NCT02466633

Brief Summary

To increase the potential for timely detection and treatment of cardiac events, hospitals have implemented a number of different cardio-respiratory monitoring methods for at-risk patients. The goal of this study is to compare different monitoring methods to determine the most efficient method to monitor hospitalized patients - the method that will lead to the quickest response to critical heart rhythms. The investigators will then test the efficiency of this monitoring method by implementing it in a new patient care unit.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
250

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2015

Longer than P75 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 3, 2015

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 9, 2015

Completed
3 months until next milestone

Study Start

First participant enrolled

September 1, 2015

Completed
4.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 26, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 26, 2020

Completed
Last Updated

June 1, 2021

Status Verified

May 1, 2021

Enrollment Period

4.5 years

First QC Date

June 3, 2015

Last Update Submit

May 27, 2021

Conditions

Arrhythmias, Cardiac

Outcome Measures

Primary Outcomes (1)

  • Response time to a simulated (not real) critical cardiac arrhythmia (pulseless ventricular tachycardia or ventricular fibrillation)

    After critical arrhythmia is simulated (approximately 1-5 minutes)

Study Arms (1)

Change in in-hospital cardiac monitoring method

EXPERIMENTAL

Pre- and post-intervention, where the intervention is a change in in-hospital cardiac monitoring method

Other: In-hospital cardiac monitoring method

Interventions

In-hospital cardiac monitoring methodOTHER

Method for monitoring hospitalized patients at risk for cardiac arrhythmias (non-ICU)

Change in in-hospital cardiac monitoring method

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Care providers including the individuals responsible for monitoring patients (monitoring technicians and nurses), individuals communicating life threatening events (monitoring technicians, health unit coordinators, and nurses) and the individuals responsible for the initial check on a patient in the event of life-threatening cardiac arrhythmias (generally the patient's nurse).
  • Patients for whom cardiac monitoring was ordered by their physician.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Arrhythmias, Cardiac

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Noa Segall, PhD

    Duke University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 3, 2015

First Posted

June 9, 2015

Study Start

September 1, 2015

Primary Completion

February 26, 2020

Study Completion

February 26, 2020

Last Updated

June 1, 2021

Record last verified: 2021-05