Peripherally Inserted Central Catheter Insertion Site and Complication Rate in Neonates

Not Applicable

Recruiting

• Conditions: Catheterization, Peripheral
• Interventions: Device: Peripherally Inserted Central Venous Cather (PICC)

• Registration Number: NCT03474978
• Lead Sponsor: University of Calgary

Brief Summary

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2018-03-14
• Study First Submitted QC: 2018-03-21
• Study First Posted: 2018-03-23
• Study Start: 2018-10-19
• Status Verified: 2023-05
• Last Update Submitted: 2023-05-17
• Last Update Posted: 2023-05-19
• Primary Completion: 2025-12-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 320

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

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Upper Extremity Insertion	Peripherally Inserted Central Venous Cather (PICC)	Peripherally Inserted Central Venous Cather (PICC) inserted in upper extremity
Lower Extremity Insertion	Peripherally Inserted Central Venous Cather (PICC)	Peripherally Inserted Central Venous Cather (PICC) inserted in lower extremity

Primary Outcome Measures

Name	Time	Method
Primary outcome is the presence of any complication which necessitates PICC removal	Through study completion, within 4 weeks	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.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Foothills Medical Centre; 🇨🇦 Calgary, Alberta, Canada