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Clinical Trials/NCT01126710
NCT01126710
Completed
Not Applicable

Optical Detection of Intravenous Infiltration

CW Optics, Inc.1 site in 1 country263 target enrollmentMay 2010

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Intravenous Infiltration
Sponsor
CW Optics, Inc.
Enrollment
263
Locations
1
Primary Endpoint
Test performance of novel optical device for monitoring intravenous infusion site for infiltration.
Status
Completed
Last Updated
14 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
May 2010
End Date
TBD
Last Updated
14 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Leonard Winchester, Ph.D.

Chief Scientific Officer, CW Optics, Inc.

CW Optics, Inc.

Eligibility Criteria

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

Outcomes

Primary Outcomes

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

Time Frame: 2 years

Study Sites (1)

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