Arrhythmias, CardiacNCT02466633
Effect of Monitoring System Design on Response Time to Cardiac Arrhythmias
A study testing In-hospital cardiac monitoring method in people with Arrhythmias, Cardiac, run by Duke University.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Arrhythmias, Cardiac
- What is being tested?
- In-hospital cardiac monitoring method
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 250 participants
- Where
- No sites listed yet
- Study dates
- Sep 2015to 26 Feb 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- NA
About this study
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.
Read the detailed 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:
- 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.
- 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.
- 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.
- Conditions
- Arrhythmias, Cardiac
- Being tested
- In-hospital cardiac monitoring method
- Medical subject headings
- Arrhythmias, Cardiac
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
In-hospital cardiac monitoring methodOther
Method for monitoring hospitalized patients at risk for cardiac arrhythmias (non-ICU)
| Study group | Role | What they receive |
|---|---|---|
| Change in in-hospital cardiac monitoring method | Experimental | Pre- and post-intervention, where the intervention is a change in in-hospital cardiac monitoring method Receives: Other: In-hospital cardiac monitoring method |
What is being measured
The primary outcome is the main question the study is designed to answer.
Response time to a simulated (not real) critical cardiac arrhythmia (pulseless ventricular tachycardia or ventricular fibrillation)
Measured: After critical arrhythmia is simulated (approximately 1-5 minutes)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2015 (estimated)
- Study startSep 2015
- Primary completion26 Feb 2020
- Study completion26 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Arrhythmias, CardiacStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 250 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Collaborators
- Agency for Healthcare Research and Quality (AHRQ)
- Responsible party
- Sponsor
- Investigators
- Noa Segall, PhD, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02466633
- Sponsor's protocol ID
- Pro00053941
- Other IDs
- 1R01HS023387-01
- Status last verified
- May 2021
- First submitted
- 3 Jun 2015
- Last updated
- 1 Jun 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Monitoring System Design on Response Time to Cardiac Arrhythmias
- ClinicalTrials.gov ID
- NCT02466633
- Acronym / sponsor ID
- Pro00053941
- Conditions
- Arrhythmias, Cardiac
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 250 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Collaborators
- Agency for Healthcare Research and Quality (AHRQ)
- Study start
- Sep 2015 (actual)
- Primary completion
- 26 Feb 2020 (actual)
- Study completion
- 26 Feb 2020 (actual)
- First posted
- 9 Jun 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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:
- 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.
- 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.
- 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.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Change in in-hospital cardiac monitoring method | Experimental | Other: In-hospital cardiac monitoring methodPre- and post-intervention, where the intervention is a change in in-hospital cardiac monitoring method |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (1 listed)
- NA
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| In-hospital cardiac monitoring methodMethod for monitoring hospitalized patients at risk for cardiac arrhythmias (non-ICU) | Other | Change in in-hospital cardiac monitoring method |
Primary outcome
Response time to a simulated (not real) critical cardiac arrhythmia (pulseless ventricular tachycardia or ventricular fibrillation)
Time frame: After critical arrhythmia is simulated (approximately 1-5 minutes)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2021.
Related trials for Arrhythmias, Cardiac
RecruitingObservational study
AI-powered ECG Analysis Using Willem™ Software in High-risk Cardiac Patients (WILLEM)
Cardiomyopathies, Cardiac Arrest
Not yet recruiting
nCPAP-NAVA-Backup Versus Standard nCPAP for Severe Apnea in Preterm Infants ≤28 Weeks
Apnea of Prematurity
Active, not recruiting
Horizon 360 Protocol for the Treatment of Paroxysmal Atrial Fibrillation With the Sphere-360™ Catheter and Affera™ Mapping and Ablation System (Horizon 360)
Paroxysmal AF
Not yet recruiting
Smartphone Camera Measurement of Breathing-Related Heart Rate Variability Compared With ECG in Healthy Adults
Respiratory Sinus Arrhythmia, Heart Rate Variability
Active, not recruitingObservational study
Concomitant Left Atrial Appendage Closure and Pulsed Field Ablation-Asia
Concomitant Procedures, Atrial Fibrillation
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Noa Segall, PhD principal investigator
Duke University
Questions about this trial
What is this clinical trial studying?
A study testing In-hospital cardiac monitoring method in people with Arrhythmias, Cardiac, run by Duke University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Response time to a simulated (not real) critical cardiac arrhythmia (pulseless ventricular tachycardia or ventricular fibrillation) (time frame: After critical arrhythmia is simulated (approximately 1-5 minutes)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jun 2021.