Optical Detection Infiltration/Extravasation in Neonates (ODINE) (ODINE)

Optical Detection Infiltration/Extravasation in Neonates, a Continuous Monitoring for Peripheral Venous Accesses.

Peripheral intravenous (PIV) therapy is one of the most common invasive procedures performed in hospitals. PIV failures often occur when fluids leak out of the vein into surrounding tissue. This failure is usually called infiltration if the leakage involves non-vesicant solutions or extravasation in case of vesicant solutions. In this clinical study both infiltration and extravasation events are indicated by the term "infiltration".

neonatal intensive care unit patients are an high-risk population for infiltration due to their intrinsic characteristic: poor and fragile vein asset, frequent and uncontrolled movements, need for prolonged intravenous drug and fluid administration. Current nursing practice involves regular PIV site assessments for continuous infusions; particular attention is payed to the identification of swelling, pain, redness, warmth, or coolness. As infiltration represents a leading cause of iatrogenic injury, an early identification, an early identification can minimize its consequences.

The ivWatch Model 400 is a device that assists medical professionals in monitoring patients for PIV infiltrations using an optical sensor. This device received FDA clearance and European Conformity Mark for use in the adult and pediatric age groups. ivWatch enhanced the Model 400 to support a new disposable electronic sensor (SmartTouch sensor). In this study, the SmartTouch Sensor will be tested in a neonatal population in a NICU setting. The new sensor design includes optical components in the sensor package, similar to a typical pulse oximeter.

Primary study objective is to investigate whether the ivWatch SmartTouch sensor may be helpful in early identification of any kind of infiltration, if compared with our current standards of care.

Study Overview

• Status: Completed
• Conditions: Extravasation Injury; Infant, Premature, Diseases
• Intervention / Treatment: Device: ivWatch

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Rome, Italy, 00168
    • FPGemelliIRCCS

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 second to 4 weeks (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Term and pre-term infants;
• birth weight > 1.5 kg;
• need for continuous IV therapy with an expected duration > 24 hours.

Exclusion Criteria:

• birth weight </= 1.5 kg;
• non continuous IV therapy;
• IV therapy expected duration </= 24 hours;
• skin disorders.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Sensor Group; The first half sample size Peripheral intravenous canula will be enrolled in a non-alarming group. ivWatch will monitor the Peripheral intravenous canula insertion site collecting data without notifications. The goals of the study on the nonalarming group are: a) to evaluate ivWatch sensitivity to detect infiltration in comparison with nurse standard of care; b) to estimate the difference in terms of time to detection of ivWatch in comparison with nurse standard of care

Device: ivWatch; The second half sample size PIVC will be enrolled into an alarming group. ivWatch will monitor the PIVC insertion site collecting data and sending visual and auditory notifications of any infiltration. The goals of the study on the alarming group are: a) to estimate the notification rate (the number of detected infiltration in the studied period; b) to evaluate the extension and severity of the detected infiltration at the time of the notification, so to gather if ivWatch is helpful in early diagnosis; Other Names: Sensor Allarm Group

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
TIME	How many times the ivWatch detect infiltrations before nurses. The degree of injury is calculated on the Millian scale.	through study completion, an average of 30 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
TIME 2	time to detection (nurse vs ivWatch) and notification rate of the ivWatch	through study completion, an average of 30 hours

Collaborators and Investigators

• Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Publications and helpful links

General Publications

• Wallis MC, McGrail M, Webster J, Marsh N, Gowardman J, Playford EG, Rickard CM. Risk factors for peripheral intravenous catheter failure: a multivariate analysis of data from a randomized controlled trial. Infect Control Hosp Epidemiol. 2014 Jan;35(1):63-8. doi: 10.1086/674398. Epub 2013 Dec 2.
• Helm RE, Klausner JD, Klemperer JD, Flint LM, Huang E. Accepted but Unacceptable: Peripheral IV Catheter Failure. J Infus Nurs. 2019 May/Jun;42(3):151-164. doi: 10.1097/NAN.0000000000000326.

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2021
• Primary Completion (Actual): May 5, 2022
• Study Completion (Actual): July 12, 2022

Study Registration Dates

• First Submitted: November 16, 2022
• First Submitted That Met QC Criteria: November 24, 2022
• First Posted (Estimate): December 6, 2022

Study Record Updates

• Last Update Posted (Estimate): December 6, 2022
• Last Update Submitted That Met QC Criteria: November 24, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infant, Newborn, Diseases; Infant, Premature, Diseases
• Other Study ID Numbers: 3886

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No