Bradycardia, Difficulty Breathing, Shortness of Breath Episode, Tachycardia
Conditions
Keywords
Cariopulmonary, cardiac arrest
Brief summary
Prospective observational clinical study to verify an algorithm used to predict cardiopulmonary events in patients presenting to the emergency department.
Detailed description
A novel algorithm for determining risk of acute cardiac complications, including cardiac arrest, for patients presenting to the ED has recently been reported. Unlike prior risk stratification tools that relied on basic vital sign data, this algorithm utilizes advanced computing of ECG data to solve the risk classification problem. Data will be collected on patients presenting to the emergency department with a primary complaint that is determined to be cardiopulmonary of origin by a clinician. Verification of the results of the previous studies using this algorithm in a more diverse patient cohorts is required. As such, the proposed study will investigate the accuracy of the algorithm.
Interventions
None listed
Sponsors
Zoll Medical Corporation
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
18 years of age or older Admission to emergency department requiring immediate medical attention due to presumed cardiac or pulmonary cause(s) and considered 2nd or 3rd tier priority in triage system.
Exclusion criteria
Pregnant or suspected pregnancy Significant trauma Do Not Resuscitate order Known as Ward of the State
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Subjects With a Cardiopulmonary Event | Within 72 hours of presentation to ED | The number of any cardiopulmonary event, not limited to: Cardiac arrest Sustained ventricular tachycardia (VT) Hypotension requiring inotropes or intra-aortic balloon pump (IABP) insertion Intubation or mechanical ventilation Complete heart block Bradycardia requiring insertion of a pacing wire or external pacing, and Percutaneous coronary intervention (PCI) or coronary artery bypass surgery (CABG) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Cumulative Number of Cardiopulmonary Events in a Single Subject | Within 72 hours of presentation to ED | The cumulative number of any cardiac and cardiac-related events, not limited to: In-hospital Death In-hospital Cardiac Arrest Composite cardiovascular outcome or intervention (Lethal Arrhythmias , Acute Pulmonary Edema, Cardiogenic Shock, Myocardial Infarction, Percutaneous Coronary Intervention, Coronary artery Bypass Surgery , New or Recurrent MI, Recurrent Ischemia requiring Revascularization) |
Countries
Belgium, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Enrolled Enrolled subjects in observational study | 673 |
| Total | 673 |
Baseline characteristics
| Characteristic | Enrolled |
|---|---|
| Age, Continuous | 58.8 years STANDARD_DEVIATION 14.95 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 8 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 665 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 6 Participants |
| Race (NIH/OMB) Black or African American | 167 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 29 Participants |
| Race (NIH/OMB) White | 471 Participants |
| Region of Enrollment Belgium | 253 participants |
| Region of Enrollment United States | 420 participants |
| Sex: Female, Male Female | 304 Participants |
| Sex: Female, Male Male | 369 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 673 |
| other Total, other adverse events | 5 / 673 |
| serious Total, serious adverse events | 0 / 673 |
Outcome results
Primary
Number of Subjects With a Cardiopulmonary Event
The number of any cardiopulmonary event, not limited to: Cardiac arrest Sustained ventricular tachycardia (VT) Hypotension requiring inotropes or intra-aortic balloon pump (IABP) insertion Intubation or mechanical ventilation Complete heart block Bradycardia requiring insertion of a pacing wire or external pacing, and Percutaneous coronary intervention (PCI) or coronary artery bypass surgery (CABG)
Time frame: Within 72 hours of presentation to ED
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Enrolled | Number of Subjects With a Cardiopulmonary Event | 145 Participants |
Secondary
Cumulative Number of Cardiopulmonary Events in a Single Subject
The cumulative number of any cardiac and cardiac-related events, not limited to: In-hospital Death In-hospital Cardiac Arrest Composite cardiovascular outcome or intervention (Lethal Arrhythmias , Acute Pulmonary Edema, Cardiogenic Shock, Myocardial Infarction, Percutaneous Coronary Intervention, Coronary artery Bypass Surgery , New or Recurrent MI, Recurrent Ischemia requiring Revascularization)
Time frame: Within 72 hours of presentation to ED