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

January 22, 2024 updated by: Sara Mabrouk Elghoul, Tanta University

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
150

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Egypt
      • Tanta, Egypt
        • Sara Mabrouk Mohamed Elghoul

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
The ideal tip position of dialysis catheter
Time Frame: one year
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Post insertion adverse events
Time Frame: one year
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Tanta University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Sara Mabrouk Mohamed Elghoul, Tanta University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 28, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 20, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 20, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 20, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 29, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 7, 2023

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 24, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 22, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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