Monitoring the Peripheral Intravenous Infusion Site for Infiltration and Extravasation

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01476293

Enrollment

139

Registered

2011-11-22

Start date

2011-08-31

Completion date

2012-02-29

Last updated

2012-02-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

Infiltration, Extravasation, Leaking, PIV Infiltration, IV Infiltration, Optical Detection of Infiltration, Optical Monitoring

Brief 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.

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

No minimum to 12 Years

Healthy volunteers

Inclusion criteria

* signed consent * patient age under 12 * PIV with continuous fluids

Exclusion criteria

* no consent * patient age over 12 * PIV fluids not continuous

Design outcomes

Primary

Measure	Time frame
Test performance of optical device for monitoring intravenous infusion site for infiltration.	6 months

Countries

United States

Outcome results