N/A
Completed N=243
Optical Detection of Intravenous Infiltration:A Pilot Study
Infiltration of Peripheral IV Therapy
Source: ClinicalTrials.gov NCT02553421 ↗
Enrolled (actual)
243
Serious AEs
0.0%
Results posted
Jan 2017
Primary outcomePrimary: Time Infiltration Detected by Nurse — 29.8; 32.3 hours
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Time Infiltration Detected by Nurse |
29.8; 32.3 | — |
| PRIMARY Infiltration Sensitivity |
78.3; 80 | — |
| PRIMARY Notification Rate of ivWatch Device |
0.280; 0.274 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT02553421). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.