Comparing Ultrasound Guided PICC Line Insertion in Neonates With Standard Procedure

A Randomized Controlled Trial Comparing Ultrasound Guided PICC Line Insertion in Neonates With Standard Procedure

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

Study Overview

• Status: Completed
• Conditions: Peripheral Venous Catheterization; Ultrasonography, Interventional
• Intervention / Treatment: Procedure: Ultrasound guidance for PICC line 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.

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Ottawa, Ontario, Canada, K1H8L1
      • Children's Hospital of Eastern Ontario

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 day to 4 weeks (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Standard procedure group; PICC line insertion using anatomical landmarks guidance and tip placement confirmation by X-ray
Experimental: Interventional group; Ultrasound guidance for PICC line placement and X-ray	Procedure: Ultrasound guidance for PICC line placement; Apply ultrasound guidance for PICC line placement and positioning in newborns

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to complete the standard versus the US-guided procedure	Comparison between total time of procedure with standard approach vs US guidance measured in minutes.	one year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of total venipuncture attempts needed to place a PICC line	Number of venipuncture attempts will be documented per patient through the whole duration of study and then both groups will be compared differences in number	One year
Number of tip manipulations after complete insertion	Number of manipulations of tip line for adequate placement will be documented on each patient and then compared against control group to assess for differences in number.	One year
Proportion of successful tip placement	Total number of correct position of PICC line tip will be documented in both groups and then compared to control.	One year

Collaborators and Investigators

• Sponsor: Children's Hospital of Eastern Ontario
• Investigators: Principal Investigator: Nadya Ben Fadel, MD, Children's Hospital of Eastern Ontario

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2016
• Primary Completion (Actual): March 30, 2020
• Study Completion (Actual): March 30, 2020

Study Registration Dates

• First Submitted: October 21, 2015
• First Submitted That Met QC Criteria: October 21, 2015
• First Posted (Estimate): October 22, 2015

Study Record Updates

• Last Update Posted (Actual): July 30, 2020
• Last Update Submitted That Met QC Criteria: July 29, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Keywords: ultrasound; neonate; PICC line
• Other Study ID Numbers: 20150456