Comparing Ultrasound Guided PICC Line Insertion in Neonates With Standard Procedure

NCT ID: NCT02584530

Last Updated: 2020-07-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-07-31
• Study Completion Date: 2020-03-30

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.

Conditions

Ultrasonography, Interventional; Peripheral Venous Catheterization

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Standard procedure group

PICC line insertion using anatomical landmarks guidance and tip placement confirmation by X-ray

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventional group

Ultrasound guidance for PICC line placement and X-ray

Group Type: EXPERIMENTAL

Ultrasound guidance for PICC line placement

Intervention Type: PROCEDURE

Apply ultrasound guidance for PICC line placement and positioning in newborns

Interventions

Ultrasound guidance for PICC line placement

Apply ultrasound guidance for PICC line placement and positioning in newborns

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 1 Day
• Maximum Eligible Age: 28 Days
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Children's Hospital of Eastern Ontario

OTHER

Sponsor Role: lead

Responsible Party

Nadya Ben Fadel

Neonatologist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Nadya Ben Fadel, MD

Role: PRINCIPAL_INVESTIGATOR

Children's Hospital of Eastern Ontario

Locations

Children's Hospital of Eastern Ontario

Ottawa, Ontario, Canada

Countries

Canada

Other Identifiers

20150456

Identifier Type: -

Identifier Source: org_study_id