The Optimal Leg Angulation of Femoral Central Catheterization in Pediatrics

NCT ID: NCT03358446

Last Updated: 2018-07-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

82 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-10-11

Study Completion Date

2018-05-31

Brief Summary

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

Detailed Description

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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

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Pediatric Disorder Femoral Artery Injury Emergencies

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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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

A group

Intervention Type 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.

S group

S group is the patients without non-overlapping range

S group

Intervention Type 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.

Interventions

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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.

Intervention Type 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.

Intervention Type OTHER

Eligibility Criteria

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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.
Maximum Eligible Age

36 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Samsung Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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jonghwan lee, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Samsung Medical Center, Sungkyunkwan University School of Medicine

Locations

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Samsung Medical Center, Sungkyunkwan University, School of Medicine

Seoul, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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2017-09-027

Identifier Type: -

Identifier Source: org_study_id

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