Optical Detection of Intravenous Infiltration

Completed

• Conditions: Intravenous Infiltration; Extravasation of Diagnostic and Therapeutic Materials

• Registration Number: NCT01126710
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-05
• Study First Submitted: 2010-05-18
• Study First Submitted QC: 2010-05-18
• Study First Posted: 2010-05-20
• Status Verified: 2012-02
• Last Update Submitted: 2012-02-09
• Last Update Posted: 2012-02-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 263

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Test performance of novel optical device for monitoring intravenous infusion site for infiltration.	2 years

Trial Locations

Locations (1)

Virginia Commonwealth University Health System; 🇺🇸 Richmond, Virginia, United States