Central Line Placement-EVALUATION OF LINE DEPTH AS A FACTOR IN NEED FOR LINE REPLACEMENT SECONDARY TO MALPOSITION

NCT02602665 | Withdrawn

• 1 other identifier: 98248
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

This is a single center, randomized, controlled trial in which tunneled central line catheters will be placed in two distinct, select positions. The catheter tip position will then be followed up prospectively after placement to determine whether there is any malpositioning of the tip and if one placement is better than the other.

Conditions

Vascular Access Complication

Keywords

catheter placement

Outcome Measures

Primary Outcomes (1)

• Malposition

  The primary outcome measure of this study is to determine whether the position of the tip during central line placement plays a role in malposition during further evaluation of these patients. This will be determined with chest X-ray done at or within 90 days after line insertion. All non-ultrasound guided lines and those placed by cut down procedure will be tallied in a prospective manner to calculate the number of lines placed without radiological guidance. Number of attempts required to place the line (number of times the needle is removed exterior to the skin, i.e. number of skin punctures.)

  90 days

Study Arms (2)

Shallow catheter tip placement

EXPERIMENTAL

Patients randomized to shallow tip placement will have the tip of the catheter placed approximately one vertebral body above to even with the carina.

Procedure: Shallow catheter tip placement

Deep catheter tip placement

EXPERIMENTAL

Patients randomized to deep tip placement will have the tip of the catheter placed 1.5 to 2.5 vertebral bodies below the carina.

Procedure: Deep catheter tip placement

Interventions

Shallow catheter tip placement PROCEDURE

for shallow placement tip of catheter placed 1 vertebral body above to even with the carina

Shallow catheter tip placement

Deep catheter tip placement PROCEDURE

deep placement catheter tip is placed 1.5 to 2.5 vertebral bodies below the carina

Deep catheter tip placement

Eligibility Criteria

• Age: Up to 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Children from 0-18 years of age needing a tunneled central line (port or broviac) for treatment of their disease.

You may not qualify if:

• Wire exchanged lines
• Non ultrasound placed lines, femoral lines, saphenous vein lines, and cut downs
• Short gut syndrome children \< 1 year of age

Sponsors & Collaborators

• University of Michigan: lead

Study Sites (1)

The University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

Study Officials

• Marcus Jarboe

  University of Michigan

  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: Assistant Professor of Surgery and Assistant Professor of Radiology

Study Record Dates

• First Submitted: November 9, 2015
• First Posted: November 11, 2015
• Study Start: December 1, 2019
• Primary Completion: December 28, 2020
• Study Completion: December 28, 2021
• Last Updated: January 18, 2020

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)