Optical Detection of Intravenous Infiltration

NCT01126710 | Completed

• 2 other identifiers: IV-2010-015R44HL062008-06
• Study Type: observational
• Target: 263
• Locations: 1 country
• Sites: 1

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.

Conditions

Intravenous Infiltration; Extravasation of Diagnostic and Therapeutic Materials

Keywords

infiltration; extravasation; optical monitoring

Outcome Measures

Primary Outcomes (1)

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

  2 years

Eligibility Criteria

• Age: 3 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• Inability to consent
• Lack of a peripheral IV

Sponsors & Collaborators

• CW Optics, Inc.: lead
• National Institutes of Health (NIH): collaborator
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (1)

Virginia Commonwealth University Health System

Richmond, Virginia, 23298, United States

Location

MeSH Terms

Conditions

Extravasation of Diagnostic and Therapeutic Materials

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Wounds and Injuries

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Scientific Officer, CW Optics, Inc.

Study Record Dates

• First Submitted: May 18, 2010
• First Posted: May 20, 2010
• Study Start: May 1, 2010
• Last Updated: February 13, 2012

Record last verified: 2012-02

Locations

US (1)