Verification of Prediction Algorithm (VPAC)

Verification of a Prediction Algorithm for Cardiopulmonary Patients Admitted to the Emergency Department (ED) (VPAC)

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

Study Overview

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

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 Type: Observational
• Enrollment (Actual): 673

Contacts and Locations

Study Locations

• Belgium
  • Antwerp, Belgium
    • Antwerp University Hospital
• United States
  • Alabama
    • Birmingham, Alabama, United States, 35249-7013
      • University of Alabama
  • Michigan
    • Royal Oak, Michigan, United States, 48073
      • William Beaumont Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Subjects presenting to the emergency department with cardiopulmonary related complaints

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	Within 72 hours of presentation to ED

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	Within 72 hours of presentation to ED

Collaborators and Investigators

• Sponsor: Zoll Medical Corporation
• Investigators: Principal Investigator: Michael Kurz, MD, University of Alabama at Birmingham

Study record dates

Study Major Dates

• Study Start (Actual): August 11, 2016
• Primary Completion (Actual): December 13, 2017
• Study Completion (Actual): December 15, 2017

Study Registration Dates

• First Submitted: August 8, 2016
• First Submitted That Met QC Criteria: August 8, 2016
• First Posted (Estimated): August 11, 2016

Study Record Updates

• Last Update Posted (Actual): May 13, 2024
• Last Update Submitted That Met QC Criteria: December 4, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: Cariopulmonary, cardiac arrest
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Respiratory Tract Diseases; Respiration Disorders; Signs and Symptoms, Respiratory; Arrhythmias, Cardiac; Cardiac Conduction System Disease; Bradycardia; Tachycardia; Dyspnea
• Other Study ID Numbers: 5703

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO