Monitoring the Peripheral Intravenous Infusion Site for I... | NCT01476293

Studies
Monitoring the Peripheral Intravenous Infusion Site for Infiltration and Extravasation

NCT01476293

Sponsor

ivWatch, LLC

Status

Completed

Last Update Posted

Feb 20, 2012Estimated

Enrollment

139Actual

Phase

Not provided

Conditions

Infiltration
Extravasation
IV Infiltration
IV Extravasation
Extravasation of Diagnostic and Therapeutic Materials

Interventions

Not provided

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

Nov 2011

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

Aug 2011

Primary Completion Date

Feb 2012Actual

Completion Date

Feb 2012Actual

First Submitted Date

Nov 9, 2011

First Submission Date that Met QC Criteria

Nov 17, 2011

First Posted Date

Nov 22, 2011Estimated

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

Feb 17, 2012

Last Update Posted Date

Feb 20, 2012Estimated

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 to to monitor the peripheral intravenous (PIV) site on subjects receiving continuous IV fluids for infiltration and extravasation events. Infiltration is an indication that the PIV is leaking fluids outside of the vascular system. The study hypothesis is to demonstrate that changes in the optical signals of the non-invasive monitoring medical device will detect infiltration and extravasation events.

Detailed Description

Not provided

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

139Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Test performance of optical device for monitoring intravenous infusion site for infiltration.		6 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

signed consent
patient age under 12
PIV with continuous fluids

Exclusion Criteria:

no consent
patient age over 12
PIV fluids not continuous

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

12 Years

Standard Ages

Child

Study Population

Subjects will be recruited from Cincinnati Children's Hospital Medical Center.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Darcy Doellman, RN	Children's Hospital Medical Center, Cincinnati	Principal Investigator
Sylvia Rineair, MSHA, BSN	Children's Hospital Medical Center, Cincinnati	Principal Investigator
Neil Johnson, MD	Children's Hospital Medical Center, Cincinnati	Principal Investigator
Michael Spigarelli, MD, PhD	Children's Hospital Medical Center, Cincinnati	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Cincinnati Children's Hospital Medical Center		Cincinnati	Ohio	45229	United States

Condition Browse Module

MeSH Terms

ID	Term
D005119	Extravasation of Diagnostic and Therapeutic Materials

Ancestor Terms

ID	Term
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms
D014947	Wounds and Injuries

Browse Leaves

Not provided

Browse Branches

Not provided