Optical Detection of Intravenous Infiltration

NCT ID: NCT01126710

Last Updated: 2012-02-13

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

263 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-05-31

Brief Summary

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The purpose of this study is to investigate the safety and efficacy of an optical device designed and developed for monitoring the intravenous infusion site for infiltration. The hypothesis is that the changes in optical signals measured near the infusion site using the optical device can be used to monitor intravenous infusion for infiltration.

Detailed Description

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Conditions

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Intravenous Infiltration 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

* Subjects will have peripheral IV catheter with active infusions that are anticipated to be in place and functioning for 48-72 hours. The IVs and accompanying infusions are solely a part of the subject's medical care and are not started or terminated for the purposes of this Study. The rationale for choosing this time frame is that the rate of infiltration is likely to be increased the longer the IV infusion is taking place.
* Subjects are admitted to one of the institution's intensive care or intermediate care units, including Adult Emergency Department, Pediatric Emergency Department, Adult Medical Intensive Care Unit, Pediatric Intensive Care Unit, Neonatal Intensive Care Unity, Surgical-Trauma Intensive Care Unit, Cardiothoracic Surgery Intensive Care Unit, Neuroscience Intensive Care Unit, Burn Intensive Care Unit, Transplant Intensive Care Unit, Coronary Care Intensive Care Unit, Post-Anesthesia Recovery Unit, Pediatric Intermediate Care Unity, Surgical Intermediate Care Unit, and Medical Intermediate Care Unit.

Exclusion Criteria

* Inability to consent
* Lack of a peripheral IV
Minimum Eligible Age

3 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institutes of Health (NIH)

NIH

Sponsor Role collaborator

National Heart, Lung, and Blood Institute (NHLBI)

NIH

Sponsor Role collaborator

CW Optics, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Leonard Winchester, Ph.D.

Chief Scientific Officer, CW Optics, Inc.

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Virginia Commonwealth University Health System

Richmond, Virginia, United States

Site Status

Countries

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United States

Other Identifiers

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5R44HL062008-06

Identifier Type: NIH

Identifier Source: secondary_id

View Link

IV-2010-01

Identifier Type: -

Identifier Source: org_study_id

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