Optical Detection Infiltration/Extravasation in Neonates (ODINE)

Not Applicable

Completed

• Conditions: Extravasation Injury; Infant, Premature, Diseases
• Interventions: Device: ivWatch

• Registration Number: NCT05638971
• Lead Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-08-01
• Primary Completion: 2022-05-05
• Study Completion: 2022-07-12
• Status Verified: 2022-11
• Study First Submitted: 2022-11-16
• Study First Submitted QC: 2022-11-24
• Last Update Submitted: 2022-11-24
• Study First Posted: 2022-12-06
• Last Update Posted: 2022-12-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Sensor Group	ivWatch	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

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

FPGemelliIRCCS; 🇮🇹 Rome, Italy