Pediatric DisorderNCT03358446
The Optimal Leg Angulation of Femoral Central Catheterization in Pediatrics
An observational study of Pediatric Disorder and Femoral Artery Injury, run by Samsung Medical Center at 1 site in South Korea.
Trial summary
Evaluation for the range of smallest leg angulation with femoral artery and vein overlap with femoral central catheterization in pediatrics. Read more about this study
- Who is it for?
- Ages Up to 36 monthsHealthy volunteers can take part
- Conditions the study is for
- Pediatric Disorder, Femoral Artery Injury, Emergencies
- What is being tested?
- A group and S group
- How many people
- 82 participants
- Where
- 1 siteSouth Korea
- Study dates
- 11 Oct 2017to 31 May 2018
- 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 Up to 36 months
- All sexes
- Healthy volunteers accepted
- Child
Study population: Patients scheduled for elective surgery.
Who may be able to join
- Pediatric patients younger than 3 years
- ASA class 1-3
- Patients scheduled for elective surgery.
- If the patient's guardian can understand and write the contents of the agreement.
Who cannot join
- A patient with previous history of dislocation of the hip.
- Hip joints with limited hip movement.
- A patient with vascular malformation of the femoral vein
- Emergency surgery
- Hemodynamic unstable patient
- If the patient's guardian cannot understand and write the contents of the agreement.
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Samsung Medical Center, Sungkyunkwan University, School of Medicine
Seoul, 135-710
About this study
Evaluation for the range of smallest leg angulation with femoral artery and vein overlap with femoral central catheterization in pediatrics.
Read the detailed description
In pediatrics, femoral vein catheterization often overlaps with the femoral artery.
In this case, the risk of artery puncture is high, vein collapse when artery puncture 2nd, 3rd times exceeds the success rate of catheterization becomes low. In previous study, comparing 0, 30, and 60 degrees with frog leg position, there was a study that the overlap was the smallest at 60 degrees. A previous study was a simple frog leg position and a study in fragmented predetermined angles. On a continuous measurement, we planned the study under the assumption that there is a more definite range of optimal angulation.
Ultrasound probe in the state of Inguinal crease, we find a part without bifurcation of femoral artery and femoral vein in frog leg position(external rotation + flexion increase). Increase the leg angle and check the vein and arterie relations.
- Conditions
- Pediatric Disorder, Femoral Artery Injury, Emergencies
- Being tested
- A group, S group
- Keywords
- central catheterization, femoral vein central catheterization, leg angulation
- Medical subject headings
- Emergencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
A groupOther
The optimal range of leg abduction was defined as the range without overlap in A group and the range presenting that the overlap was less-than half of the diameter of femoral vein in S group.
A1 angle defined the point that the femoral vein and artery started non-overlapping interval when increasing the angle of the leg in the A group and the A2 angle is defined the point that the femoral vein and artery ended non-overlapping interval.
S groupOther
B1 is the angle at which the overlap starts at the half of the femoral vein radius when increasing the angle of the leg in the S group, B2 is the angle at which overlap starts at half or more of the femoral vein radius again. In the range of B1 and B2 angles, they are overlapped by half or less of the femoral vein radius.
| Study group | Role | What they receive |
|---|---|---|
| A group | Based on the presence of non-overlapping range between femoral artery and vein from the initial observation, the patients were divided into following two groups.
A group is the patients with non-overlapping range Receives: Other: A group | |
| S group | S group is the patients without non-overlapping range Receives: Other: S group |
What is being measured
The primary outcome is the main question the study is designed to answer.
A range of angles in which arteries and veins do not overlap
The optimal range of leg abduction was defined as the range without overlap in A group and the range presenting that the overlap was less-than half of the diameter of femoral vein in S group.
Measured: Intraoperative ( after anesthesia induction)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2017
- Study start11 Oct 2017
- Primary completion23 Mar 2018
- Study completion31 May 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pediatric DisorderStudies of the same condition, open and under way.
- More trials run by Samsung Medical CenterThe 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 82 participants (actual)
Sponsor and investigators
- Lead sponsor
- Samsung Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- jonghwan lee, MD, PhD, Principal investigator, Samsung Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03358446
- Sponsor's protocol ID
- 2017-09-027
- Status last verified
- Sep 2017
- First submitted
- 26 Nov 2017
- Last updated
- 19 Jul 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Optimal Leg Angulation of Femoral Central Catheterization in Pediatrics
- ClinicalTrials.gov ID
- NCT03358446
- Acronym / sponsor ID
- 2017-09-027
- Conditions
- Pediatric Disorder, Femoral Artery Injury, Emergencies
- Keywords
- central catheterization, femoral vein central catheterization, leg angulation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 82 participants (actual)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Study start
- 11 Oct 2017 (actual)
- Primary completion
- 23 Mar 2018 (actual)
- Study completion
- 31 May 2018 (actual)
- First posted
- 30 Nov 2017 (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.
Evaluation for the range of smallest leg angulation with femoral artery and vein overlap with femoral central catheterization in pediatrics.
Detailed description
In pediatrics, femoral vein catheterization often overlaps with the femoral artery.
In this case, the risk of artery puncture is high, vein collapse when artery puncture 2nd, 3rd times exceeds the success rate of catheterization becomes low. In previous study, comparing 0, 30, and 60 degrees with frog leg position, there was a study that the overlap was the smallest at 60 degrees. A previous study was a simple frog leg position and a study in fragmented predetermined angles. On a continuous measurement, we planned the study under the assumption that there is a more definite range of optimal angulation.
Ultrasound probe in the state of Inguinal crease, we find a part without bifurcation of femoral artery and femoral vein in frog leg position(external rotation + flexion increase). Increase the leg angle and check the vein and arterie relations.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A group | – | Other: A groupBased on the presence of non-overlapping range between femoral artery and vein from the initial observation, the patients were divided into following two groups. A group is the patients with non-overlapping range |
| S group | – | Other: S groupS group is the patients without non-overlapping range |
Who may qualify
- Ages
- Up to 36 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Patients scheduled for elective surgery.
Key inclusion criteria (4 listed)
- Pediatric patients younger than 3 years
- ASA class 1-3
- Patients scheduled for elective surgery.
- If the patient's guardian can understand and write the contents of the agreement.
Key exclusion criteria (6 listed)
- A patient with previous history of dislocation of the hip.
- Hip joints with limited hip movement.
- A patient with vascular malformation of the femoral vein
- Emergency surgery
- Hemodynamic unstable patient
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 |
|---|---|---|
| A groupThe optimal range of leg abduction was defined as the range without overlap in A group and the range presenting that the overlap was less-than half of the diameter of femoral vein in S group. A1 angle defined the point that the femoral vein and artery started non-overlapping interval when increasing the angle of the leg in the A group and the A2 angle is defined the point that the femoral vein and artery ended non-overlapping interval. | Other | A group |
| S groupB1 is the angle at which the overlap starts at the half of the femoral vein radius when increasing the angle of the leg in the S group, B2 is the angle at which overlap starts at half or more of the femoral vein radius again. In the range of B1 and B2 angles, they are overlapped by half or less of the femoral vein radius. | Other | S group |
Primary outcome
A range of angles in which arteries and veins do not overlap
Time frame: Intraoperative ( after anesthesia induction)
The optimal range of leg abduction was defined as the range without overlap in A group and the range presenting that the overlap was less-than half of the diameter of femoral vein in S group.
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 19 Jul 2018.
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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.
jonghwan lee, MD, PhD principal investigator
Samsung Medical Center
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 Pediatric Disorder and Femoral Artery Injury, run by Samsung Medical Center 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 4 inclusion and 6 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 19 Jul 2018. 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?
A range of angles in which arteries and veins do not overlap (time frame: Intraoperative ( after anesthesia induction)). 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 19 Jul 2018.