Saphenous Vein Cannulation in Infants and Small Children

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

102 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-07-31

Study Completion Date

2014-07-31

Brief Summary

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The purpose of this study is to compare the two different saphenous vein cannulation techniques; real-time ultrasound image-guided technique (Ultrasound group) vs. traditional landmark technique (Landmark group).

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Detailed Description

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Conditions

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Saphenous Vein Cannulation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Participants

Study Groups

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Landmark group

An operator is not allowed to use an ultrasound. A 22 or 24 G catheter will be advanced blindly toward the expected location of the saphenous vein at the level of the medial malleolus. Once blood appears in the hub, then the catheter will be advanced into the saphenous vein.

Group Type ACTIVE_COMPARATOR

Saphenous vein cannulation

Intervention Type PROCEDURE

Intravenous cannulation to saphenous vein

A 22 or 24 G intravenous catheter

Intervention Type DEVICE

Ultrasound group

An operator will identify the saphenous vein by using ultrasound with a linear transducer (L15-7io) in short axis view. A 22 or 24 G catheter will be advanced until the tip of the needle is seen on the ultrasound image. The needle is then advanced until blood appears in the hub. The catheter is then advanced into the saphenous vein.

Group Type ACTIVE_COMPARATOR

Saphenous vein cannulation

Intervention Type PROCEDURE

Intravenous cannulation to saphenous vein

ultrasound with a linear transducer (L15-7io)

Intervention Type DEVICE

Portable, bed-side ultrasound to detect saphenous vein

A 22 or 24 G intravenous catheter

Intervention Type DEVICE

Interventions

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Saphenous vein cannulation

Intravenous cannulation to saphenous vein

Intervention Type PROCEDURE

ultrasound with a linear transducer (L15-7io)

Portable, bed-side ultrasound to detect saphenous vein

Intervention Type DEVICE

A 22 or 24 G intravenous catheter

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

1. Pediatric patient undergoing scheduled surgery which requires venous cannulation.
2. Term neonates and children \< 4 years old weighing \>/= 3 kg

Exclusion Criteria

1. Patient with visible saphenous vein
2. Patient with no detectable saphenous vein under ultrasound
3. Patient with a skin wound or infection around puncture site
4. Patient with recent venous puncture at the puncture site (less than 1 month)
5. Patient with thrombus in saphenous vein or hematoma formation around the vein detected by ultrasound.
6. Patient with any emergency surgery

Maximum Eligible Age

4 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No