Optical Detection of Intravenous Infiltration

This study has been completed.

First Received on May 18, 2010. Last Updated on February 9, 2012 History of Changes

Sponsor:	CW Optics, Inc.
Collaborators:	National Institutes of Health (NIH) National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):	Leonard Winchester, Ph.D., CW Optics, Inc.
ClinicalTrials.gov Identifier:	NCT01126710

Purpose

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.

Condition
Intravenous Infiltration Extravasation of Diagnostic and Therapeutic Materials

Study Type:	Observational
Study Design:	Observational Model: Case-Only Time Perspective: Retrospective
Official Title:	Optical Detection of Intravenous Infiltration

Further study details as provided by CW Optics, Inc.:

Primary Outcome Measures:

Test performance of novel optical device for monitoring intravenous infusion site for infiltration. [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]

Enrollment:	263
Study Start Date:	May 2010

Eligibility

Ages Eligible for Study:	3 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

Subjects recruited from the patient population at Virginia Commonwealth University Health System will be enrolled in the Study.

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01126710

Locations

United States, Virginia
Virginia Commonwealth University Health System
Richmond, Virginia, United States, 23298

Sponsors and Collaborators

CW Optics, Inc.

National Institutes of Health (NIH)

National Heart, Lung, and Blood Institute (NHLBI)

More Information

No publications provided

Responsible Party:	Leonard Winchester, Ph.D., Chief Scientific Officer, CW Optics, Inc., CW Optics, Inc.
ClinicalTrials.gov Identifier:	NCT01126710 History of Changes
Other Study ID Numbers:	IV-2010-01, 5R44HL062008-06
Study First Received:	May 18, 2010
Last Updated:	February 9, 2012
Health Authority:	United States: Institutional Review Board

Keywords provided by CW Optics, Inc.:

infiltration
extravasation
optical monitoring

Additional relevant MeSH terms:

Extravasation of Diagnostic and Therapeutic Materials
Pathologic Processes
Wounds and Injuries

ClinicalTrials.gov processed this record on May 23, 2012