Monitoring the Peripheral Intravenous Infusion Site for Infiltration and Extravasation

Infiltration Clinical Trial

Official title:

Non-invasive Optical Medical Device for Monitoring and Detecting Peripheral Intravenous Infusion Sites for Infiltration and Extravasation in Subjects Receiving Continuous Fluids

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01476293
• Other study ID #: ivWatch-CT-001
• Status: Completed
• Phase: N/A
• First received: November 9, 2011
• Last updated: February 17, 2012
• Start date: August 2011
• Est. completion date: February 2012

Study information

• Verified date: November 2011
• Source: ivWatch, LLC
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

The purpose of this study to to monitor the peripheral intravenous (PIV) site on subjects receiving continuous IV fluids for infiltration and extravasation events. Infiltration is an indication that the PIV is leaking fluids outside of the vascular system. The study hypothesis is to demonstrate that changes in the optical signals of the non-invasive monitoring medical device will detect infiltration and extravasation events.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 139
• Est. completion date: February 2012
• Est. primary completion date: February 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 12 Years

Eligibility

Inclusion Criteria:

• signed consent

• patient age under 12

• PIV with continuous fluids

Exclusion Criteria:

• no consent

• patient age over 12

• PIV fluids not continuous

Study Design

Observational Model: Case-Only, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Extravasation
• Extravasation of Diagnostic and Therapeutic Materials
• Infiltration
• IV Extravasation
• IV Infiltration

Locations

Country	Name	City	State
United States	Cincinnati Children's Hospital Medical Center	Cincinnati	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
ivWatch, LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Test performance of optical device for monitoring intravenous infusion site for infiltration.		6 months	Yes