Clinical trial NCT02584530: Comparing Ultrasound Guided PICC Line Insertion in Neonates With Standard Procedure
Official title: A Randomized Controlled Trial Comparing Ultrasound Guided PICC Line Insertion in Neonates With Standard Procedure
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ultrasonography, Interventional
Peripheral Venous Catheterization
Keywords: ultrasound
PICC line
neonate
Lead sponsor: Children's Hospital of Eastern Ontario
Sponsor class: OTHER
First posted: 2015-10-22
Enrollment: 60
Sex: ALL
Minimum age (years): 1
Maximum age (years): 28
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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.

Eligibility criteria: Inclusion Criteria:

All newborns (0-28 days) admitted to Neonatal Intensive Care Unit who require PICC line insertion after consent has been obtained to include in this study. Including:

* Infants who need prolonged Total Parenteral Nutrition requirement of \> 7 days.
* Infants with difficult peripheral venous access who requires a central line
* Infants who require IV medications for \> 7 days.
* Infants who require medications given by central IV access
* Infants who will undergo complex surgical procedures and will require central IV access before procedure.

Exclusion Criteria:

* Infants requiring isolation according to infection control protocols
* Unable to obtain or refused consent for PICC line and/or study enrolment
* Infants with any clinical contraindication for PICC line insertion as per unit policy

Primary outcomes:
measure: Time to complete the standard versus the US-guided procedure
timeFrame: one year
Secondary outcomes:
measure: Number of total venipuncture attempts needed to place a PICC line
timeFrame: One year
measure: Number of tip manipulations after complete insertion
timeFrame: One year
measure: Proportion of successful tip placement
timeFrame: One year
Other outcomes:
Locations:
city: Ottawa
country: Canada
facility: Children's Hospital of Eastern Ontario
state: Ontario
Study officials:
affiliation: Children's Hospital of Eastern Ontario
name: Nadya Ben Fadel, MD
role: PRINCIPAL_INVESTIGATOR
References: