NCT00750958

Brief Summary

The purpose of this study is to determine the incidence of clinically significant rhythm and rate changes in ED patients who are not placed on conventional telemetry, and to test the user-friendliness of a automated clinician alter device in hectic and noisy setting of a busy emergency room.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
287

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2008

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2008

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2008

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

September 10, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 11, 2008

Completed
Last Updated

September 11, 2008

Status Verified

September 1, 2008

Enrollment Period

1 month

First QC Date

September 10, 2008

Last Update Submit

September 10, 2008

Conditions

Cardiac Event

Keywords

cardiac rhythm changes

Outcome Measures

Primary Outcomes (1)

  • Incidence of clinically significant rhythm and rate changes in ED patients.

    Patient ED stay

Secondary Outcomes (1)

  • Measure of user-friendliness of the device.

    Patient ED stay

Study Arms (1)

1

NO INTERVENTION

ED patients that are not monitored with conventional therapy.

Procedure: NetGuard Automated Clinician Alert System

Interventions

NetGuard Automated Clinician Alert SystemPROCEDURE

Monitoring System for in-hospital patients who are typically unmonitored. Identifies and alarms for cardiac rhythm changes.

Also known as: NetGurard Automated Clinican Alert Systemm
1

Eligibility Criteria

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

You may qualify if:

  • \> 18 yes
  • Agree to participate in study
  • Telemetry not indicated
  • Telemetry not available
  • Willingness to complete a questionnaire-

You may not qualify if:

  • Refusal to participate
  • Know sensitivity to adhesive
  • Language/communication barriers
  • Perceived high risk for lack of study compliance

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Dr Charles Pollack

Philadelphia, Pennsylvania, 19107, United States

Location

University of Pennsylvania

Philadelphia, Pennsylvania, 19107, United States

Location

MeSH Terms

Conditions

Cardiovascular Diseases

Study Officials

  • Charles Pollack, MD

    Pennslvania Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

September 10, 2008

First Posted

September 11, 2008

Study Start

June 1, 2008

Primary Completion

July 1, 2008

Study Completion

July 1, 2008

Last Updated

September 11, 2008

Record last verified: 2008-09

Locations

US(2)