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Non-Tunneled Catheter (NTC) Tip location on Chronic Kidney Disease patients undergoing Hemodialysis.

Does 2 vs 4 Intercostal space tip location of the Non-Tunneled Catheter tip change episode rates in Chronic Kidney Disease patients undergoing Hemodialysis?

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12619000774123
Enrollment
165
Registered
2019-05-24
Start date
2019-05-30
Completion date
2020-01-15
Last updated
2020-02-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Non-tunnelled catheters (NTC) for hemodialysis are an indispensable vascular access in patients in need of hemodialysis, especially urgently. The insertion method used for the placement of NTC can reduce serious complications. Authors design a randomized clinical trial with adult patients of the University Hospital, of the Autonomous University of Nuevo Leon, Monterrey, Mexico, who required emergency hemodialysis by NTC. The calculated sample size is 153 patients. The NTC will be inserted percutaneously by 2 trained nephrology fellows with the guidance of ultrasound and a modified Seldinger technique. The placement of the NTC tip will be randomized to the fourth intercostal space (4ICS) and the intervention method located in the second intercostal space (2ICS). The main outcome is to compare the number of dysfunction, repositioning and relocation composite episodes of the NTC for Hemodialysis tip placement on the 4ICS and the 2ICS.

Interventions

The NTC will be inserted percutaneously by 2 trained nephrology fellows with the guidance of ultrasound and a modified Seldinger technique; duration of the procedure 30- 45 minutes and will be realized on an sterile environment on a designated procedure room. The placement of the NTC tip will be randomized to the classic method located in the fourth intercostal space (4ICS) and the intervention method located in the second intercostal space (2ICS). The Intervention position group (IG). In th

The NTC will be inserted percutaneously by 2 trained nephrology fellows with the guidance of ultrasound and a modified Seldinger technique; duration of the procedure 30- 45 minutes and will be realized on an sterile environment on a designated procedure room. The placement of the NTC tip will be randomized to the classic method located in the fourth intercostal space (4ICS) and the intervention method located in the second intercostal space (2ICS). The Intervention position group (IG). In this group, the NTC tip will be inserted to be located on the second intercostal space (2ICS). The distance between 2ICS and the catheter entrance point (located at an imaginary traversal line that crosses the cricoid cartilage), will be measured in centimeters with a measure tape and defined as the length at which the NTC should be inserted. The adherence to the intervention will be assed by a trained vascular nurse who will be function as an observer during the procedure and register the adherence to the established protocol.

Sponsors

Hospital Universitario, Dr. José E. González, Universidad Autónoma de Nuevo León
Lead SponsorHospital

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Blinded (masking used) (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

Inclusion criteria: Patients over 18-years old who have accepted the placement of the NTC for hemodialysis. Patients who have signed the informed consent. Patients who can stay seated for the chest radiograph in a protocoled manner.

Exclusion criteria

Exclusion criteria: Patients who cannot collaborate in the performance of chest PA radiography or NTC placement. Patients who had an immediate complication during the placement, related to puncture such as pneumothorax, hemopneumothorax, catheter placement in the carotid artery, malpositioning of the NTC, hemomediastinum, air embolism. The use of other than the right internal jugular vein for vascular access to NTC placement.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 22, 2026