Optical Detection Infiltration/Extravasation in Neonates (ODINE)

Infant, Premature, Diseases Clinical Trial

— ODINE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05638971
• Other study ID #: 3886
• Status: Completed
• Phase: N/A
• Start date: August 1, 2021
• Est. completion date: July 12, 2022

Study information

• Verified date: November 2022
• Source: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: July 12, 2022
• Est. primary completion date: May 5, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 0 Days to 28 Days

Eligibility

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.

Related Conditions & MeSH terms

• Extravasation Injury
• Infant, Premature, Diseases

Intervention

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

Locations

Country	Name	City	State
Italy	FPGemelliIRCCS	Rome

Sponsors (1)

Lead Sponsor	Collaborator
Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Country where clinical trial is conducted

Italy, 

References & Publications (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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	TIME 2	time to detection (nurse vs ivWatch) and notification rate of the ivWatch	through study completion, an average of 30 hours