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Completed

NCT Number: NCT02584530

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

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Key information

Age range

1 day–28 day

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Children's Hospital of Eastern Ontario

Ottawa, Ontario, K1H8L1, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ultrasound guidance for PICC line placement

Procedure

Apply ultrasound guidance for PICC line placement and positioning in newborns

Primary outcomes

  1. Time to complete the standard versus the US-guided procedure

    Time frame: one year

    Comparison between total time of procedure with standard approach vs US guidance measured in minutes.

Secondary outcomes

  1. Number of total venipuncture attempts needed to place a PICC line

    Time frame: One year

    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

  2. Number of tip manipulations after complete insertion

    Time frame: One year

    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.

  3. Proportion of successful tip placement

    Time frame: One year

    Total number of correct position of PICC line tip will be documented in both groups and then compared to control.

Sponsors and collaborators

Lead sponsor

Children's Hospital of Eastern Ontario

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2020
Study completion
2020
First posted
Oct 22, 2015
Registry last updated
Jul 30, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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