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CompletedNCT03358446Updated Jul 19, 2018

The Optimal Leg Angulation of Femoral Central Catheterization in Pediatrics

An observational study in Pediatric Disorder, Femoral Artery Injury and Emergencies, sponsored by Samsung Medical Center. Completed at 1 site in Korea, Republic of. Open to participants aged Up to 36 Months, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-07-19.

Primary conditionnone(registry's first term: Emergencies)No conditionIs this wrong?Emergencies describes something many studies share rather than a condition a study is about. The study names no condition we can place it under, so it is not compared with other studies by condition.

Sponsored by Samsung Medical Center · Observational

Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
82
Ages
Up to 36 Months
Sex
All
01

Study summary

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.

02

Conditions studied

  • Pediatric Disorder
  • Femoral Artery Injury
  • Emergencies

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Keywords

  • central catheterization
  • femoral vein central catheterization
  • leg angulation
03

In context

Lead sponsor

Samsung Medical Center is the lead sponsor of 1,011 studies on the registry; 152 are open to participants now.

Of its 7 completed or terminated interventional studies of FDA-regulated products, 1 (14%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Up to 36 Months
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Probability sample

Study population

Patients scheduled for elective surgery.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Pediatric patients younger than 3 years
  2. 1-3
  3. Patients scheduled for elective surgery.
  4. If the patient's guardian can understand and write the contents of the agreement.

Exclusion criteria

Exclusion Criteria:

  1. A patient with previous history of dislocation of the hip.
  2. Hip joints with limited hip movement.
  3. A patient with vascular malformation of the femoral vein
  4. Emergency surgery
  5. Hemodynamic unstable patient
  6. If the patient's guardian cannot understand and write the contents of the agreement.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

ASA physical status

The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.

05

Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
82 participants (actual)
Patient registry
No

Groups and cohorts

  • 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

    Other: A group

  • S group

    S group is the patients without non-overlapping range

    Other: S group

Interventions

  • OtherA group

    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.

  • OtherS group

    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.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Intraoperative ( after anesthesia induction)

07

Study locations

1 site
  • Samsung Medical Center, Sungkyunkwan University, School of Medicine
    Seoul, 135-710, Korea, Republic of
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 19, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT03358446
Responsible party
Sponsor
First posted
Nov 30, 2017
Start date
Oct 11, 2017
Primary completion
Mar 23, 2018
Completion
May 31, 2018
Last update
Jul 19, 2018

Study contacts

jonghwan lee, MD, PhD
principal investigator · Samsung Medical Center, Sungkyunkwan University School of Medicine

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Sep 2017. You cannot join it, but the record below documents what was studied.

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