ClinicalTrials.gov
ClinicalTrials.gov Menu

Optical Detection of Intravenous Infiltration

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01126710
Recruitment Status : Completed
First Posted : May 20, 2010
Last Update Posted : February 13, 2012
Sponsor:
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.

Brief Summary:
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 or disease
Intravenous Infiltration Extravasation of Diagnostic and Therapeutic Materials

Study Type : Observational
Actual Enrollment : 263 participants
Observational Model: Case-Only
Time Perspective: Retrospective
Official Title: Optical Detection of Intravenous Infiltration
Study Start Date : May 2010



Primary Outcome Measures :
  1. Test performance of novel optical device for monitoring intravenous infusion site for infiltration. [ Time Frame: 2 years ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   3 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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)

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 ( U.S. NIH Grant/Contract )
First Posted: May 20, 2010    Key Record Dates
Last Update Posted: February 13, 2012
Last Verified: February 2012

Keywords provided by Leonard Winchester, Ph.D., CW Optics, Inc.:
infiltration
extravasation
optical monitoring

Additional relevant MeSH terms:
Extravasation of Diagnostic and Therapeutic Materials
Pathologic Processes
Wounds and Injuries