Clinical trial NCT05638971: Optical Detection Infiltration/Extravasation in Neonates (ODINE)
Official title: Optical Detection Infiltration/Extravasation in Neonates, a Continuous Monitoring for Peripheral Venous Accesses.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Extravasation Injury
Infant, Premature, Diseases
Lead sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Sponsor class: OTHER
First posted: 2022-12-06
Enrollment: 50
Sex: ALL
Minimum age (years): 0
Maximum age (years): 28
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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.


Eligibility criteria: 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.

Primary outcomes:
measure: TIME
timeFrame: through study completion, an average of 30 hours
Secondary outcomes:
measure: TIME 2
timeFrame: through study completion, an average of 30 hours
Other outcomes:
Locations:
city: Rome
country: Italy
facility: FPGemelliIRCCS
Study officials:
References:
citation: 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.
citation: 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.