Comparing Ultrasound Guided PICC Line Insertion in Neonates With Standard Procedure

Peripheral Venous Catheterization Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02584530
• Other study ID #: 20150456
• Status: Completed
• Phase: N/A
• Start date: July 2016
• Est. completion date: March 30, 2020

Study information

• Verified date: July 2020
• Source: Children's Hospital of Eastern Ontario
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: March 30, 2020
• Est. primary completion date: March 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 28 Days

Eligibility

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

Related Conditions & MeSH terms

• Peripheral Venous Catheterization
• Ultrasonography, Interventional

Intervention

Procedure:
• Ultrasound guidance for PICC line placement
Apply ultrasound guidance for PICC line placement and positioning in newborns

Locations

Country	Name	City	State
Canada	Children's Hospital of Eastern Ontario	Ottawa	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Children's Hospital of Eastern Ontario

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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