Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02466633
Other study ID # Pro00053941
Secondary ID 1R01HS023387-01
Status Completed
Phase N/A
First received
Last updated
Start date September 2015
Est. completion date February 26, 2020

Study information

Verified date May 2021
Source Duke University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

To increase the potential for timely detection and treatment of cardiac events, hospitals have implemented a number of different cardio-respiratory monitoring methods for at-risk patients. The goal of this study is to compare different monitoring methods to determine the most efficient method to monitor hospitalized patients - the method that will lead to the quickest response to critical heart rhythms. The investigators will then test the efficiency of this monitoring method by implementing it in a new patient care unit.


Description:

Most patients in the hospital who are at lower risk for developing abnormal heart rhythms have their vitals signs (e.g., heart rate, blood pressure) measured intermittently, such as every 8 hours. In contrast, hospitalized patients who are at risk for cardiac arrest and other arrhythmias are put on telemetry to continuously monitor their heart rhythm. A telemetry monitor is a portable box that is attached to the patient's ECG leads and displays his or her heart rate and rhythm at a central station. The monitor sends an alarm when it detects an abnormal rhythm, notifying the person monitoring the patient to check on the patient. Monitor watchers are dedicated nurses or technicians who monitor a bank of displays . The watcher-to-patient ratio varies among hospitals, with a single watcher monitoring between 16 and 72 patients at one time. There are also variations in the additional tasks assigned to watchers, communication modalities between watchers and nurses (e.g., pagers, overhead speakers, landline and cell phones, or bi-directional voice communication badges), and alarm presentation to nurses (e.g., via bedside monitors, centrally located monitors, automated phone notifications, or none at all, relying on telemetry watchers for notifications). A quick and efficient response to cardiac arrest is critical in order to increase the patient's chance of survival. There is a need for a better understanding of the impact on monitoring efficiency of factors such as the workload of monitor watchers, communication methods, and supportive technologies including alarms and automated notification systems. The objective of the proposed research is to identify and test determinants of efficient cardiac monitoring methods. There are 3 phases to the study: 1. Characterize candidate monitoring methods (Phase 1). The investigators will study usual care for monitored patients in 6 hospital units. As part of their usual care these units have different monitoring methods. These methods vary in terms of 1) the location of the monitor watchers, 2) the means of communicating routine and life-threatening events (e.g., via pagers), and 3) monitor watchers' patient load and workload. For each of these 6 units, the investigators will collect data through interviews, observations, and 20 cardiac arrest simulations. 2. Determine which monitoring method leads to consistently rapid response times to lethal arrhythmias (Phase 2). Using interview, observation, and simulation data collected in Phase 1, the investigators will develop a computer simulation model of each of the 6 monitoring methods that will allow them to identify the most efficient method. 3. Test a new monitoring method (Phase 3). In one of the units we had previously conducted arrhythmia simulations, we will conduct 20 additional simulations after a change from remote telemetry monitoring to local nurse-based monitoring. We will evaluate whether response times decrease with the new monitoring method.


Recruitment information / eligibility

Status Completed
Enrollment 250
Est. completion date February 26, 2020
Est. primary completion date February 26, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Care providers including the individuals responsible for monitoring patients (monitoring technicians and nurses), individuals communicating life threatening events (monitoring technicians, health unit coordinators, and nurses) and the individuals responsible for the initial check on a patient in the event of life-threatening cardiac arrhythmias (generally the patient's nurse). - Patients for whom cardiac monitoring was ordered by their physician. Exclusion Criteria: - NA

Study Design


Related Conditions & MeSH terms


Intervention

Other:
In-hospital cardiac monitoring method
Method for monitoring hospitalized patients at risk for cardiac arrhythmias (non-ICU)

Locations

Country Name City State
n/a

Sponsors (2)

Lead Sponsor Collaborator
Duke University Agency for Healthcare Research and Quality (AHRQ)

Outcome

Type Measure Description Time frame Safety issue
Primary Response time to a simulated (not real) critical cardiac arrhythmia (pulseless ventricular tachycardia or ventricular fibrillation) After critical arrhythmia is simulated (approximately 1-5 minutes)
See also
  Status Clinical Trial Phase
Completed NCT03079726 - Use of Device Data to Predict Frailty in Individuals
Recruiting NCT06014996 - Comparison of PFA vs. RFA in Patients With Symptomatic Paroxysmal Atrial Fibrillation. N/A
Recruiting NCT04092985 - Smart Watch iECG for the Detection of Cardiac Arrhythmias
Completed NCT05404789 - Tolerance of Centrifuge-induced Acceleration in Subjects With Diabetes Mellitus and Cardiac Arrhythmia N/A
Recruiting NCT04554160 - Arrhythmias in Pulmonary Hypertension Assessed by Continuous Long-term Cardiac Monitoring
Recruiting NCT04471584 - Comparative Analysis in Detection of Atrial Arrhythmia and ECG Quality in Three Different Insertable Cardiac Monitors N/A
Recruiting NCT02906189 - Safety of Magnetic Resonance Imaging in Non-MRI Conditional Pacemakers and ICD Devices N/A
Completed NCT02550340 - Munich Study for Beer Related ECG Change Workup N/A
Completed NCT01871090 - Remote Device Interrogation In The Emergency Department N/A
Completed NCT04884100 - enHEART - Exploring Full Content of Optical Signals to Enhance Cardiac Arrhythmia Screening N/A
Withdrawn NCT04556240 - RECORD-VP: Real-time Evaluation of Cardiac Outpatient Recording Device With VitalPatch RTM
Active, not recruiting NCT05481359 - AF-FLOW Registry: This Study is to Evaluate Ablamap Software in Patients Undergoing Ablation for Atrial Fibrillation.
Recruiting NCT05047835 - Comparison of Prone Position and Standard Electrocardiogram in COVID-19 Patients
Not yet recruiting NCT05974306 - Evaluation of a Proactive Clinical Management and Early Diagnosis of Arrhythmias in Patients With Heart Failure and Non Severely Reduced Left Ventricular Function Through a Telemonitoring System N/A
Not yet recruiting NCT05957315 - Mobile Cardiac Outpatient Telemetry for Unexplained Syncope N/A
Completed NCT06260670 - FLOW EVAL-AF: FLOW Mapping Electrogram VALidation in Patients With Persistent Atrial Fibrillation N/A
Active, not recruiting NCT04876963 - HOLT-ED: Holter-monitoring in End-stage Renal Disease
Completed NCT04943354 - Associations of Combinations of Single-nucleotide Polymorphisms in Women With Premature Ovarian Failure N/A
Recruiting NCT03857711 - Randomized Clinical Trial PULVAB (Prophylactic Pulmonary Veins Ablation) N/A
Recruiting NCT04869527 - Full Early Atrial Diagnostics in Single Chamber ICD Patients Using the DX Lead and Home Monitoring in Brazil.