The Optimal Leg Angulation of Femoral Central Catheterization in Pediatrics

Evaluation for the range of smallest leg angulation with femoral artery and vein overlap with femoral central catheterization in pediatrics.

Study Overview

• Status: Completed
• Conditions: Emergencies; Pediatric Disorder; Femoral Artery Injury
• Intervention / Treatment: Other: A group; Other: S group

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 Type: Observational
• Enrollment (Actual): 82

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 3 years (CHILD)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Patients scheduled for elective surgery.

Description

Inclusion Criteria:

1. Pediatric patients younger than 3 years
2. ASA class 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:

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; 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 group; S group is the patients without non-overlapping range	Other: S 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Intraoperative ( after anesthesia induction)

Collaborators and Investigators

• Sponsor: Samsung Medical Center
• Investigators: Principal Investigator: jonghwan lee, MD, PhD, Samsung Medical Center, Sungkyunkwan University School of Medicine

Study record dates

Study Major Dates

• Study Start (ACTUAL): October 11, 2017
• Primary Completion (ACTUAL): March 23, 2018
• Study Completion (ACTUAL): May 31, 2018

Study Registration Dates

• First Submitted: November 26, 2017
• First Submitted That Met QC Criteria: November 29, 2017
• First Posted (ACTUAL): November 30, 2017

Study Record Updates

• Last Update Posted (ACTUAL): July 19, 2018
• Last Update Submitted That Met QC Criteria: July 17, 2018
• Last Verified: September 1, 2017

More Information

Terms related to this study

• Keywords: central catheterization; femoral vein central catheterization; leg angulation
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Emergencies
• Other Study ID Numbers: 2017-09-027

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No