Optical Detection Infiltration/Extravasation in Neonates (ODINE)

Institute of Hospitalization and Scientific Care (IRCCS)

Status: Completed

Conditions: Infant, Premature, Diseases; Extravasation Injury

Treatments: Device: ivWatch

Study type: Interventional

Funder types: Other

Identifiers

NCT05638971

3886

Details and patient eligibility

About

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.

Enrollment: 50 patients

Sex: All

Ages: Under 28 days old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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50 participants in 1 patient group

Sensor Group

Experimental group

Description:

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

Treatment:

Device: ivWatch