Optical Detection of Intravenous Infiltration:A Pilot Study

Infiltration of Peripheral IV Therapy Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02553421
• Other study ID #: IVW-CLR-CS09-400
• Status: Completed
• Phase: N/A
• First received: September 16, 2015
• Last updated: July 25, 2016
• Start date: August 2015
• Est. completion date: July 2016

Study information

• Verified date: July 2016
• Source: ivWatch, LLC
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

This study will examine the use of the ivWatch Model 400 to monitor PIV sites in pediatric patients. Half the participants will be monitored by the device without infiltration notifications and the other half will be monitored by the device with infiltration notifications enabled.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 243
• Est. completion date: July 2016
• Est. primary completion date: July 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 17 Years

Eligibility

Inclusion Criteria:

• Signed consent and/or assent

• Newborn to 17 years of age

• Weight > 2.5 kg

Exclusion Criteria:

• Severe skin integrity issues such as severe eczema, burns, epidermolysis bullosa, rash, hives

• Severe scarring of tissue (excessive IV use)

• Tattoo in area of PIV site

• IV site located in antecubital fossa

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Infiltration of Peripheral IV Therapy

Intervention

Device:
• ivWatch Model 400
The ivWatch Model 400 is placed next to the subject's PIV site. All subjects will receive standard care for their IV sites including the normal routine assessments of the IV site by the bedside registered nurses.

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	Time infiltration detected by nurse		Participants will be followed for the duration of intravenous therapy, an expected duration of up to 1 week	No
Primary	Time infiltration detected by ivWatch device		Participants will be followed for the duration of intravenous therapy, an expected duration of up to 1 week	No
Primary	Notification rate of ivWatch device		Participants will be followed for the duration of intravenous therapy, an expected duration of up to 1 week	No