Comparing Ultrasound Guided PICC Line Insertion in Neonates With Standard Procedure
Condition: Ultrasonography, Interventional; Peripheral Venous Catheterization
Study type: Interventional

Summary: 
      This is a randomized controlled study comparing US guided vs standard procedure for PICC line
      placement in newborns admitted to Children's Hospital of Eastern Ontario Neonatal Intensive
      Care Unit who require a PICC line. Patients will be randomized using REDCap randomization
      module (stratified by gestational age < 28 weeks and >= 28 weeks and blocked to ensure
      approximate balance with each stratum) into two arms. - Arm 1: PICC line insertion procedure
      using anatomical landmarks and tip placement will be confirmed by X-ray (current standard);
      Arm 2: US guided PICC line insertion procedure and tip placement confirmation by both US and
      X-ray. Sample size of 33 infants per group would achieve greater than 80% power to detect a
      difference between groups.

      Primary outcome: Time to complete the standard versus the US-guided procedure.

      Secondary outcomes (comparison between two arms):

      The number of total "venipuncture" attempts needed to place a PICC line Number of tip
      manipulations after complete insertion Proportion of successful tip placement
    

Detailed description: 
      Background Peripherally Inserted Central Catheter (PICC) line placement is one of the most
      commonly performed procedures in Neonatology. Due to prematurity and small vein size, the
      procedure often requires multiple attempts over an increased timeframe. As a standard of
      care, the position is confirmed by X-ray. Frequently, catheters are not optimally positioned,
      necessitating repositioning and further radiographs.

      The use of ultrasound (US) guidance for PICC line placement enhances the visualization of the
      veins and provides a better selection for optimal access. It could decrease or even eliminate
      the need for X-rays when used to confirm the tip position.

      Objectives To demonstrate that using US-guidance to place and confirm tip positioning for
      PICC line insertion in neonates will decrease the number of cannulation attempts, will
      shorten the time needed to complete the procedure, and will decrease infants' exposure to
      radiation.

      Methods This is a randomized controlled study comparing US guided vs standard procedure for
      PICC line placement in newborns admitted to CHEO NICU who require a PICC line (approximately
      130-150 infants per year). Patients will be randomized using REDCap randomization module
      (stratified by gestational age < 28 weeks and >= 28 weeks and blocked to ensure approximate
      balance with each stratum) into two arms - Arm 1: PICC line insertion procedure using
      anatomical landmarks and tip placement will be confirmed by X-ray (current standard); Arm 2:
      US guided PICC line insertion procedure and tip placement confirmation by both US and X-ray.
      A sample size of 33 infants per group would be sufficient to achieve greater than 80% power
      to detect a difference between groups.

      Results of this study may demonstrate that US guided PICC line placement is superior (shorter
      and safer procedure, reduced radiation and pain) to currently used procedure and could lead
      to practice change.
    

Intervention name(s): Ultrasound guidance for PICC line placement
Intervention type(s): Procedure
Intervention description(s): Apply ultrasound guidance for PICC line placement and positioning in newborns
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: ultrasound; PICC line; neonate