Skip to main content
OpenTrials
Completed

NCT Number: NCT01126710

Optical Detection of Intravenous Infiltration

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Intravenous Infiltration Extravasation of Diagnostic and Therapeutic Materials Pathologic Processes Pathological Conditions, Signs and Symptoms Wounds and Injuries

Age range

3 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Virginia Commonwealth University Health System

Richmond, Virginia, 23298, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Test performance of novel optical device for monitoring intravenous infusion site for infiltration.

    Time frame: 2 years

Sponsors and collaborators

Lead sponsor

CW Optics, Inc.

Industry

Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)
  • National Institutes of Health (NIH)

Registry information

Important dates

Study start
2010
First posted
May 20, 2010
Registry last updated
Feb 13, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.