NCT02918604

Pediatric Veins Cannulation Technique

Peripheral Veins Cannulation in Children Using Veinsite: a Randomized Clinical Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 80 (actual)
• Sponsor: Bambino Gesù Hospital and Research Institute · Academic / Other
• Sex: All
• Age: 4 Years
• Healthy volunteers: Not accepted

Summary

multicenter, prospective and cohort study to evaluate infrared technology for identifying and and indwelling peripheral veins in 0 up to 4 years old children.

Detailed description

AIM OF THE STUDY The primary objective of this study is to determine the success rate at first attempt of peripheral veins cannulation in small children (\<5yrs) and infants (\<1yr) of Veinsite compared with traditional palpation method performed by skilled operators. The secondary objective of this study is to determine the time to cannulation using the two techniques, the difference in visualized veins using the Veinsite or the direct visualization and palpation of the patients' skin, cannula indwelling time and complications related to the procedure. DESIGN Prospective randomized controlled study Population It is expected to recruit 60 pediatric patients undergoing peripheral vein cannulation with known difficulties according the difficult venous access score (DIVA) (6) in the following centers: 1. Fondazione IRCCS Istituto Neurologico "C.Besta" , Milano 2. Ospedale Pediatrico Bambino Gesù, IRCCS, Roma Duration of study Patient will be followed from the day of peripheral vein cannulation till the peripheral cannula will be removed (max 3 days) in order to assess any cause of venous extravasation. The recruitment phase is supposed to be 6 months after achieving the ethical-administrative authorization.

Conditions

• Successful Vein Cannulation at First Attempt

Interventions

Type	Name	Description
DEVICE	infrared technology: Veinsite	peripheral vein access performed with Veinsite support by expert paediatric anaesthesiologists and intensivists

Timeline

• Start date: 2015-01-01
• Primary completion: 2016-01-01
• Completion: 2016-05-01
• First posted: 2016-09-29
• Last updated: 2016-09-29