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

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ClinicalTrials.gov Identifier: NCT02602665
Recruitment Status : Withdrawn (Design was not feasible)
First Posted : November 11, 2015
Last Update Posted : January 18, 2020
Sponsor:
Information provided by (Responsible Party):
Marcus Jarboe, University of Michigan

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.

Condition or disease Intervention/treatment Phase
Vascular Access Complication Procedure: Shallow catheter tip placement Procedure: Deep catheter tip placement Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Central Line Placement Study -EVALUATION OF LINE DEPTH AS A FACTOR IN NEED FOR LINE REPLACEMENT SECONDARY TO MALPOSITION
Estimated Study Start Date : December 1, 2019
Estimated Primary Completion Date : December 28, 2020
Estimated Study Completion Date : December 28, 2021

Arm Intervention/treatment
Experimental: 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.
Procedure: Shallow catheter tip placement
for shallow placement tip of catheter placed 1 vertebral body above to even with the carina

Experimental: 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.
Procedure: Deep catheter tip placement
deep placement catheter tip is placed 1.5 to 2.5 vertebral bodies below the carina




Primary Outcome Measures :
  1. Malposition [ Time Frame: 90 days ]
    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.)



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Ages Eligible for Study:   up to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02602665


Locations
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United States, Michigan
The University of Michigan
Ann Arbor, Michigan, United States, 48109
Sponsors and Collaborators
University of Michigan
Investigators
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Principal Investigator: Marcus Jarboe University of Michigan
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Responsible Party: Marcus Jarboe, Assistant Professor of Surgery and Assistant Professor of Radiology, University of Michigan
ClinicalTrials.gov Identifier: NCT02602665    
Other Study ID Numbers: 98248
First Posted: November 11, 2015    Key Record Dates
Last Update Posted: January 18, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Marcus Jarboe, University of Michigan:
catheter placement