Verification of Prediction Algorithm

Zoll Medical Corporation673 enrolled

Overview

Prospective observational clinical study to verify an algorithm used to predict cardiopulmonary events in patients presenting to the emergency department.

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.

Study Type

OBSERVATIONAL

Enrollment

673

Conditions

Shortness of Breath Episode Tachycardia Bradycardia Difficulty Breathing

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (3)

University of Alabama

Birmingham, Alabama, United States

William Beaumont Hospital

Royal Oak, Michigan, United States

Antwerp University Hospital

Antwerp, Belgium

Outcomes

Primary Outcomes

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

Secondary Outcomes

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

Data from ClinicalTrials.gov

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