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Monitoring the Peripheral Intravenous Infusion Site for Infiltration and Extravasation

NCT ID: NCT01476293

Last Updated: 2012-02-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

139 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-08-31

Study Completion Date

2012-02-29

Brief Summary

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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.

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Detailed Description

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Conditions

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

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

RETROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* signed consent
* patient age under 12
* PIV with continuous fluids

Exclusion Criteria

* no consent
* patient age over 12
* PIV fluids not continuous
Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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ivWatch, LLC

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Darcy Doellman, RN

Role: PRINCIPAL_INVESTIGATOR

Children's Hospital Medical Center, Cincinnati

Sylvia Rineair, MSHA, BSN

Role: PRINCIPAL_INVESTIGATOR

Children's Hospital Medical Center, Cincinnati

Neil Johnson, MD

Role: PRINCIPAL_INVESTIGATOR

Children's Hospital Medical Center, Cincinnati

Michael Spigarelli, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Children's Hospital Medical Center, Cincinnati

Locations

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Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, United States

Site Status

Countries

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United States

Other Identifiers

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ivWatch-CT-001

Identifier Type: -

Identifier Source: org_study_id

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