Ultrasound GuidedNCT06575491
Ultrasound Guided Supraclavicular and Infraclavicular Subclavian vs Catheterization in Pediatric
A study testing Ultrasound-guided supraclavicular approach and Ultrasound-guided infraclavicular approach in people with Ultrasound Guided and Supraclavicular, run by Al-Azhar University at 1 site in Egypt.
Trial summary
The aim of this study was to compare between ultrasound-guided supraclavicular and infraclavicular approaches for subclavian venous catheterization in pediatric to get clinical practice of rapid, accurate central venous catheter, insertion and less Complications. Read more about this study
- Who is it for?
- Ages 4 to 12 years
- Conditions the study is for
- Ultrasound Guided, Supraclavicular, Infraclavicular
- What is being tested?
- Ultrasound-guided supraclavicular approach and Ultrasound-guided infraclavicular approach
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Sep 2023to 1 Jun 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 4 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Aged from 4 to 12 years.
- Both sexes.
- All children who need central venous line insertion.
- Intra-operative Hemodynamic monitoring.
- Volume and Inotrope Resuscitation.
- Difficult Peripheral IV Access.
- Intravenous Nutrition and Medications.
Who cannot join
- Coagulopathy.
- Distorted anatomy.
- Infection systemic or cutaneous near the proposed Point of insertion.
- Skeletal deformity.
- History of previous neck surgery.
- Head and neck mass.
- Guardian Refusal.
- Pneumothorax Or Hemothorax.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparative Evaluation of Ultrasound Guided Supraclavicular and Infraclavicular Subclavian Venous Catheterization in Pediatric
The aim of this study was to compare between ultrasound-guided supraclavicular and infraclavicular approaches for subclavian venous catheterization in pediatric to get clinical practice of rapid, accurate central venous catheter, insertion and less Complications.
Read the detailed description
Vascular access in children can be challenging. There is a considerable body of evidence supporting the use of ultrasound to aid central venous access in adults, but less so in children. Benefits for experienced operators may be small, but there is evidence of benefit for those acquiring skills and for less frequent operators.
Central venous catheter (CVC) placement is one of the most important invasive procedures in the intensive care for children of all ages. And health care outcomes largely depend on the success of its implementation. There are a large number of historically and clinically significant methods of central venous catheterization, and the advantages and disadvantages of each of them have been discussed for many years.
Ultrasonography is becoming an increasingly useful adjunct in the placement of Percutaneous central lines.
- Conditions
- Ultrasound Guided, Supraclavicular, Infraclavicular, Subclavian, Venous Catheterization, Pediatric
- Being tested
- Ultrasound-guided supraclavicular approach, Ultrasound-guided infraclavicular approach
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound-guided supraclavicular approachDevice
Patients submitted to Supraclavicular approach for ultrasound-guided Subclavian veinous catheterization.
Ultrasound-guided infraclavicular approachDevice
Patients submitted to Infraclavicular approach for ultrasound-guided Subclavian veinous catheterization.
| Study group | Role | What they receive |
|---|---|---|
| Supraclavicular group | Experimental | Patients submitted to Supraclavicular approach for ultrasound-guided Subclavian veinous catheterization. Receives: Device: Ultrasound-guided supraclavicular approach |
| Infraclavicular group | Experimental | Patients submitted to Infraclavicular approach for ultrasound-guided Subclavian veinous catheterization. Receives: Device: Ultrasound-guided infraclavicular approach |
What is being measured
The primary outcome is the main question the study is designed to answer.
Puncture time
Puncture time was recorded.
Measured: Interoperatively
Secondary outcomes (4)
Total access time
Total access time was recorded
Measured: Interoperatively
First attempt success rate
First attempt success rate was recorded
Measured: Interoperatively
Quality of needle visualization
Quality of needle visualization was recorded
Measured: Interoperatively
Incidence of complication
Incidence of complication was recorded such as complication rates.failure rate haematoma, pneumothorax
Measured: 24 hours postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2024
- Study start1 Sep 2023
- Primary completion1 Jun 2024
- Study completion1 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ultrasound GuidedStudies of the same condition, open and under way.
- More trials run by Al-Azhar 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Al-Azhar University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Radi Mohamed Radi Mostafa, Al-Azhar University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06575491
- Sponsor's protocol ID
- 0377/2023
- Status last verified
- Aug 2024
- First submitted
- 26 Aug 2024
- Last updated
- 28 Aug 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data was available upon a reasonable request from the corresponding author after the end of study for one year.
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Evaluation of Ultrasound Guided Supraclavicular and Infraclavicular Subclavian Venous Catheterization in Pediatric
- ClinicalTrials.gov ID
- NCT06575491
- Acronym / sponsor ID
- 0377/2023
- Conditions
- Ultrasound Guided, Supraclavicular, Infraclavicular, Subclavian, Venous Catheterization, Pediatric
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Al-Azhar UniversityUniversity, hospital or other
- Study start
- 1 Sep 2023 (actual)
- Primary completion
- 1 Jun 2024 (actual)
- Study completion
- 1 Jun 2024 (actual)
- First posted
- 28 Aug 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 aim of this study was to compare between ultrasound-guided supraclavicular and infraclavicular approaches for subclavian venous catheterization in pediatric to get clinical practice of rapid, accurate central venous catheter, insertion and less Complications.
Detailed description
Vascular access in children can be challenging. There is a considerable body of evidence supporting the use of ultrasound to aid central venous access in adults, but less so in children. Benefits for experienced operators may be small, but there is evidence of benefit for those acquiring skills and for less frequent operators.
Central venous catheter (CVC) placement is one of the most important invasive procedures in the intensive care for children of all ages. And health care outcomes largely depend on the success of its implementation. There are a large number of historically and clinically significant methods of central venous catheterization, and the advantages and disadvantages of each of them have been discussed for many years.
Ultrasonography is becoming an increasingly useful adjunct in the placement of Percutaneous central lines.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Supraclavicular group | Experimental | Device: Ultrasound-guided supraclavicular approachPatients submitted to Supraclavicular approach for ultrasound-guided Subclavian veinous catheterization. |
| Infraclavicular group | Experimental | Device: Ultrasound-guided infraclavicular approachPatients submitted to Infraclavicular approach for ultrasound-guided Subclavian veinous catheterization. |
Who may qualify
- Ages
- 4 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- Aged from 4 to 12 years.
- Both sexes.
- All children who need central venous line insertion.
- Intra-operative Hemodynamic monitoring.
- Volume and Inotrope Resuscitation.
Key exclusion criteria (8 listed)
- Coagulopathy.
- Distorted anatomy.
- Infection systemic or cutaneous near the proposed Point of insertion.
- Skeletal deformity.
- History of previous neck surgery.
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 |
|---|---|---|
| Ultrasound-guided supraclavicular approachPatients submitted to Supraclavicular approach for ultrasound-guided Subclavian veinous catheterization. | Device | Supraclavicular group |
| Ultrasound-guided infraclavicular approachPatients submitted to Infraclavicular approach for ultrasound-guided Subclavian veinous catheterization. | Device | Infraclavicular group |
Primary outcome
Puncture time
Time frame: Interoperatively
Puncture time was recorded.
4 secondary outcomes
Total access time
Time frame: Interoperatively
First attempt success rate
Time frame: Interoperatively
Quality of needle visualization
Time frame: Interoperatively
Incidence of complication
Time frame: 24 hours postoperatively
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 28 Aug 2024.
- Individual participant dataSharing planned: Yes. The data was available upon a reasonable request from the corresponding author after the end of study for one year.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ultrasound-guided supraclavicular approach and Ultrasound-guided infraclavicular approach in people with Ultrasound Guided and Supraclavicular, run by Al-Azhar 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 7 inclusion and 8 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 28 Aug 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?
Puncture time (time frame: Interoperatively). 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 28 Aug 2024.