The Optimal Leg Angulation of Femoral Central Catheterization in Pediatrics

Emergencies Clinical Trial

Official title:

The Optimal Leg Angulation of Femoral Central Catheterization in Pediatrics

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03358446
• Other study ID #: 2017-09-027
• Status: Completed
• Start date: October 11, 2017
• Est. completion date: May 31, 2018

Study information

• Verified date: September 2017
• Source: Samsung Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 82
• Est. completion date: May 31, 2018
• Est. primary completion date: March 23, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A to 36 Months

Eligibility

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.

Related Conditions & MeSH terms

• Emergencies
• Femoral Artery Injury
• Pediatric Disorder

Intervention

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
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.

Locations

Country	Name	City	State
Korea, Republic of	Samsung Medical Center, Sungkyunkwan University, School of Medicine	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Samsung Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)