- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03906812
A Randomized Trial of Telemetry Compared With Unmonitored Floor Admissions in ED Patients With Low-Risk Chest Pain
Study Overview
Status
Intervention / Treatment
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.
Study Type
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Tennessee
-
Nashville, Tennessee, United States, 37232
- Vanderbilt University Medical Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Unmonitored floor admission
Participants in this arm will be admitted to an unmonitored floor bed.
|
Bed type assignment
|
Active Comparator: Floor admission with telemetry
Participants in this arm will be admitted to a telemetry bed.
|
Bed type assignment
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Total hospital resource utilization (costs)
Time Frame: ED to discharge (approximately 1 to 5 days)
|
Total cost of the acute hospitalization and use of diagnostic testing and therapies
|
ED to discharge (approximately 1 to 5 days)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Inhospital mortality
Time Frame: ED to discharge (approximately 1 to 5 days)
|
Death in hospital - binary measurement
|
ED to discharge (approximately 1 to 5 days)
|
Total number of serious dysrhythmias by type
Time Frame: ED to discharge (approximately 1 to 5 days)
|
Serious dysrhythmias resulting in defibrillation, cardioversion or acute intravenous (IV) antiarrhythmic/vasoactive therapy
|
ED to discharge (approximately 1 to 5 days)
|
Provider reasons for telemetry exclusion
Time Frame: 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)
|
ED to discharge (approximately 1 to 5 days)
|
Number of participants requiring transfer to the Intensive Care Unit (ICU)
Time Frame: ED to discharge (approximately 1 to 5 days)
|
Measurement of whether or not a participant was transferred to the ICU
|
ED to discharge (approximately 1 to 5 days)
|
Total hospital and ED length of stay
Time Frame: ED to discharge (approximately 1 to 5 days)
|
Total length of stay partitioned by location (ED, monitored bed, unmonitored bed etc.) measured in days
|
ED to discharge (approximately 1 to 5 days)
|
Rapid response team (RRT) call
Time Frame: ED to discharge (approximately 1 to 5 days)
|
Dichotomous measure of whether or not the RRT was called and associated with arrhythmia or not
|
ED to discharge (approximately 1 to 5 days)
|
Cardiology consult
Time Frame: ED to discharge (approximately 1 to 5 days)
|
Dichotomous measure of whether a cardiology consult was placed and associated with arrhythmia or not
|
ED to discharge (approximately 1 to 5 days)
|
Collaborators and Investigators
Investigators
- Principal Investigator: Sean P Collins, MD, Vanderbilt University Medical Center
Publications and helpful links
General Publications
- Selker HP, Griffith JL, Dorey FJ, D'Agostino RB. How do physicians adapt when the coronary care unit is full? A prospective multicenter study. JAMA. 1987 Mar 6;257(9):1181-5.
- Ward MJ, Eckman MH, Schauer DP, Raja AS, Collins S. Cost-effectiveness of telemetry for hospitalized patients with low-risk chest pain. Acad Emerg Med. 2011 Mar;18(3):279-86. doi: 10.1111/j.1553-2712.2011.01008.x.
- Sandau KE, Funk M, Auerbach A, Barsness GW, Blum K, Cvach M, Lampert R, May JL, McDaniel GM, Perez MV, Sendelbach S, Sommargren CE, Wang PJ; American Heart Association Council on Cardiovascular and Stroke Nursing; Council on Clinical Cardiology; and Council on Cardiovascular Disease in the Young. Update to Practice Standards for Electrocardiographic Monitoring in Hospital Settings: A Scientific Statement From the American Heart Association. Circulation. 2017 Nov 7;136(19):e273-e344. doi: 10.1161/CIR.0000000000000527. Epub 2017 Oct 3.
- Goldman L, Weinberg M, Weisberg M, Olshen R, Cook EF, Sargent RK, Lamas GA, Dennis C, Wilson C, Deckelbaum L, Fineberg H, Stiratelli R. A computer-derived protocol to aid in the diagnosis of emergency room patients with acute chest pain. N Engl J Med. 1982 Sep 2;307(10):588-96. doi: 10.1056/NEJM198209023071004.
- Hollander JE, Valentine SM, McCuskey CF, Brogan GX Jr. Are monitored telemetry beds necessary for patients with nontraumatic chest pain and normal or nonspecific electrocardiograms? Am J Cardiol. 1997 Apr 15;79(8):1110-1. doi: 10.1016/s0002-9149(97)00057-x.
- Snider A, Papaleo M, Beldner S, Park C, Katechis D, Galinkin D, Fein A. Is telemetry monitoring necessary in low-risk suspected acute chest pain syndromes? Chest. 2002 Aug;122(2):517-23. doi: 10.1378/chest.122.2.517.
- Schull MJ, Redelmeier DA. Continuous electrocardiographic monitoring and cardiac arrest outcomes in 8,932 telemetry ward patients. Acad Emerg Med. 2000 Jun;7(6):647-52. doi: 10.1111/j.1553-2712.2000.tb02038.x.
- Reaney PDW, Elliott HI, Noman A, Cooper JG. Risk stratifying chest pain patients in the emergency department using HEART, GRACE and TIMI scores, with a single contemporary troponin result, to predict major adverse cardiac events. Emerg Med J. 2018 Jul;35(7):420-427. doi: 10.1136/emermed-2017-207172. Epub 2018 Apr 5.
- Estrada CA, Prasad NK, Rosman HS, Young MJ. Outcomes of patients hospitalized to a telemetry unit. Am J Cardiol. 1994 Aug 15;74(4):357-62. doi: 10.1016/0002-9149(94)90403-0.
- Estrada CA, Rosman HS, Prasad NK, Battilana G, Alexander M, Held AC, Young MJ. Role of telemetry monitoring in the non-intensive care unit. Am J Cardiol. 1995 Nov 1;76(12):960-5. doi: 10.1016/s0002-9149(99)80270-7.
- Hollander JE, Sites FD, Pollack CV Jr, Shofer FS. Lack of utility of telemetry monitoring for identification of cardiac death and life-threatening ventricular dysrhythmias in low-risk patients with chest pain. Ann Emerg Med. 2004 Jan;43(1):71-6. doi: 10.1016/s0196-0644(03)00719-4.
- Lee TH, Juarez G, Cook EF, Weisberg MC, Rouan GW, Brand DA, Goldman L. Ruling out acute myocardial infarction. A prospective multicenter validation of a 12-hour strategy for patients at low risk. N Engl J Med. 1991 May 2;324(18):1239-46. doi: 10.1056/NEJM199105023241803.
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- TeleVunmonitored
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- Study Protocol
- Statistical Analysis Plan (SAP)
- Analytic Code
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Chest Pain
-
Clinical Locomotion ScienceOdense University Hospital; University of Southern Denmark; The County of Funen... and other collaboratorsCompletedUndiagnosed Chest Pain | Musculoskeletal Chest Pain | Non-cardiac Chest PainDenmark
-
Academisch Medisch Centrum - Universiteit van Amsterdam...TerminatedFunctional Chest PainNetherlands
-
Atatürk UniversityCompletedPain, Acute | Pain, ChestTurkey
-
Queen's UniversityCompletedChest Pain Atypical SyndromeCanada
-
Universiti Sains MalaysiaCompletedNon Cardiac Chest PainMalaysia
-
Milton S. Hershey Medical CenterCompletedNoncardiac Chest Pain (NCCP)United States
-
Cairo UniversityActive, not recruitingNonspecific Cardiac Chest PainEgypt
-
Fayoum University HospitalCompleted
-
University of Texas Southwestern Medical CenterCompletedAcute Chest PainUnited States
-
Massachusetts General HospitalBracco Diagnostics, IncCompletedChest Pain SyndromeUnited States