PREVENT - Prospective Rhythm Event Surveillance in the ER... | NCT00750958

Studies
PREVENT - Prospective Rhythm Event Surveillance in the ER With NetGuard

NCT00750958

Sponsor

Datascope Patient Monitoring

Status

Completed

Last Update Posted

Sep 11, 2008Estimated

Enrollment

287Actual

Phase

Not Applicable

Conditions

Cardiac Event

Interventions

NetGuard Automated Clinician Alert System

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2008

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2008

Primary Completion Date

Jul 2008Actual

Completion Date

Jul 2008Actual

First Submitted Date

Sep 10, 2008

First Submission Date that Met QC Criteria

Sep 10, 2008

First Posted Date

Sep 11, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 10, 2008

Last Update Posted Date

Sep 11, 2008Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

287Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	No Intervention	ED patients that are not monitored with conventional therapy.	Procedure: NetGuard Automated Clinician Alert System

Interventions

Name	Type	Description	Arm Group Labels	Other Names
NetGuard Automated Clinician Alert System	Procedure	Monitoring System for in-hospital patients who are typically unmonitored. Identifies and alarms for cardiac rhythm changes.	1

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Incidence of clinically significant rhythm and rate changes in ED patients.		Patient ED stay

Secondary Outcomes

Measure	Description	Time Frame
Measure of user-friendliness of the device.		Patient ED stay

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Charles Pollack, MD	Pennslvania Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Dr Charles Pollack		Philadelphia	Pennsylvania	19107	United States
University of Pennsylvania

Condition Browse Module

MeSH Terms

ID	Term
D002318	Cardiovascular Diseases

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided