Central Line ComplicationNCT06652490
Short-axis/out-of-plane Approach Versus Oblique- Axis Approach for US Guided IJV Catheterization in Infants.
An observational study of Central Line Complication, run by Ain Shams University at 1 site in Egypt.
Trial summary
The investigators will measure and compare the rate of acute complications, success rate, number of attempts to successful cannulation between ultrasound-guided short axis approach and oblique axis approach during internal jugular venous catheterization in infants. Read more about this study
- Who is it for?
- Ages 1 month to 12 monthsHealthy volunteers can take part
- Conditions the study is for
- Central Line Complication
- What is being tested?
- Short-axis/out-of-plane approach versus oblique- axis approach for ultrasound-guided internal jugular venous catheter.
- Type of treatment
- Surgery or procedure
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Apr 2024to 15 Sep 2024
- How long will I take part?
- 2 Days
- Phase
- Observational
- 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 1 month to 12 months
- All sexes
- Healthy volunteers accepted
- Child
Study population: This study will be carried out on infants who require central venous access through IJV as part of their management in operating room (OR) if they consented to be part of the study from their parents.
Who may be able to join
- Age between 1 month and 12 months
- Physical status: patients requiring CVC in their management
Who cannot join
- patient's parents refuse to do the study
- Coagulopathy (INR > 1.5, platelets count < 50.000), use of anti-coagulant or anti platelet therapy) (Sunny et al, 2022)
- Infection, wounds or subcutaneous hematoma close to the puncture site
- history of previous surgical intervention at the cannulation site
- subcutaneous emphysema, penetrating neck trauma or cervical trauma
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Short-axis/out-of-plane Approach Versus Oblique- Axis Approach for Ultrasound-guided Internal Jugular Venous Catheterization in Infants.
The investigators will measure and compare the rate of acute complications, success rate, number of attempts to successful cannulation between ultrasound-guided short axis approach and oblique axis approach during internal jugular venous catheterization in infants.
Read the detailed description
- pre-procedure settings: The history will be obtained from patient's parents. Investigations will be checked to all patients as (complete blood picture and coagulation profile) to avoid coagulopathy and thrombocytopenia. All patients will be attached to standard monitoring (blood pressure (non-invasive), heart rate, and pulse oximetry). Groups: Patients will be assigned randomly by using a computer -generated table of random numbers into two groups:
- Group A (control group): ( n=25 ): CVL insertion in the right internal jugular vein using ultrasound. The US probe is placed perpendicular to the venous anatomy in the SAX approach.
- Group B (comparative group): ( n=25 ): CVL insertion in the right internal jugular vein using ultrasound. The US probe is aligned at 45° angulation?clockwise with the venous anatomy in the OAX approach.
- procedure Settings: Monitor will be connected and pulse oximetry (SPO2), baseline non-invasive blood pressure (NIBP), heartrate (HR), electrocardiogram (ECG) will be obtained.
In this study, we will use US machine with small linear probe with frequency 5 - 10 Hz and the procedure will be held by the most senior Anaesthesiologist experience in pediatric central venous catheterization for at least 3 years.
The procedure will be held under aseptic condition, Using US, after GA in OR, the anatomical location and patency of the IJV will be assessed with the patient placed in the Trendelenburg position, with the head slightly rotated to the contralateral side. With all sterile precautions, a 4 french introducer needle mounted on a syringe is inserted into the IJV guided by real time US imaging. Once blood is freely aspirated, the US probe is set aside and the syringe removed from the needle. Then the guide wire will be advanced through the needle into the vessel and the catheter will be advanced using the Seldinger technique after guidewire position is confirmed with US. The guidewire will be then removed. Using US, placement of the catheter in the vein will confirmed following which the catheter will be secured in place using sutures. The position of the CVC wiil be also confirmed by a chest radiograph at the end of the procedure.
In the group A, The US probe will be placed perpendicular to the venous anatomy in the SAX approach.
In the group B, The US probe will be aligned at 45° angulation with the venous anatomy, and combined with an in plane needle insertion technique. The needle will be advanced from lateral to medial.
- Conditions
- Central Line Complication
- Being tested
- Short-axis/out-of-plane approach versus oblique- axis approach for ultrasound-guided internal jugular venous catheter.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Short-axis/out-of-plane approach versus oblique- axis approach for ultrasound-guided internal jugular venous catheter.Procedure or surgery
In the group A, The US probe will be placed perpendicular to the venous anatomy in the SAX approach.
In the group B, The US probe will be aligned at 45° angulation with the venous anatomy, and combined with an in plane needle insertion technique. The needle will be advanced from lateral to medial.
| Study group | Role | What they receive |
|---|---|---|
| Group A (control group): ( n=25 ) | CVL insertion in the right internal jugular vein using ultrasound. The US probe is placed perpendicular to the venous anatomy in the SAX approach. Receives: Procedure: Short-axis/out-of-plane approach versus oblique- axis approach for ultrasound-guided internal jugular venous catheter. | |
| Group B (comparative group): ( n=25 ) | CVL insertion in the right internal jugular vein using ultrasound. The US probe is aligned at 45° angulation clockwise with the venous anatomy in the OAX approach. Receives: Procedure: Short-axis/out-of-plane approach versus oblique- axis approach for ultrasound-guided internal jugular venous catheter. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in the rate of acute complications between the two groups.
acute complications as posterior venous wall puncture (PVWP) (ultrasonographic identification of the needle tip or guidewire at any site deeper than the posterior wall of the IJV during cannulation attempts), skin and subcutaneous hematoma, arterial puncture (any pulsatile blood reflux through the needle observed during the procedure), pneumothorax, hemothorax and catheter misplacement (catheter tip identified at any place other than the superior vena cava in the control chest radiograph)
Measured: Post-procedure, through study completion (average 1 year)
Secondary outcomes (4)
Difference in the rate of first successful cannulation attempt.
first successful cannulation attempt (successful venous puncture and successful smooth insertion of guidewire from the first needle puncture without withdrawal of the needle)
Measured: Post procedure, through study completion (average 1 year)
the flash time.
time to completion flash time (The time interval between skin puncture and observing blood at the syringe hub)
Measured: Post procedure, through study completion (average 1 year)
the number of needle redirection.
number of needle redirection (redirection of the needle without complete withdrawal of the needle)
Measured: Post procedure, through study completion (average 1 year)
unsuccessful cannulation.
unsuccessful cannulation (a cannulation is considered unsuccessful if it had to be performed using an approach that differed from that to which the patient had been initially chosen for and also if the operator was unable to cannulate the vein within 3 attempts)
Measured: Post procedure, through study completion (average 1 year)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2024
- Study start1 Apr 2024
- Primary completion15 Sep 2024
- Study completion15 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Central Line ComplicationStudies of the same condition, open and under way.
- More trials run by Ain Shams 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (actual)
- Target duration
- 2 Days
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Engy Y Attallah, M.B.B.C.H, Principal investigator, Anesthesia resident Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06652490
- Sponsor's protocol ID
- FMASU MS60/2024
- Status last verified
- Feb 2024
- First submitted
- 1 Oct 2024
- Last updated
- 5 Nov 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All dana will be shared once study is completed
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Short-axis/out-of-plane Approach Versus Oblique- Axis Approach for Ultrasound-guided Internal Jugular Venous Catheterization in Infants.
- ClinicalTrials.gov ID
- NCT06652490
- Acronym / sponsor ID
- FMASU MS60/2024
- Conditions
- Central Line Complication
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 1 Apr 2024 (actual)
- Primary completion
- 15 Sep 2024 (actual)
- Study completion
- 15 Sep 2024 (actual)
- First posted
- 22 Oct 2024 (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.
The investigators will measure and compare the rate of acute complications, success rate, number of attempts to successful cannulation between ultrasound-guided short axis approach and oblique axis approach during internal jugular venous catheterization in infants.
Detailed description
- pre-procedure settings: The history will be obtained from patient's parents. Investigations will be checked to all patients as (complete blood picture and coagulation profile) to avoid coagulopathy and thrombocytopenia. All patients will be attached to standard monitoring (blood pressure (non-invasive), heart rate, and pulse oximetry). Groups: Patients will be assigned randomly by using a computer -generated table of random numbers into two groups:
- Group A (control group): ( n=25 ): CVL insertion in the right internal jugular vein using ultrasound. The US probe is placed perpendicular to the venous anatomy in the SAX approach.
- Group B (comparative group): ( n=25 ): CVL insertion in the right internal jugular vein using ultrasound. The US probe is aligned at 45° angulation?clockwise with the venous anatomy in the OAX approach.
- procedure Settings: Monitor will be connected and pulse oximetry (SPO2), baseline non-invasive blood pressure (NIBP), heartrate (HR), electrocardiogram (ECG) will be obtained.
In this study, we will use US machine with small linear probe with frequency 5 - 10 Hz and the procedure will be held by the most senior Anaesthesiologist experience in pediatric central venous catheterization for at least 3 years.
The procedure will be held under aseptic condition, Using US, after GA in OR, the anatomical location and patency of the IJV will be assessed with the patient placed in the Trendelenburg position, with the head slightly rotated to the contralateral side. With all sterile precautions, a 4 french introducer needle mounted on a syringe is inserted into the IJV guided by real time US imaging. Once blood is freely aspirated, the US probe is set aside and the syringe removed from the needle. Then the guide wire will be advanced through the needle into the vessel and the catheter will be advanced using the Seldinger technique after guidewire position is confirmed with US. The guidewire will be then removed. Using US, placement of the catheter in the vein will confirmed following which the catheter will be secured in place using sutures. The position of the CVC wiil be also confirmed by a chest radiograph at the end of the procedure.
In the group A, The US probe will be placed perpendicular to the venous anatomy in the SAX approach.
In the group B, The US probe will be aligned at 45° angulation with the venous anatomy, and combined with an in plane needle insertion technique. The needle will be advanced from lateral to medial.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Days
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A (control group): ( n=25 ) | – | Procedure: Short-axis/out-of-plane approach versus oblique- axis approach for ultrasound-guided internal jugular venous catheter.CVL insertion in the right internal jugular vein using ultrasound. The US probe is placed perpendicular to the venous anatomy in the SAX approach. |
| Group B (comparative group): ( n=25 ) | – | Procedure: Short-axis/out-of-plane approach versus oblique- axis approach for ultrasound-guided internal jugular venous catheter.CVL insertion in the right internal jugular vein using ultrasound. The US probe is aligned at 45° angulation clockwise with the venous anatomy in the OAX approach. |
Who may qualify
- Ages
- 1 month to 12 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- This study will be carried out on infants who require central venous access through IJV as part of their management in operating room (OR) if they consented to be part of the study from their parents.
Key inclusion criteria (2 listed)
- Age between 1 month and 12 months
- Physical status: patients requiring CVC in their management
Key exclusion criteria (5 listed)
- patient's parents refuse to do the study
- Coagulopathy (INR > 1.5, platelets count < 50.000), use of anti-coagulant or anti platelet therapy) (Sunny et al, 2022)
- Infection, wounds or subcutaneous hematoma close to the puncture site
- history of previous surgical intervention at the cannulation site
- subcutaneous emphysema, penetrating neck trauma or cervical trauma
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 |
|---|---|---|
| Short-axis/out-of-plane approach versus oblique- axis approach for ultrasound-guided internal jugular venous catheter.In the group A, The US probe will be placed perpendicular to the venous anatomy in the SAX approach. In the group B, The US probe will be aligned at 45° angulation with the venous anatomy, and combined with an in plane needle insertion technique. The needle will be advanced from lateral to medial. | Procedure or surgery | Group A (control group): ( n=25 ), Group B (comparative group): ( n=25 ) |
Primary outcome
Difference in the rate of acute complications between the two groups.
Time frame: Post-procedure, through study completion (average 1 year)
acute complications as posterior venous wall puncture (PVWP) (ultrasonographic identification of the needle tip or guidewire at any site deeper than the posterior wall of the IJV during cannulation attempts), skin and subcutaneous hematoma, arterial puncture (any pulsatile blood reflux through the needle observed during the procedure), pneumothorax, hemothorax and catheter misplacement (catheter tip identified at any place other than the superior vena cava in the control chest radiograph)
4 secondary outcomes
Difference in the rate of first successful cannulation attempt.
Time frame: Post procedure, through study completion (average 1 year)
the flash time.
Time frame: Post procedure, through study completion (average 1 year)
the number of needle redirection.
Time frame: Post procedure, through study completion (average 1 year)
unsuccessful cannulation.
Time frame: Post procedure, through study completion (average 1 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 5 Nov 2024.
- Individual participant dataSharing planned: Yes. All dana will be shared once study is completed
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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.
Engy Y Attallah, M.B.B.C.H principal investigator
Anesthesia resident Ain Shams University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Central Line Complication, run by Ain Shams 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 2 inclusion and 5 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 5 Nov 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?
Difference in the rate of acute complications between the two groups. (time frame: Post-procedure, through study completion (average 1 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 5 Nov 2024.