Comparing Ultrasound Guided PICC Line Insertion in Neonates With Standard Procedure

NCT02584530 | Completed

• 1 other identifier: 20150456
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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

Conditions

Ultrasonography, Interventional; Peripheral Venous Catheterization

Keywords

ultrasound; PICC line; neonate

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Number of total venipuncture attempts needed to place a PICC line

  One year

• Number of tip manipulations after complete insertion

  One year

• Proportion of successful tip placement

  One year

Study Arms (2)

Standard procedure group

NO INTERVENTION

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

Interventional group

EXPERIMENTAL

Ultrasound guidance for PICC line placement and X-ray

Procedure: Ultrasound guidance for PICC line placement

Interventions

Ultrasound guidance for PICC line placement PROCEDURE

Apply ultrasound guidance for PICC line placement and positioning in newborns

Interventional group

Eligibility Criteria

• Age: 1 Day - 28 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Children's Hospital of Eastern Ontario: lead

Study Sites (1)

Children's Hospital of Eastern Ontario

Ottawa, Ontario, K1H8L1, Canada

Location

MeSH Terms

Interventions

Catheterization, Peripheral

Intervention Hierarchy (Ancestors)

Catheterization; Therapeutics; Endovascular Procedures; Vascular Surgical Procedures; Cardiovascular Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures; Investigative Techniques

Study Officials

• Nadya Ben Fadel, MD

  Children's Hospital of Eastern Ontario

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Neonatologist

Study Record Dates

• First Submitted: October 21, 2015
• First Posted: October 22, 2015
• Study Start: July 1, 2016
• Primary Completion: March 30, 2020
• Study Completion: March 30, 2020
• Last Updated: July 30, 2020

Record last verified: 2020-07

Locations

CA (1)