Comparing Ultrasound Guided PICC Line Insertion in Neonates With Standard Procedure

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Ultrasonography, Interventional, Peripheral Venous Catheterization

Intervention / Treatment
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* Procedure: Ultrasound guidance for PICC line placement


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 1 Day
Maximum Age: 28 Days

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ultrasound, PICC line, neonate