An interventional study of Telemetry and Unmonitored in Telemetry Usage, Chest Pain and Unstable Angina, sponsored by Vanderbilt University Medical Center. Withdrawn at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-11-13.
Sponsored by Vanderbilt University Medical Center · Not applicable, Interventional, and Health services research
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.
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.
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Exclusion Criteria:
Participants in this arm will be admitted to an unmonitored floor bed.
Other: Unmonitored
Participants in this arm will be admitted to a telemetry bed.
Other: Telemetry
Bed type assignment
Bed type assignment
Total hospital resource utilization (costs)
Total cost of the acute hospitalization and use of diagnostic testing and therapies
Time frame: ED to discharge (approximately 1 to 5 days)
Inhospital mortality
Death in hospital - binary measurement
Time frame: ED to discharge (approximately 1 to 5 days)
Total number of serious dysrhythmias by type
Serious dysrhythmias resulting in defibrillation, cardioversion or acute intravenous (IV) antiarrhythmic/vasoactive therapy
Time frame: ED to discharge (approximately 1 to 5 days)
Provider reasons for telemetry exclusion
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)
Time frame: ED to discharge (approximately 1 to 5 days)
Number of participants requiring transfer to the Intensive Care Unit (ICU)
Measurement of whether or not a participant was transferred to the ICU
Time frame: ED to discharge (approximately 1 to 5 days)
Total hospital and ED length of stay
Total length of stay partitioned by location (ED, monitored bed, unmonitored bed etc.) measured in days
Time frame: ED to discharge (approximately 1 to 5 days)
Rapid response team (RRT) call
Dichotomous measure of whether or not the RRT was called and associated with arrhythmia or not
Time frame: ED to discharge (approximately 1 to 5 days)
Cardiology consult
Dichotomous measure of whether a cardiology consult was placed and associated with arrhythmia or not
Time frame: ED to discharge (approximately 1 to 5 days)
Plan to share: Yes — Individual participant data that underlie the results reported will be made available (including data dictionaries) after deidentification.
Supporting information: Study protocol, Sap, Analytic code
This study is withdrawn, as verified in Nov 2019. You cannot join it, but the record below documents what was studied.
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Vanderbilt University Medical Center