Chest Pain Clinical Trial
Official title:
A Randomized Trial of Telemetry Compared With Unmonitored Floor Admissions in ED Patients With Low-Risk Chest Pain
Verified date | November 2019 |
Source | Vanderbilt University Medical Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | May 2022 |
Est. primary completion date | April 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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) |
Country | Name | City | State |
---|---|---|---|
United States | Vanderbilt University Medical Center | Nashville | Tennessee |
Lead Sponsor | Collaborator |
---|---|
Vanderbilt University Medical Center |
United States,
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. Review. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
* Note: There are 12 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Total hospital resource utilization (costs) | Total cost of the acute hospitalization and use of diagnostic testing and therapies | ED to discharge (approximately 1 to 5 days) | |
Secondary | Inhospital mortality | Death in hospital - binary measurement | ED to discharge (approximately 1 to 5 days) | |
Secondary | Total number of serious dysrhythmias by type | Serious dysrhythmias resulting in defibrillation, cardioversion or acute intravenous (IV) antiarrhythmic/vasoactive therapy | ED to discharge (approximately 1 to 5 days) | |
Secondary | 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) | ED to discharge (approximately 1 to 5 days) | |
Secondary | Number of participants requiring transfer to the Intensive Care Unit (ICU) | Measurement of whether or not a participant was transferred to the ICU | ED to discharge (approximately 1 to 5 days) | |
Secondary | Total hospital and ED length of stay | Total length of stay partitioned by location (ED, monitored bed, unmonitored bed etc.) measured in days | ED to discharge (approximately 1 to 5 days) | |
Secondary | Rapid response team (RRT) call | Dichotomous measure of whether or not the RRT was called and associated with arrhythmia or not | ED to discharge (approximately 1 to 5 days) | |
Secondary | Cardiology consult | Dichotomous measure of whether a cardiology consult was placed and associated with arrhythmia or not | ED to discharge (approximately 1 to 5 days) |
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