Verification of Prediction Algorithm

NCT02863666 | Completed Results

• 1 other identifier: 5703
• Study Type: observational
• Target: 673
• Locations: 2 countries
• Sites: 3

Brief Summary

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

Conditions

Shortness of Breath Episode; Tachycardia; Bradycardia; Difficulty Breathing

Keywords

Cariopulmonary, cardiac arrest

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Cumulative Number of Cardiopulmonary Events in a Single Subject

  Within 72 hours of presentation to ED

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Subjects presenting to the emergency department with cardiopulmonary related complaints

You may qualify if:

• 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.

You may not qualify if:

• Pregnant or suspected pregnancy Significant trauma Do Not Resuscitate order Known as Ward of the State

Sponsors & Collaborators

• Zoll Medical Corporation: lead

Study Sites (3)

University of Alabama

Birmingham, Alabama, 35249-7013, United States

Location

William Beaumont Hospital

Royal Oak, Michigan, 48073, United States

Location

Antwerp University Hospital

Antwerp, Belgium

Location

MeSH Terms

Conditions

Tachycardia; Bradycardia; Dyspnea; Heart Arrest

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Cardiac Conduction System Disease; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Respiration Disorders; Respiratory Tract Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms

Results Point of Contact

• Title: Brooke Lerner PHD,
• Organization: University of Buffalo

lerner@buffalo.edu

716.390.3509

Study Officials

• Michael Kurz, MD

  University of Alabama at Birmingham

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 8, 2016
• First Posted: August 11, 2016
• Study Start: August 11, 2016
• Primary Completion: December 13, 2017
• Study Completion: December 15, 2017
• Last Updated: May 13, 2024
• Results First Posted: May 13, 2024

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (2); BE (1)