Optical Detection of Intravenous Infiltration | NCT01126710

Studies
Optical Detection of Intravenous Infiltration

NCT01126710

Sponsor

CW Optics, Inc.

Status

Completed

Last Update Posted

Feb 13, 2012Estimated

Enrollment

263Actual

Phase

Not provided

Conditions

Intravenous Infiltration
Extravasation of Diagnostic and Therapeutic Materials

Interventions

Not provided

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
5R44HL062008-06	U.S. NIH Grant/Contract		View source

Status Module

Record Verification Date

Feb 2012

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2010

Primary Completion Date

Not provided

Completion Date

Not provided

First Submitted Date

May 18, 2010

First Submission Date that Met QC Criteria

May 18, 2010

First Posted Date

May 20, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 9, 2012

Last Update Posted Date

Feb 13, 2012Estimated

Name	Class
National Institutes of Health (NIH)	NIH
National Heart, Lung, and Blood Institute (NHLBI)	NIH

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

263Actual

Measure	Description	Time Frame
Test performance of novel optical device for monitoring intravenous infusion site for infiltration.		2 years

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

3 Years

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Subjects recruited from the patient population at Virginia Commonwealth University Health System will be enrolled in the Study.

Sampling Method

Non-Probability Sample

Facility	Status	City	State	ZIP	Country	Contacts
Virginia Commonwealth University Health System		Richmond	Virginia	23298	United States

Condition Browse Module

MeSH Terms

ID	Term
D005119	Extravasation of Diagnostic and Therapeutic Materials

Ancestor Terms

ID	Term
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms
D014947	Wounds and Injuries

Browse Leaves

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Browse Branches

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