A Comparative Study for Ideal Positioning of Dialysis Catheter Tip in Pediatric Patients

A Comparative Study Between Electrocardiography Guided Technique Versus Anatomical Based Technique for Ideal Positioning of Dialysis Catheter Tip in Pediatric Patients

This prospective study will be conducted to compare between the efficacy of both ECG-guided technique and anatomical landmark technique to detect the ideal positioning of dialysis catheter tip and whether it will decrease the radiation exposure or no?

Study Overview

• Status: Completed
• Conditions: Dialysis Catheter; Malposition
• Intervention / Treatment: Procedure: Anatomical landmark guided dialysis catheter insertion; Procedure: ECG guided dialysis catheter insertion

Detailed Description

This study will be conducted on 150 children and adolescents with end stage renal disease or any cause for urgent hemodialysis at our nephrology Unit at TUH during the period of the study and classified into two equal groups:

Group A (control): insertion of dialysis catheter using the anatomical landmark-guided technique.

Group B: insertion of dialysis catheter using the ECG-guided technique. Participants will be randomly assigned using an internet-based computer program (http://www.randomizer.org) either to the anatomical landmark group or to the ECG group.

All patients included in the study will be subjected to:

1. History taking including the cause of dialysis.
2. Clinical examination.

3. Investigations:

   • Complete blood picture
   • Bleeding and clotting time.
   • International normalized ratio
   • Serum potassium
   • Serum creatinine, blood urea level.
4. Procedure technique:

A single anesthiologist will perform the procedures in both groups under complete a septic condition after consent taking from the child guardians. All participants will be cannulated in the right internal jugular vein (IJV). The participants were placed in Trendelenburg position and the dialysis catheter will be inserted using catheter-over-guidewire technique (the Seldinger technique) with the aid of ultrasound for scanning the neck by the superficial probe (7-13 MHz).

In the ECG-guided technique, after inserting the dialysis catheter into right IJV, the guidewire will be then withdrawn until the tip to be exactly positioned at the entry of the Superior Vena Cava in the right atrium. This will be ECG guided: the p wave appears as biphasic wave in the RA then the catheter will be withdrawn at 0.5 cm intervals until the P-wave returned to a normal configuration. At that point, the catheter will be secured at the skin with suture and dressed with a transparent dressing.

In the anatomical landmark technique: Before insertion, the catheter depth was calculated from the insertion point to the catheter tip point (midway the vertical line from the clavicular head of sternocleidomastoid to inter nipple line.

After insertion of the dialysis catheter, the patient will be monitored for any hemodynamic deterioration and a repeat ultrasound-chest was done to rule out pneumothorax. An anterior-posterior CXR in supine position will be taken in all patients, to confirm the placement and positioning of the dialysis catheter.

The whole length of the SVC was defined on CXR as the area from the lower border on the first right costal cartilage close to the sternum to the conventional radiographic SVC-RA junction.

Post insertion CXR done in both groups to detect the adequate insertion length of the dialysis catheter, frequency of CXR for repositioning, time to dialysis catheter placement, and post procedural complications will be recorded.

• Study Type: Interventional
• Enrollment (Actual): 150
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Tanta, Egypt
    • Sara Mabrouk Mohamed Elghoul

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Pediatric patients from 5 to 18 years require dialysis catheter insertion for any indication as acute or chronic renal failure.

Exclusion Criteria:

• Patients with coagulopathy.
• Patients with infection.
• Patients with cardiac arrhythmia or pacemaker

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: group A; 75 children and adolescent will insert dialysis catheter using the anatomical landmark technique	Procedure: Anatomical landmark guided dialysis catheter insertion; .: Before insertion, the catheter depth was calculated from the insertion point to the catheter tip point (midway the vertical line from the clavicular head of sternocleidomastoid to inter nipple line.; Other Names: ultrasound guided dialysis catheter insertion using anatomical method
Active Comparator: group B; 75 children and adolescent will insert dialysis catheter using the ECG guided technique	Procedure: ECG guided dialysis catheter insertion; after inserting the dialysis catheter into right IJV, the guidewire will be then withdrawn until the tip to be exactly positioned at the entry of the Superior Vena Cava in the right atrium. This will be ECG guided: the p wave appears as biphasic wave in the RA then the catheter will be withdrawn at 0.5 cm intervals until the P-wave returned to a normal configuration. (At that point, the catheter will be secured at the skin with suture and dressed with a transparent dressing; Other Names: ultrasound guided dialysis catheter insertion using ECG technique

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The ideal tip position of dialysis catheter	all the participant will be cannulated in the right internal jugular vein by the Seldinger technique with the aid of ultrasound, In the ECG-guided technique,the wire will be withdrawn until positioned at the entry of the Superior Vena Cava in the right atrium and the P-wave returned to a normal configuration.In the anatomical landmark technique: Before insertion, the catheter depth was calculated from the insertion point to a point (midway the vertical line from the clavicular head of sternocleidomastoid to inter nipple line.An anterior-posterior CXR in supine position will be taken in all patients, to confirm the placement and positioning of the dialysis catheterThe whole length of the SVC was defined on CXR as the area from the lower border on the first right costal cartilage close to the sternum to the conventional radiographic SVC-RA junction	one year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Post insertion adverse events	After insertion of the dialysis catheter, the patient will be monitored for any hemodynamic deterioration and a repeat ultrasound-chest was done to rule out pneumothorax.	one year

Collaborators and Investigators

• Sponsor: Tanta University
• Investigators: Principal Investigator: Sara Mabrouk Mohamed Elghoul, Tanta University

Study record dates

Study Major Dates

• Study Start (Actual): May 28, 2023
• Primary Completion (Actual): January 20, 2024
• Study Completion (Actual): January 20, 2024

Study Registration Dates

• First Submitted: June 20, 2023
• First Submitted That Met QC Criteria: June 29, 2023
• First Posted (Actual): July 7, 2023

Study Record Updates

• Last Update Posted (Estimated): January 24, 2024
• Last Update Submitted That Met QC Criteria: January 22, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: 36264PR196/5/23

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: no individual participant data will be shared

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No