Monitoring the Peripheral Intravenous Infusion Site for Infiltration and Extravasation

NCT01476293 | Completed DMC

• 1 other identifier: ivWatch-CT-001
• Study Type: observational
• Target: 139
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

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

  6 months

Eligibility Criteria

• Age: Up to 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Subjects will be recruited from Cincinnati Children's Hospital Medical Center.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• ivWatch, LLC: lead

Study Sites (1)

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229, 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 Officials

• Darcy Doellman, RN

  Children's Hospital Medical Center, Cincinnati

  PRINCIPAL INVESTIGATOR

• Sylvia Rineair, MSHA, BSN

  Children's Hospital Medical Center, Cincinnati

  PRINCIPAL INVESTIGATOR

• Neil Johnson, MD

  Children's Hospital Medical Center, Cincinnati

  PRINCIPAL INVESTIGATOR

• Michael Spigarelli, MD, PhD

  Children's Hospital Medical Center, Cincinnati

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 9, 2011
• First Posted: November 22, 2011
• Study Start: August 1, 2011
• Primary Completion: February 1, 2012
• Study Completion: February 1, 2012
• Last Updated: February 20, 2012

Record last verified: 2011-11

Locations

US (1)