The Optimal Leg Angulation of Femoral Central Catheterization in Pediatrics

NCT03358446 | Completed DMC

• 1 other identifier: 2017-09-027
• Study Type: observational
• Target: 82
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Pediatric Disorder; Femoral Artery Injury; Emergencies

Keywords

central catheterization; femoral vein central catheterization; leg angulation

Outcome Measures

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.

  Intraoperative ( after anesthesia induction)

Study Arms (2)

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

A group OTHER

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.

A group

S group OTHER

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.

S group

Eligibility Criteria

• Age: Up to 36 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

Study Population

Patients scheduled for elective surgery.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Samsung Medical Center: lead

Study Sites (1)

Samsung Medical Center, Sungkyunkwan University, School of Medicine

Seoul, 135-710, South Korea

Location

MeSH Terms

Conditions

Emergencies

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• jonghwan lee, MD, PhD

  Samsung Medical Center, Sungkyunkwan University School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 26, 2017
• First Posted: November 30, 2017
• Study Start: October 11, 2017
• Primary Completion: March 23, 2018
• Study Completion: May 31, 2018
• Last Updated: July 19, 2018

Record last verified: 2017-09

Locations

KR (1)