Number of participants requiring transfer to the Intensive Care Unit (ICU)	ED to discharge (approximately 1 to 5 days)	Measurement of whether or not a participant was transferred to the ICU
Total hospital and ED length of stay	ED to discharge (approximately 1 to 5 days)	Total length of stay partitioned by location (ED, monitored bed, unmonitored bed etc.) measured in days
Rapid response team (RRT) call	ED to discharge (approximately 1 to 5 days)	Dichotomous measure of whether or not the RRT was called and associated with arrhythmia or not
Cardiology consult	ED to discharge (approximately 1 to 5 days)	Dichotomous measure of whether a cardiology consult was placed and associated with arrhythmia or not

Trial Locations

Locations (1)

Vanderbilt University Medical Center; 🇺🇸 Nashville, Tennessee, United States