Verification of Prediction Algorithm

Completed

• Conditions: Shortness of Breath Episode; Tachycardia; Bradycardia; Difficulty Breathing

• Registration Number: NCT02863666
• Lead Sponsor: Zoll Medical Corporation

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.

Study Timeline

• Study First Submitted: 2016-08-08
• Study First Submitted QC: 2016-08-08
• Study Start: 2016-08-11
• Study First Posted: 2016-08-11
• Primary Completion: 2017-12-13
• Study Completion: 2017-12-15
• Results First Submitted: 2021-10-19
• Status Verified: 2023-12
• Results First Submitted QC: 2023-12-04
• Last Update Submitted: 2023-12-04
• Results First Posted: 2024-05-13
• Last Update Posted: 2024-05-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 673

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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)

Trial Locations

Locations (3)

William Beaumont Hospital; 🇺🇸 Royal Oak, Michigan, United States

University of Alabama; 🇺🇸 Birmingham, Alabama, United States

Antwerp University Hospital; 🇧🇪 Antwerp, Belgium