Clinical trial NCT02602665: Central Line Placement-EVALUATION OF LINE DEPTH AS A FACTOR IN NEED FOR LINE REPLACEMENT SECONDARY TO MALPOSITION
Official title: Central Line Placement Study -EVALUATION OF LINE DEPTH AS A FACTOR IN NEED FOR LINE REPLACEMENT SECONDARY TO MALPOSITION
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Vascular Access Complication
Keywords: catheter placement
Lead sponsor: University of Michigan
Sponsor class: OTHER
First posted: 2015-11-11
Enrollment: 0
Sex: ALL
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Malposition
timeFrame: 90 days
Secondary outcomes:
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: The University of Michigan
state: Michigan
Study officials:
affiliation: University of Michigan
name: Marcus Jarboe
role: PRINCIPAL_INVESTIGATOR
References: