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

NCT ID: NCT03906812

Last Updated: 2019-11-13

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-09-30
• Study Completion Date: 2022-05-31

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.

Conditions

Telemetry Usage; Chest Pain; Unstable Angina; Resource Utilization

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: SINGLE

Study Groups

Unmonitored floor admission

Participants in this arm will be admitted to an unmonitored floor bed.

Group Type: ACTIVE_COMPARATOR

Unmonitored

Intervention Type: OTHER

Bed type assignment

Floor admission with telemetry

Participants in this arm will be admitted to a telemetry bed.

Group Type: ACTIVE_COMPARATOR

Telemetry

Intervention Type: OTHER

Bed type assignment

Interventions

Telemetry

Bed type assignment

Intervention Type: OTHER

Unmonitored

Bed type assignment

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

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

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Vanderbilt University Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Sean Collins

Sean Collins, M.D., MSc, Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Sean P Collins, MD

Role: PRINCIPAL_INVESTIGATOR

Vanderbilt University Medical Center

Locations

Vanderbilt University Medical Center

Nashville, Tennessee, United States

Countries

United States

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Other Identifiers

TeleVunmonitored

Identifier Type: -

Identifier Source: org_study_id