Validation of the NTX Wireless Patient Monitoring System | NCT00644644

Studies
Validation of the NTX Wireless Patient Monitoring System

NCT00644644

Sponsor

Vanderbilt University Medical Center

Status

Completed

Last Update Posted

Apr 11, 2017Actual

Enrollment

1,303Actual

Phase

Not provided

Conditions

Desaturation
Bradycardia
Tachycardia
Hypertension
Hypotension

Interventions

Rapid Response Team (NTX wireless monitoring 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

Apr 2017

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

Mar 2008

Primary Completion Date

Jan 2010Actual

Completion Date

Jan 2010Actual

First Submitted Date

Mar 19, 2008

First Submission Date that Met QC Criteria

Mar 25, 2008

First Posted Date

Mar 27, 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

Apr 7, 2017

Last Update Posted Date

Apr 11, 2017Actual

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

Reduction in time to detection of Clinically Significant events
Reduction of time to Intervention during Clinically Significant events
Reduction in the number of admissions to Intensive Care

Detailed Description

1200 patients will have wireless monitors attached to their arm. They will be randomized to have their vital signs filtered through software that generates alerts, or software that does not generate alerts. Low and high limit alarms will be set according to published guidelines and adjusted at will by the response team. If appropriate the Vanderbilt University Medical Center Rapid Response team will be initiated per Institutional Policy

Design Module

Study Type

Observational

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 provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

1,303Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1		monitored	Other: Rapid Response Team (NTX wireless monitoring system)
2		control

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Rapid Response Team (NTX wireless monitoring system)	Other	If the subject is experiencing a life threatening change in their vital signs, the Rapid Response Team will be initiated per VUMC protocol.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
To determine if the NTX wireless monitoring system in combination with a novel computer interface will provide early detection of potentially life threatening changes in patient's vital signs		an interim analysis will be performed after 400 patients have been placed on the study, again after 800 have been places on the study

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Ability to give written informed consent
Patients that are hospitalized for longer than 24 hours and are located on the 4th, 5th, or 6th floor of the Vanderbilt University Medical Center Round Wing
Patients must be ≥18 years of age

Exclusion Criteria:

ICU patients
Female subjects who are pregnant
Patients < 18 years of age
Patients that have a contradiction for continuous Blood Pressure monitoring

Accepts Healthy Volunteers

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

Post-op orthopedic and GI patients who will be admitted for a minimum of 24 hours to the Round Wing area of Vanderbilt University Medical Center.

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Daniel J France, PhD, MPH	Vanderbilt University Medical Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Vanderbilt University Medical Center		Nashville	Tennessee	37212	United States

References Module

Citations

Not provided

ID	Term
D001145	Arrhythmias, Cardiac
D006331	Heart Diseases
D002318	Cardiovascular Diseases
D010335	Pathologic Processes

ID	Term
D010348	Patient Care Team
D010346	Patient Care Management
D006298	Health Services Administration

ID	Term
D001919	Bradycardia
D013610	Tachycardia
D006973	Hypertension
D007022	Hypotension