Complications After Arterial CatheterizationNCT03784118
Complications Associated with Arterial Line Placement in Children
A study testing Ultrasonography and perfusion index in people with Complications After Arterial Catheterization, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
The purpose of this study is to find the risk factors for complications following arterial line catheterization. Ultrasonography is used to evaluate the size of artery which is cannulated, before and after catheterization. The complications include ischemia, bleeding, thrombosis and so on. Read more about this study
- Who is it for?
- Ages Up to 5 years
- Conditions the study is for
- Complications After Arterial Catheterization
- What is being tested?
- Ultrasonography and perfusion index
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 82 participants
- Where
- 1 siteSouth Korea
- Study dates
- 10 Jan 2019to 2 Sep 2023
- 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 Up to 5 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Pediatric patients under 5 years of age who require invasive arterial pressure monitoring
Who cannot join
- Patients who do not need invasive arterial pressure monitoring
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Study on Complications After Arterial Line Placement and the Risk Factors in Children
The purpose of this study is to find the risk factors for complications following arterial line catheterization. Ultrasonography is used to evaluate the size of artery which is cannulated, before and after catheterization. The complications include ischemia, bleeding, thrombosis and so on.
Read the detailed description
artery observation with ultrasound
- Being tested
- Ultrasonography, perfusion index
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UltrasonographyDiagnostic test
Ultrasonography is used to evaluate the change in artery size after arterial catheterization and to assess the complication in children
perfusion indexDiagnostic test
measurement of perfusion index immediately after arterial catheterization until surgery end, in arterial catheterization site and contralateral site.
| Study group | Role | What they receive |
|---|---|---|
| Children | Experimental | Children who are followed up after arterial catheterization for evaluation of complications, using ultrasonography Receives: Diagnostic Test: Ultrasonography; Diagnostic Test: perfusion index |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of complications associated with arterial catheterization
Number of participants with complications following arterial catheterization. The complications include thrombus, ischemia, oozing or bleeding, and color change, etc. If any of these occur, it is assumed that complications have occurred.
Measured: within 5 days after arterial catheterization
Secondary outcomes (4)
Time-dependent changes in perfusion index
Perfusion index was continuously monitored throughout surgery, on both sides: the digit on the side of the arterial line placement and the opposite side
Measured: from arterial catheterization to the end of surgery
Age as a risk factor
To evaluate the age as one of the risk factors for complications following arterial catheterization using univariable logistic regression analysis.
Measured: within 5 days after arterial catheterization
Number of attempts as a risk factor
To evaluate the number of attempts of arterial catheterization as one of the risk factors for complications
Measured: within 5 days after arterial catheterization
Duration of catheterization as a risk factor
To evaluate the duration of catheterization as one of the risk factors for complications
Measured: within 5 days after arterial catheterization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2018
- Study start10 Jan 2019
- Primary completion31 Aug 2023
- Study completion2 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Complications After Arterial CatheterizationStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe 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
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 82 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hee-Soo Kim, Seoul National University Hospital
- Investigators
- Hee-Soo Kim Kim, PhD, Principal investigator, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03784118
- Sponsor's protocol ID
- H1812-032-991
- Status last verified
- Oct 2024
- First submitted
- 11 Dec 2018
- Last updated
- 17 Oct 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Lee JH, Park JB, Ji SH, Jang YE, Kim EH, Kim JT, Kim HS. Immediate complications and risk factors following radial arterial catheterisation in paediatric patients at a tertiary centre. Eur J Anaesthesiol. 2026 May 1;43(5):386-394. doi: 10.1097/EJA.0000000000002268. Epub 2025 Sep 5.
PubMed 40923190
Study at a glance
From the registry record, last updated by the sponsor on 17 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study on Complications After Arterial Line Placement and the Risk Factors in Children
- ClinicalTrials.gov ID
- NCT03784118
- Acronym / sponsor ID
- H1812-032-991
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 82 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- 10 Jan 2019 (actual)
- Primary completion
- 31 Aug 2023 (actual)
- Study completion
- 2 Sep 2023 (actual)
- First posted
- 21 Dec 2018 (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 purpose of this study is to find the risk factors for complications following arterial line catheterization. Ultrasonography is used to evaluate the size of artery which is cannulated, before and after catheterization. The complications include ischemia, bleeding, thrombosis and so on.
Detailed description
artery observation with ultrasound
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Children | Experimental | Diagnostic Test: Ultrasonography, Diagnostic Test: perfusion indexChildren who are followed up after arterial catheterization for evaluation of complications, using ultrasonography |
Who may qualify
- Ages
- Up to 5 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Pediatric patients under 5 years of age who require invasive arterial pressure monitoring
Key exclusion criteria (1 listed)
- Patients who do not need invasive arterial pressure monitoring
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 |
|---|---|---|
| UltrasonographyUltrasonography is used to evaluate the change in artery size after arterial catheterization and to assess the complication in children | Diagnostic test | Children |
| perfusion indexmeasurement of perfusion index immediately after arterial catheterization until surgery end, in arterial catheterization site and contralateral site. | Diagnostic test | Children |
Primary outcome
Incidence of complications associated with arterial catheterization
Time frame: within 5 days after arterial catheterization
Number of participants with complications following arterial catheterization. The complications include thrombus, ischemia, oozing or bleeding, and color change, etc. If any of these occur, it is assumed that complications have occurred.
4 secondary outcomes
Time-dependent changes in perfusion index
Time frame: from arterial catheterization to the end of surgery
Age as a risk factor
Time frame: within 5 days after arterial catheterization
Number of attempts as a risk factor
Time frame: within 5 days after arterial catheterization
Duration of catheterization as a risk factor
Time frame: within 5 days after arterial catheterization
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 17 Oct 2024.
- Derived from this study: PubMed 40923190Lee JH, Park JB, Ji SH, Jang YE, Kim EH, Kim JT, Kim HS. Immediate complications and risk factors following radial arterial catheterisation in paediatric patients at a tertiary centre. Eur J Anaesthesiol. 2026 May 1;43(5):386-394. doi: 10.1097/EJA.0000000000002268. Epub 2025 Sep 5.
- Individual participant dataSharing planned: No
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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.
Hee-Soo Kim Kim, PhD principal investigator
Seoul National University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ultrasonography and perfusion index in people with Complications After Arterial Catheterization, run by Seoul National University Hospital at 1 site in South Korea.
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 1 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 17 Oct 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 South Korea. 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?
Incidence of complications associated with arterial catheterization (time frame: within 5 days after arterial catheterization). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03784118, which also lists 1 linked publication.
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 17 Oct 2024.