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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Recruitment Status : Withdrawn (Design was not feasible)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

Tracking Information
First Submitted Date  ICMJE November 9, 2015
First Posted Date  ICMJE November 11, 2015
Last Update Posted Date January 18, 2020
Estimated Study Start Date  ICMJE December 1, 2019
Estimated Primary Completion Date December 28, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 9, 2015)
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.)
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Central Line Placement-EVALUATION OF LINE DEPTH AS A FACTOR IN NEED FOR LINE REPLACEMENT SECONDARY TO MALPOSITION
Official Title  ICMJE Central Line Placement Study -EVALUATION OF LINE DEPTH AS A FACTOR IN NEED FOR LINE REPLACEMENT SECONDARY TO MALPOSITION
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Condition  ICMJE Vascular Access Complication
Intervention  ICMJE
  • Procedure: Shallow catheter tip placement
    for shallow placement tip of catheter placed 1 vertebral body above to even with the carina
  • Procedure: Deep catheter tip placement
    deep placement catheter tip is placed 1.5 to 2.5 vertebral bodies below the carina
Study Arms  ICMJE
  • 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.
    Intervention: Procedure: Shallow catheter tip placement
  • 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.
    Intervention: Procedure: Deep catheter tip placement
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Withdrawn
Actual Enrollment  ICMJE
 (submitted: January 14, 2020)
0
Original Estimated Enrollment  ICMJE
 (submitted: November 9, 2015)
130
Estimated Study Completion Date  ICMJE December 28, 2021
Estimated Primary Completion Date December 28, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE up to 18 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02602665
Other Study ID Numbers  ICMJE 98248
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Marcus Jarboe, University of Michigan
Study Sponsor  ICMJE University of Michigan
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Marcus Jarboe University of Michigan
PRS Account University of Michigan
Verification Date January 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP