Dialysis Catheter; MalpositionNCT05935475
A Comparative Study for Ideal Positioning of Dialysis Catheter Tip in Pediatric Patients
A study testing Anatomical landmark guided dialysis catheter insertion and ECG guided dialysis catheter insertion in people with Dialysis Catheter; Malposition, run by Tanta University at 1 site in Egypt.
Trial summary
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? Read more about this study
- Who is it for?
- Ages 5 to 18 years
- Conditions the study is for
- Dialysis Catheter; Malposition
- What is being tested?
- Anatomical landmark guided dialysis catheter insertion and ECG guided dialysis catheter insertion
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteEgypt
- Study dates
- 28 May 2023to 20 Jan 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Pediatric patients from 5 to 18 years require dialysis catheter insertion for any indication as acute or chronic renal failure.
Who cannot join
- Patients with coagulopathy.
- Patients with infection.
- Patients with cardiac arrhythmia or pacemaker
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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?
Read the 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:
- History taking including the cause of dialysis.
- Clinical examination.
- Investigations:
- Complete blood picture
- Bleeding and clotting time.
- International normalized ratio
- Serum potassium
- Serum creatinine, blood urea level.
- 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.
- Conditions
- Dialysis Catheter; Malposition
- Being tested
- Anatomical landmark guided dialysis catheter insertion, ECG guided dialysis catheter insertion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anatomical landmark guided dialysis catheter insertionProcedure or surgery
Also called ultrasound guided dialysis catheter insertion using anatomical method
.: 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.
ECG guided dialysis catheter insertionProcedure or surgery
Also called ultrasound guided dialysis catheter insertion using ECG 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
| Study group | Role | What they receive |
|---|---|---|
| group A | Active comparator | 75 children and adolescent will insert dialysis catheter using the anatomical landmark technique Receives: Procedure: Anatomical landmark guided dialysis catheter insertion |
| group B | Active comparator | 75 children and adolescent will insert dialysis catheter using the ECG guided technique Receives: Procedure: ECG guided dialysis catheter insertion |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: one year
Secondary outcomes (1)
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.
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2023
- Study start28 May 2023
- Primary completion20 Jan 2024
- Study completion20 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dialysis Catheter; MalpositionStudies of the same condition, open and under way.
- More trials run by Tanta UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sara Mabrouk Elghoul, Tanta University
- Investigators
- Sara Mabrouk Mohamed Elghoul, Principal investigator, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05935475
- Sponsor's protocol ID
- 36264PR196/5/23
- Status last verified
- Jan 2024
- First submitted
- 20 Jun 2023
- Last updated
- 24 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: no individual participant data will be shared
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparative Study Between Electrocardiography Guided Technique Versus Anatomical Based Technique for Ideal Positioning of Dialysis Catheter Tip in Pediatric Patients
- ClinicalTrials.gov ID
- NCT05935475
- Acronym / sponsor ID
- 36264PR196/5/23
- Conditions
- Dialysis Catheter; Malposition
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 28 May 2023 (actual)
- Primary completion
- 20 Jan 2024 (actual)
- Study completion
- 20 Jan 2024 (actual)
- First posted
- 7 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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?
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:
- History taking including the cause of dialysis.
- Clinical examination.
- Investigations:
- Complete blood picture
- Bleeding and clotting time.
- International normalized ratio
- Serum potassium
- Serum creatinine, blood urea level.
- 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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| group A | Active comparator | Procedure: Anatomical landmark guided dialysis catheter insertion75 children and adolescent will insert dialysis catheter using the anatomical landmark technique |
| group B | Active comparator | Procedure: ECG guided dialysis catheter insertion75 children and adolescent will insert dialysis catheter using the ECG guided technique |
Who may qualify
- Ages
- 5 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Pediatric patients from 5 to 18 years require dialysis catheter insertion for any indication as acute or chronic renal failure.
Key exclusion criteria (3 listed)
- Patients with coagulopathy.
- Patients with infection.
- Patients with cardiac arrhythmia or pacemaker
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Anatomical landmark guided dialysis catheter insertionAlso: ultrasound guided dialysis catheter insertion using anatomical method.: 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. | Procedure or surgery | group A |
| ECG guided dialysis catheter insertionAlso: ultrasound guided dialysis catheter insertion using ECG techniqueafter 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 | Procedure or surgery | group B |
Primary outcome
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
1 secondary outcome
Post insertion adverse events
Time frame: one year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jan 2024.
- Individual participant dataSharing planned: No. no individual participant data will be shared
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sara Mabrouk Mohamed Elghoul principal investigator
Tanta University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Anatomical landmark guided dialysis catheter insertion and ECG guided dialysis catheter insertion in people with Dialysis Catheter; Malposition, run by Tanta University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The ideal tip position of dialysis catheter (time frame: one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jan 2024.