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Trial registered on ANZCTR


Registration number
ACTRN12622001402730p
Ethics application status
Submitted, not yet approved
Date submitted
15/09/2022
Date registered
2/11/2022
Date last updated
2/11/2022
Date data sharing statement initially provided
2/11/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Non-Tunneled Catheter (NTC) Tip location: What is the effect on Resource Use for Chronic Kidney Disease patients undergoing Hemodialysis?
Scientific title
Does 2 vs 4 Intercostal space tip location of the Non-Tunneled Catheter tip change resource use due to complications episodes in Chronic Kidney Disease patients undergoing Hemodialysis?
Secondary ID [1] 307972 0
None.
Universal Trial Number (UTN)
U1111-1282-5387.
Trial acronym
Linked study record
The study is linked as a sub-study to registration record ACTRN12619000774123.

Health condition
Health condition(s) or problem(s) studied:
End-Stage Renal Disease 327637 0
Condition category
Condition code
Renal and Urogenital 324725 324725 0 0
Kidney disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The NTC will be inserted percutaneously by 2 trained nephrology specialists with dynamic ultrasound guidance and a modified Seldinger technique; duration of the procedure is 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 assessed by a trained vascular nurse who will be function as an observer during the procedure and register the adherence to the established protocol.
Intervention code [1] 324430 0
Treatment: Devices
Comparator / control treatment
The Classic position group (CG). In this group, the NTC tip will be inserted to be located on the fourth intercostal space (4ICS), using the classical anthropometric measurement; this is the distance between 4ICS and the catheter entrance point (located at an imaginary traversal line that crosses the cricoid cartilage), which will be measured in centimeters with a measure tape and defined as the length at which the NTC should be inserted.
Control group
Active

Outcomes
Primary outcome [1] 332547 0
To compare the use of economic and human resources to solve the composite early complications episodes when NTC the tip is placed in the second intercostal space vs the fourth intercostal space.

The episodes of dysfunction, episodes of repositioning and episodes of relocation of the NTC will be assessed as a composite primary outcome.

Dysfunction is defined as the impossibility of the NTC to provide adequate blood flow (>250 mL/min), assessed by review of medical records.

Repositioning is defined as the need to accommodate the catheter because the tip of the NTC, assessed by anteroposterior radiography, is below the atrio-cava junction.

Relocation is defined as the need to remove and place a new NTC, because the tip of the NTC was lodged 1 cm above the bronchial carina, assessed with an anteroposterior radiography.
Timepoint [1] 332547 0
48 hours post-catheter placement.
Secondary outcome [1] 413876 0
To compare the use of economic resources to solve the early complications derived from the appearance of combined episodes of dysfunction, repositioning and relocation of the CNT when the tip is placed in the second intercostal space vs the fourth intercostal space.

The measurement of the use of economic resources will be determined as a composite outcome considering the cost, measured in US dollars, of the use of extra material to correct combined episodes of dysfunction, repositioning, relocation of NTC for hemodialysis, the extra cost involves the sum of NTC, chest radiography, the extra material to place the NTC, will be determined by review of medical records. In our setting, the cost of a NTC for hemodialysis is US$100, the cost of a chest radiography is US$25, and the cost of the material to place the NTC is US$30.
Timepoint [1] 413876 0
48 hours post-catheter placement.
Secondary outcome [2] 413877 0
To compare the use of human resources to solve the early complications derived from combined the appearance of episodes of dysfunction, repositioning and repositioning of the CNT when the NTC tip is placed in the second intercostal space vs the fourth intercostal space.

The measurement of the use of human resources will be evaluated as a composite outcome considering the use of time measured in minutes necessary to correct the the combined episodes of dysfunction, repositioning, relocation of NTC for hemodialysis, by the nursing and medical staff. This will be determined by review of medical records.

Time in minutes used by the doctor to solve the complications derived from the placement of the hemodialysis CNT, will be determined by review of medical records.

Time in minutes used by the nurse to solve the complications derived from the placement of the hemodialysis CNT, will be determined by review of medical records.
Timepoint [2] 413877 0
48 hours post-catheter placement.

Eligibility
Key inclusion criteria
Patients over 18 years of age who have accepted the placement of the NTC for hemodialysis.
Patients who have signed the informed consent.
Patients who can remain seated for the chest X-ray in a protocolized manner.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients who cannot collaborate in the performance of chest 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Sealed opaque envelopes.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software generated by radioactive decay.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
The calculated sample was determined by the ratio difference formula resulting in 116 patients, taking as reference a power of 80% and alpha of 5. The data will be reported as mean and standard deviation or median and range, accordingly to data normality distribution. To compare the standard deviation, a Fischer test will be applied in the correlation of coefficients. Confidence intervals of 95% will be used. Evaluation of qualitative variables through Chi square (tables 2x2 or 2x3) where the difference was established when the p was less than or equal to 0.05.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
20/12/2022
Actual
Date of last participant enrolment
Anticipated
2/01/2023
Actual
Date of last data collection
Anticipated
27/02/2023
Actual
Sample size
Target
116
Accrual to date
Final
Recruitment outside Australia
Country [1] 25010 0
Mexico
State/province [1] 25010 0
Coahuila

Funding & Sponsors
Funding source category [1] 312241 0
University
Name [1] 312241 0
Universidad Autonoma de Coahuila
Country [1] 312241 0
Mexico
Primary sponsor type
University
Name
Universidad Autonoma de Coahuila
Address
Boulevard Centenario 901, Villa de Fuente, Piedras Negras, Coahuila, México, PC 26090.
Country
Mexico
Secondary sponsor category [1] 313777 0
None
Name [1] 313777 0
Address [1] 313777 0
Country [1] 313777 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 311617 0
Universidad Autonoma de Coahuila Ethics Comittee
Ethics committee address [1] 311617 0
Ethics committee country [1] 311617 0
Mexico
Date submitted for ethics approval [1] 311617 0
01/09/2022
Approval date [1] 311617 0
Ethics approval number [1] 311617 0
Pending

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 121734 0
Dr Hector Raul Ibarra Sifuentes
Address 121734 0
Boulevard Centenario 901, Villa de Fuente, Piedras Negras, Coahuila, Mexico, PC 26090.
Country 121734 0
Mexico
Phone 121734 0
+528787842200
Fax 121734 0
Email 121734 0
ibarra.hector@uadec.edu.mx
Contact person for public queries
Name 121735 0
Hector Raul Ibarra Sifuentes
Address 121735 0
Boulevard Centenario 901, Villa de Fuente, Piedras Negras, Coahuila, Mexico, PC 26090.
Country 121735 0
Mexico
Phone 121735 0
+528787842200
Fax 121735 0
Email 121735 0
ibarra.hector@uadec.edu.mx
Contact person for scientific queries
Name 121736 0
Hector Raul Ibarra Sifuentes
Address 121736 0
Boulevard Centenario 901, Villa de Fuente, Piedras Negras, Coahuila, Mexico, PC 26090.
Country 121736 0
Mexico
Phone 121736 0
+528787842200
Fax 121736 0
Email 121736 0
ibarra.hector@uadec.edu.mx

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Human and economy resource use, rate of dysfunction, repositioning and relocation of the NTC tip for hemodialysis in the classic and intervention group.
When will data be available (start and end dates)?
From December 30th 2023 to December 30th 2024.
Available to whom?
Researchers who contact the corresponding author.
Available for what types of analyses?
Statistical
How or where can data be obtained?
Access subject to approvals by Principal Investigator, contacted in this email ibarra.hector@uadec.edu.mx


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.