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

Vascular Access Complication Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02602665
• Other study ID #: 98248
• Status: Withdrawn
• Phase: N/A
• Start date: December 1, 2019
• Est. completion date: December 28, 2021

Study information

• Verified date: January 2020
• Source: University of Michigan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Optimal central line placement is vital to catheter longevity. If malpositioned, the catheter may need to get replaced, potentially causing additional morbidity to the patient and additional cost to the healthcare system. In our department, a retrospective study looking at catheter tip position at inital placement and incidence of malposition. In this study, 404 catheter placements were reviewed, and a total of 162 (40.1%) were replaced. Out of the 162 replaced, 36 (22.2%) were replaced secondary to malposition. From this study, we were also able to conclude that catheter tips placed in a deeper position, approximately one and a half vertebral bodies below the carina, were less likely to be malpositioned in the future upon radiographic review.

Current standard of care does not dictate positioning of the line in a specific loacation. In the presence of these findings, we are proposing to conduct a single center randomized control trial in which tunneled central line catheters will be placed in two distinct, select positions. After informed consent is obtained from the patient and family, they will be randomized to one of two treatment groups. The shallow group will have the tip of the catheter located approximately one vertebral body above the carina. The deep group will have the catheter tip placed 1.5 to 2.5 vertebral bodies below the carina. Central line placement will be performed under fluoroscopy in the operating room to optimize catheter placement. Chest X ray in the post operative area will be used to confirm catheter tip position. The catheter tip position will then be followed up prospectively using chest X ray films at or within three months after placement to determine whether there is any malpositioning of the tip.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 28, 2021
• Est. primary completion date: December 28, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A to 18 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• Wire exchanged lines

• Non ultrasound placed lines, femoral lines, saphenous vein lines, and cut downs

• Short gut syndrome children < 1 year of age

Related Conditions & MeSH terms

• Vascular Access Complication

Intervention

Procedure:
• Shallow catheter tip placement
for shallow placement tip of catheter placed 1 vertebral body above to even with the carina
• Deep catheter tip placement
deep placement catheter tip is placed 1.5 to 2.5 vertebral bodies below the carina

Locations

Country	Name	City	State
United States	The University of Michigan	Ann Arbor	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
University of Michigan

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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