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

NCT ID: NCT02602665

Last Updated: 2020-01-18

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-12-01
• Study Completion Date: 2021-12-28

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.

Detailed 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.

Conditions

Vascular Access Complication

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Shallow catheter tip placement

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

Group Type: EXPERIMENTAL

Shallow catheter tip placement

Intervention Type: PROCEDURE

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

Deep catheter tip placement

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

Group Type: EXPERIMENTAL

Deep catheter tip placement

Intervention Type: PROCEDURE

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

Interventions

Shallow catheter tip placement

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

Intervention Type: PROCEDURE

Deep catheter tip placement

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

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Michigan

OTHER

Sponsor Role: lead

Responsible Party

Marcus Jarboe

Assistant Professor of Surgery and Assistant Professor of Radiology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Marcus Jarboe

Role: PRINCIPAL_INVESTIGATOR

University of Michigan

Locations

The University of Michigan

Ann Arbor, Michigan, United States

Countries

United States

Other Identifiers

98248

Identifier Type: -

Identifier Source: org_study_id