Peripherally Inserted Central Catheter Insertion Site and Complication Rate in Neonates

Peripherally Inserted Central Venous Catheter Insertion Site and Complication Rates in Neonates

This study examines whether there is an association between the PICC insertion site and the complications necessitating PICC removal in neonates admitted to neonatal intensive care unit.

Study Overview

• Status: Recruiting
• Conditions: Catheterization, Peripheral
• Intervention / Treatment: Device: Peripherally Inserted Central Venous Cather (PICC)

• Study Type: Interventional
• Enrollment (Anticipated): 320
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Amuchou Soraisham, MD; Phone Number: 403-944-8101; Email: amuchou.soraisham@ahs.ca

Study Locations

• Canada
  • Alberta
    • Calgary, Alberta, Canada, T2N2T9
      • Recruiting
      • Foothills Medical Centre
      • Contact: Amuchou Soraisham, MD, DM, FRCPC; Phone Number: 403-944-8101; Email: amuchou.soraisham@ahs.ca
      • Contact: Harish Amin, MBBS, FRCPC; Phone Number: 403-955-7513; Email: harish.amin@ahs.ca
      • Principal Investigator: Amuchou Soraisham, MD
      • Sub-Investigator: Sumesh Thomas, MD
      • Sub-Investigator: Harish Amin, MD
      • Sub-Investigator: Kim Pearson, RN
      • Sub-Investigator: Norma Oliver, RN

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 4 months (Child)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Neonates of all gestational ages admitted to Foothills Medical Centre and Alberta Children's Hospital Neonatal Intensive Care Unit (NICU)
2. Peripherally inserted central venous catheter (PICC) line insertion planned as part of NICU care
3. Venous access available in both upper(above umbilicus) and lower body

Exclusion Criteria:

1. Local infection at potential site of insertion
2. Hemangioma, lymphangioma or malformations in the region of insertion
3. Major chromosomal anomalies

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Upper Extremity Insertion; Peripherally Inserted Central Venous Cather (PICC) inserted in upper extremity	Device: Peripherally Inserted Central Venous Cather (PICC); Location of the PICC insertion will be randomized and compared
Experimental: Lower Extremity Insertion; Peripherally Inserted Central Venous Cather (PICC) inserted in lower extremity	Device: Peripherally Inserted Central Venous Cather (PICC); Location of the PICC insertion will be randomized and compared

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Primary outcome is the presence of any complication which necessitates PICC removal	Line infiltration will be defined as extravasation of fluid into soft tissue around the region of the catheter tip. Line occlusion will be defined as inability to infuse fluid, resulting in removal of line. Phlebitis will be defined as presence of a linear red streak developing along the superficial veins from the catheter insertion site. Line associated thrombosis will be defined as ultrasound proven evidence of an occlusive thrombus in an anatomic location in proximity to the site of PICC.CLABSI will be defined according to Center for Disease Control definitions 26, that is, (1) confirmed primary bloodstream infection with (2) one of following clinical signs of infection (fever, hypothermia, apnea, or bradycardia) and (3) presence of central catheter at the time of or within 48 hours before the onset of the infection. Major life-threatening complications will include pleural effusion, pericardial effusion and cardiac tamponade, retroperitoneal extravasation.	Through study completion, within 4 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Secondary outcome will be time to complication post insertion	This will be defined as the interval between PICC line insertion and first detection of complication post insertion, expressed in days.	Through study completion, within 4 weeks

Collaborators and Investigators

• Sponsor: University of Calgary
• Investigators: Principal Investigator: Amuchou Soraisham, MD, University of Calgary

Study record dates

Study Major Dates

• Study Start (Actual): October 19, 2018
• Primary Completion (Anticipated): December 31, 2025
• Study Completion (Anticipated): December 31, 2025

Study Registration Dates

• First Submitted: March 14, 2018
• First Submitted That Met QC Criteria: March 21, 2018
• First Posted (Actual): March 23, 2018

Study Record Updates

• Last Update Posted (Actual): May 19, 2023
• Last Update Submitted That Met QC Criteria: May 17, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: REB17-2371

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No